Background and Importance Voriconazole is a broad-spectrum antifungal used to treat and prevent Invasive fungal disease (IFD). The application of personalized medication management for VCZ, such as therapeutic drug monitoring (TDM), is the gold standard for attaining therapeutic goals in invasive fungal infections. Infectious disease (ID) pharmacists are the best for ensuring the recommendations are properly implemented. Our study aims to assess the adherence of healthcare teams to VCZ dose individualization and the impact of the ID pharmacy team.

Materials and Methods The study included pediatric oncology patients who received VCZ in the inpatient department and had VCZ TDM level measurements for three months (from January to March 2019) and after implementing the (ID) pharmacy service during the same months in two different years (2020, 2021).

Results The study included 989 patients who received VCZ; only 588/989 patients (59.5%) had VCZ TDM levels. Dose individualization was required for 62.6% (849/1357) levels, while 37.4% (508/1357) levels were in the therapeutic range. The overall compliance rate to the TDM recommendations was 92.9% (789/849). Additionally, there was a significant increase in VCZ dose individualization adherence after ID pharmacy implementation (88.6% (210/237) vs. 94.6% (579/612), p=0.002). The rate of doctor acceptance of the ID pharmacist intervention was 94.7%.

Conclusion and Relevance ID pharmacists' contributions are crucial and can increase clinicians' adherence to individualized dose recommendations.

Background and Importance Anthracyclines are widely used chemotherapeutic agents in the management of breast cancer. Despite their proven efficacy, their use is limited by dose-dependent cardiotoxicity, which may manifest as acute or chronic cardiac injury, ranging from asymptomatic myocardial damage to overt heart failure. Early detection of cardiac injury remains a major challenge in oncology practice. The aim of this study was to assess the clinical value of cardiac troponin measurement for the early detection of anthracycline-induced myocardial injury in patients with breast cancer.

Materials and Methods Sixteen women with breast cancer receiving anthracycline-based chemotherapy were prospectively enrolled from the Medical Oncology Department of the Pierre and Marie Curie Center. Blood samples were collected in heparinized tubes at baseline and during successive chemotherapy cycles. Biochemical analyses included serum urea and creatinine, measured using a Cobas® Roche analyzer, and cardiac troponin T (cTnT), assessed by an immunofluorescence method (Tosoh®).

Results Renal function remained within normal ranges in all patients throughout follow-up, with urea levels between 0.19 and 0.50 g/L and creatinine levels between 2 and 13 mg/L, except for one patient (Patient 12), who developed progressive renal impairment. Cardiac troponin T levels were initially within normal limits (< 0.02 ng/mL) in all patients. However, two patients demonstrated a significant rise in troponin levels during follow-up. In Patient 12, cTnT increased from < 0.02 ng/mL at baseline to 0.04 ng/mL, reaching 0.11 ng/mL at the third follow-up. In Patient 16, cTnT rose from < 0.02 ng/mL to 0.04 ng/mL and subsequently to 0.08 ng/mL. These elevations were associated with documented cardiac injury confirmed by electrocardiography and cardiac imaging. Both patients were referred to and managed by the cardiology department. Patient 12 developed combined nephrotoxicity and cardiotoxicity related to anthracycline therapy.

Conclusion and Relevance Anthracycline-induced cardiotoxicity requires vigilant monitoring to prevent irreversible cardiac damage. Our results reinforce the clinical value of cardiac troponin as an early biomarker of myocardial injury in breast cancer patients treated with anthracyclines. Integrating troponin monitoring into routine clinical practice may facilitate early detection of anthracycline-related cardiac injury.

Background and Importance Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) represent the standard of care for HR+/HER2- breast cancer patients. CDK4/6i main issue is toxicity due to individual variability in plasma concentration. An alternative to standardised dose reduction, which could lead to underdosing and ineffectiveness, is a combined approach of a priori pharmacogenetic and a posteriori pharmacokinetics analysis to define the dose based on CDK4/6i metabolism genes polymorphisms and plasma levels. The aim is to study individual genetic factors that may impact CDK4/6i bioavailability and systemic concentration.

Materials and Methods The pilot ambispectic project enrolls patients with HR+/HER2- breast cancer treated with abemaciclib or ribociclib, according to clinical practice. A baseline blood sample was collected for pharmacogenetic profiling and, in the case of prospective patients, subsequent samples have been collected according to the Therapeutic Drug Monitoring (TDM) programme for pharmacokinetic analysis. Genomic DNA sequencing allows the investigation of polymorphisms in genes involved in CDK4/6i metabolism and toxicity, while TDM allows the determination of drug plasmatic concentration at each administration.

Results As of 2025, 94 patients had been recruited, 47 (50%) of whom candidates for ribociclib treatment, whose main toxicity is neutropenia. Heterozygous carriers of the TTT haplotype for the three polymorphisms in the ABCB1 gene, which encodes for a membrane transporter, have a higher risk of developing severe neutropenia on day 15 of the first treatment cycle (C1G15). 14% of the prospective patients treated with ribociclib developed neutropenia at C1G15, 21% of whom had severe/serious (G3/G4) neutropenia. 80% of patients carrying the predictive haplotype present the expected phenotype, with 25% of G3/4 neutropenia manifestations. Moreover, G3/4 neutropenia is associated with an increased ribociclib plasma concentration. These data demonstrate that individuals affected by same neoplasm respond differently to the same treatment because multiple genetic and non-genetic factors influence treatment outcomes.

Conclusion and Relevance The combined approach of pharmacogenetic profiling and TDM provides the basis for extrapolating predictive factors for toxicity development. The identification of gene variants associated with pharmacokinetics could provide physicians with a tool to personalise CDK4/6i doses to achieve optimal plasma levels, avoiding the risk of adverse reactions and improving patients' quality of life.

Background and Importance Methotrexate (MTX) is a key drug for treating hematologic malignancies. Due to its narrow therapeutic window, Population pharmacokinetic (PopPK) models help predict MTX plasma concentrations (Cp) and optimize folinic acid rescue. This study evaluated and compared the predictive performance and clinical utility in adults with lymphoma/acute lymphoblastic leukaemia (ALL) of two PopPK models (developed by Gallais and Kawakatsu) when two optimisation methods were used for bayesian forecasting: Levenberg-Marquardt (M2) and adaptive Metropolis (SAA).

Materials and Methods Retrospective PK study in adults with lymphoma/ALL treated with MTX. Cp at 24h (lymphoma) and 42h (ALL) were estimated using the two popPK models and optimization methods and compared with observed values. The data were weighted using two approaches: frequency- based (FB) or concentration-based (CB). Predictive performance was evaluated using median percentage error and median absolute percentage error (MDiPE and MDiAPE), the percentage of individual prediction error within ±20% (iF20) and ±30% (iF30) of observed concentrations; clinical utility by folinic acid rescue concordance.

Results Thirty-seven patients (72 MTX cycles) were included: 17 with lymphoma (37 cycles; 52% men; median age 66 [34–73] years) and 20 with ALL (35 cycles; 55% men; median age 46 [17–68] years) with a median of two cycles per patient. Predictive performance and clinical utility are shown in Table 1.

Table 1. Predictive performance and clinical utility of MTX PopPK models

Conclusion and Relevance MTX PopPK models showed significant variability in external populations. The Kawakatsu model showed better overall performance than the Gallais model, although neither provided consistently clinically adequate predictions. In lymphoma, Kawakatsu SAA-FB stood out for its better predictive ability and high concordance with folinic acid rescue. In ALL, no model achieved sufficient accuracy. Disease Parameters (%) M2-BC M2-BF SAA-CB SAA-FB

Galla is Kawakat su Gallais Kawaka tsu Gallais Kawakat su Gallais Kawakat su Lymphoma MDiPE -10.0 -33.3 -9.0 -23,3 -58.8 -24.5 -21.7 8.5

MDiAPE 42.5 50.2 35.6 31.8 59.8 57.1 32.0 30.3 iF20 16.2 21.6 39.7 27.0 13.5 10.8 32.4 37.8 iF30 29.7 32.4 37.8 40.5 8.1 21.6 48.7 48.7 Folinic rescue concordance 64.9 86.5 81.1 75.7 83.8 83.9 81.1 83.8 ALL MDiPE -26.1 -4.6 -27.3 -13.3 -69.0 -45.7 -26.1 -27.3

MDiAPE 50.0 44.3 40.2 43.0 60.0 73.8 53.7 44.2 iF20 22.9 28.6 28.6 34.3 5.7 2.9 25.7 25.7 iF30 34.3 34.3 42.9 37.1 11.4 11.4 37.1 42.9 Folinic rescue concordance 45.7 54.3 51.4 54.3 37.1 40.0 45.7 54.3

Background and Importance Chemotherapy-induced toxicities present a significant challenge in pediatric oncology, leading to treatment interruptions, morbidity, and reduced survival rates in low-resource environments. The variability in genetic profiles plays a critical role in drug metabolism, transport, and detoxification. However, there is a scarcity of data regarding the genetic profiles of African children undergoing chemotherapy. This study aims to explore the distribution of selected pharmacogenomic variants and their clinical correlates in relation to chemotherapy-induced toxicities in Tanzania.

Materials and Methods A cross-sectional study was successfully conducted involving 155 pediatric cancer patients aged 1–17 years who were receiving chemotherapy at Bugando Medical Centre, Tanzania. The research gathered an extensive array of clinical data, clinician-observed toxicities, patient- reported outcomes, and blood samples for SNP genotyping. Eleven pharmacogenomic variants across crucial drug-metabolism pathways, including CYP3A5, SLC19A1, TPMT, NUDT15, GSTP1, NCF4, CYBA, and CEP72 were meticulously genotyped using the Agena MassARRAY® platform.

Results Hematologic toxicities were common, with anemia (50.3%) and leukopenia (37.4%) predominating, alongside mucocutaneous effects including alopecia (38.1%) and oral ulcers (24.5%). Vincristine-induced peripheral neuropathy affected 78.1% of patients. TPMT2, TPMT3B, and NUDT15 variants were monomorphic. Reduced-function CYP3A5 alleles were frequent, with CYP3A56 carriers at 38.1% and CYP3A53 at 27.7%. GSTP1 rs1695 showed high polymorphism (MAF 0.46), while CYBA rs4673 (63.9%) and NCF4 rs1883112 (23.2%) demonstrated notable variation. SLC19A1 rs1051296 displayed balanced allele distribution (MAF 0.49). These findings indicate substantial genetic variability influencing chemotherapy metabolism, oxidative stress response, and methotrexate transport, potentially contributing to the high burden of observed toxicities in this pediatric population.

Conclusion and Relevance The current study offers critical baseline data on pharmacogenomic variation among Tanzanian children with cancer, revealing considerable diversity in genes associated with drug metabolism and susceptibility to toxicity. These findings highlight the promising potential of incorporating pharmacogenomic profiling into pediatric oncology care in Tanzania.

Background and Importance Busulfan is a drug used in myeloablative conditioning regimens for patients prior to hematopoietic stem cell transplantation, with long-standing clinical use. However, data predicting the relationship between blood drug levels, efficacy, and safety in adult Thai populations remain limited. This study aimed to investigate the relationship between busulfan AUC values and both therapeutic efficacy and adverse events, as well as to evaluate patient- specific factors influencing AUC.

Materials and Methods This retrospective cohort study collected data from medical records at Chulalongkorn Hospital, Thai Red Cross Society, from patients aged ≥18 years who received busulfan as part of conditioning regimens between January 2020 and December 2024 (n=36). Data analysis employed Kaplan-Meier survival analysis, Cox proportional hazards models, ROC curve analysis, Fisher's exact test, and logistic regression using SPSS version 30.

Results Patients had a median age of 44 years (IQR: 31–50), with equal male-to-female ratios; most were diagnosed with acute myeloid leukemia (AML) and received Bu-Cy regimens. AUC groups were low (AUCcum <14,400 μM·min, n=13), in-target (14,400–24,000 μM·min, n=19), and high (>24,000 μM·min, n=4), showing significant differences in OS (p=0.002) and PFS (p=0.018). High- AUC patients had the lowest OS and PFS, while low- and in-target AUC groups achieved 100% 1- and 2-year OS rates and longer PFS trends. High AUC trended toward higher relapse risk vs. in- target (OR=5.143, 95% CI: 0.445–59.456, p=0.190), with elevated AUCcum significantly associated with mortality/disease progression (HR=1.000, 95% CI: 1.000–1.000, p=0.010), though not clearly impacting OS or relapse prediction. No significant associations emerged between busulfan exposure cutoffs (18,000, 22,000, 24,000 μM·min) and severe non- hematologic toxicity, mucositis, or hepatotoxicity.

Conclusion and Relevance Findings support that busulfan exposure exceeding the target range correlates with inferior survival and disease control outcomes, whereas low or in-target AUC levels trend toward superior results.

Background and Importance Patients with hematological and oncological diseases frequently receive vancomycin therapy, which is associated with substantial pharmacokinetic variability and toxicity. Model-informed precision dosing (MIPD) has been proposed to optimize vancomycin exposure and improve pharmacokinetic target attainment. A multidisciplinary MIPD intervention was introduced at a Swedish tertiary hospital in 2023 (1). This study aimed to evaluate intervention fidelity, feasibility in terms of time consumption and AUC24 target attainment during routine clinical use.

Materials and Methods The intervention was implemented at the Department of Blood and Tumor Diseases, Uppsala University Hospital, Sweden. Data was collected from electronic medical records (EMR), case report forms and MIPD software reports (InsightRx settings and estimated AUC24). Time expenditure related to MIPD activities was recorded by pharmacists and MIPD consultants.

Results A total of 42 vancomycin treatment courses (37 patients) and 215 therapeutic drug monitoring samples were evaluated. MIPD reports were available for 79% (169/215) samples. Among these, dose reduction was recommended in 30% (50/169), dose increase in 7% (12/169), unchanged dosing in 53% (90/169), and hold and/or additional sampling in 11% (18/169). Median (range) time from reported concentration to MIPD report was 2.4 (0.08–54.2) h, with 60% delivered within 3 h and 11% exceeding 16 h, mainly on weekends. Dose decisions were concordant with MIPD in 85% (144/169) of cases, with pharmacist involvement in 72% (121/169). Time recordings indicated MIPD consultants spent 3.4 ±3.8 min on data entry and 13.9 ±5.7 min on prediction and EMR documentation, while pharmacists spent 5.7 ±2.8 min on data entry and 12.4 ±9.1 min on participation in rounds and EMR documentation. Target attainment improved from 54% (23/42) prior to the first recommendation to 88% (113/129) after MIPD-guided dosing.

Conclusion and Relevance Implementation of vancomycin MIPD was feasible and contributed to improved pharmacokinetic target attainment in oncology and hematology patients. These results support precision dosing services to enable individualized antimicrobial therapy in cancer patients.

Background and Importance Manu al preparation of oncologics requires high forces to compensate the pressure differences of vials, primary packaging materials and syringes in coupled systems. This specific permanent load leads to injury of hands of the employees. Consequences are tendonitis, carpal tunnel syndrome and in worst case dislocation of hand bones generating high absence rates. In worst cases employees become unable to work in this sector. The usage of automation can relieve staff of manua l activities, protect them from substance contaminations and enhance safety of production process.

Materials and Methods Due t o it ́s compact design and the possibility to fil l bags, pumps and syringes, the Smartcompounder chem o® has been selected as ideal component for automation and could be integrated into the laminar flow working bench. The robot is connected by an interface to the software BD CATO®. Chemfort® from Simplivia is used as CSTD for all ́dosage activities guaranteeing a closed process. After adjusting of software and interface according to user requirements, the robot was implemented into the routine process after an det ailed validation.

Results Up t o now over 40 % of patient specific preparations could be transferred to the Smartcompounder Chemo®. Together with preparation of bags and syringes with dosage volumes over 5 ml, especially high demands of elastomeric pumps for oncologic and antibiotic therapies requiring high counterpressure for filling can be managed by the equipment without any problems. Sterile mediafills performed in an unclassified clean room zone could successfully prove the tightness of the system. Most of the containers could be filled with a gravimetric controlled dosage precision below ± 2 % which is tighter than the range of the manual preparation of ± 5 %. All components are identified by a barcode scanner avoiding any mix-ups. Since implementation of the system, the absence rates of staff due t o hand issues reached nearly zero. A new interesting technology improves the working place and takes employees out of the monotony of a manual sterile process.

Conclusion and Relevance The automation project reached all goals. Employees could be relieved by tranfer of production runs requiring high manufacturing pressures to the maschine. It was possible to integrate a safe process with identification of all components and high precision gravimetric dosing. Team satisfaction leveled of on the upper end of the scale. At the end the robot became a friend called “Roby ”.

Background and Importance Momelotinib is used in the treatment of splenomegaly or disease-related symptoms in adult patients with moderate to severe anemia who have primary myelofibrosis. A 78-year-old woman, diagnosed with high-risk myelofibrosis and proposed for third-line treatment with momelotinib, with a history of adverse reaction to hydroxyurea, developed an allergic reaction after taking momelotinib. The case was assigned to the Immunology and Allergology department to evaluate thet reaction and plan a desensitization protocol, given the lack of therapeutic alternatives.

Materials and Methods Research available articles regarding momelotinib desensitization protocols, momelotinib handling, and its physicochemical characteristics. The initial search found no articles on desensitization protocols, nor on the preparation of an oral momelotinib suspension. After extensive bibliographic research and contact with the drug manufacturer, we obtained no information regarding the possibility of preparing an oral suspension of momelotinib. Since there are no specific stability studies for the drug, we focused our research on various pharmacopoeias.

Results Since there are no specific stability studies for the drug, we focused our research on various pharmacopoeias in order to assign a shelf life for the oral suspension to be prepared (United States Pharmacopeia (USP); Bulletin by Spanish Society of Hospital Pharmacist (SEFH)). The only information available was that the tablets should not be crushed. Therefore, we attempted to dissolve them in water, which was successfully done. Since there were no articles on desensitization to this drug, the medical team designed a more conservative desensitization protocol, lasting 30 days, with increasing doses until a final dose of 100 mg was reached. Based on all the collected bibliography, a preparation sheet was developed, taking into account the dose to be administered to the patient and the shelf life assigned by the Spanish Society, which is more conservative.

Conclusion and Relevance The desensitization protocol was considered a success. The use of this protocol allowed for continuity of treatment with the established therapy in a patient with no therapeutic alternative. After the protocol was completed, the patient started a dose of momelotinib 100 mg, which she maintained until her death in December 2025.

Background and Importance For batch production of injectable anticancer drugs, the sterility test outlined in the European Pharmacopoeia (EP) is not well-suited to practical use. Automated CO2 growth detection systems providing rapid results are currently available. While alternative methods validated according to EP standards can be employed, practical applications are poorly detailed. This study presents the validation results of an alternative sterility testing rapid method (ARM) adapted for batch production of anticancer drugs in hospital pharmacy, in comparison to the direct seeding reference method (RM).

Materials and Methods The BD BACTEC® system was used for the ARM. The microbial strains tested were those recommended by EP as well as two commensal strains. Each strain was inoculated in triplicate with adapted CFU concentrations for the specificity, the equivalence, the detection limit and the applicability tests. Both monoclonal antibodies and cytotoxic drugs were used with negative controls. Vial positivity and time to detection (TTD) of strains were measured. A Student's t-test (two-tailed,α=5%) was used to compare TTD means. The Most Probable Number’s rule (IC95%) was used to estimate the limit of detection).

Results The ARM detected all the microbial strains in less than 48 hours during the specificity test, and reduced the mean TTD until 500% as compared to the RM. The equivalence test conduct to a non-inferiority of the ARM compared to the RM (p<0.05). The detection limit test conducted to set the limit of detection for both ARM and RM at approximately 1 CFU/mL. All the vials for Pembrolizumab, Trastuzumab, Bevacizumab, Nivolumab, Paclitaxel and Carboplatin showed growth for the entirety strains, validating their applicability tests. We observed a statistically significant variation in the TTD between few drugs and the positive controls (p < 0.05) indicating a statistically measurable effect of the drug on the growth of several strains. Both 5-Fluorouacil and Gemcitabine showed respectively 2/8 and 5/8 strains detected, invalidating their use without pre-processing. Negative controls remained negative. We did not observe any vial showing positivity in the ARM after the 5-days incubation period.

Conclusion and Relevance The tests carried out demonstrate that the BD BACTEC™ provides results comparable to those obtained with the method described in the EP, supporting the complete validation of its use for rapid sterility testing in 5 days. It is therefore validated for our pharmacy department to adopt this method for sterility testing of batch preparations for various anticancer in accordance with the EP.

Background and Importance Oncology pharmacy units are vital in providing physical and emotional support to cancer patients. Effective collaboration between pharmacists and physicians, as seen in practices like those in China, is crucial for delivering comprehensive care. Patient satisfaction is a key measure of healthcare quality. This study aims to evaluate cancer patients' satisfaction with oncology pharmacy services and assess the satisfaction levels of other healthcare and supportive staff working closely with the oncology pharmacy unit.

Materials and Methods This questionnaire-based qualitative cross-sectional study evaluated the best practices of oncology pharmacy services for patients and the efficiency of services provided by healthcare professionals and administrators at Benjamin Mkapa Hospital (BMH). The study was conducted from July to August 2022 at the adult oncology unit. It included all consenting patients and staff who attended or served in the unit and met the inclusion criteria during this period.

Results In two months, we assessed patient and staff satisfaction with oncology pharmacy services at the BMH oncology pharmacy. We collected responses from 62 patients and 53 staff members. Among the patients, approximately 86% expressed satisfaction with the overall care provided by the oncology pharmacy services, 79% were satisfied with the dispensing practices and pharmaceutical care, and 64% were pleased with the patient-pharmacy personnel relationship. The staff survey, conducted among those closely collaborating with the oncology pharmacy unit, revealed that 85% were satisfied with the unit's plan and mission, 72% were content with the teamwork and motivation of the pharmacy personnel, and 92% were satisfied with the competencies of the pharmacy staff.

Conclusion and Relevance Our study revealed high levels of satisfaction and acceptance of the services provided by pharmaceutical personnel for cancer patients. To enhance the quality and safety of these services, we recommend implementing additional training, establishing clear job descriptions, and ensuring direct involvement of pharmaceutical personnel in cancer treatment planning and follow-up.

Background and Importance Preparing chemotherapy drugs is a high-risk activity requiring extreme precision. Errors in dosage, dilution, or identification can have serious consequences for patients. In this context, we have developed a computerized system for preparing anticancer drugs, in order to implement it at Batna cancer hospital (CLCC de Batna).

Materials and Methods A spreadsheet-type tool was developed, integrating all the variables and information necessary for preparation : •Patient identification •Administration and infusion data •Drug characteristics : dosage, number of units, volume, reconstitution solvent, concentration, batch, expiration date •Automated calculations :volumes to be drawn, total and remaining volume •Operating procedure and storage and stability conditions Data relating to anticancer drugs were collected from references: SmPC, Stabilis®, 2013 CNIHM of cancer drug, The Algerien practical manual for nurses and pharmacy technicians

Results An integrated database lists more than 50 anticancer drugs with their standard dosages (e.g., Rituximab 500 mg, Cisplatin 50 mg, etc.). The system allows: • Automatic calculation of the dose to be administered based on body surface area and the prescribed dosage; • Dynamic generation of the volumes to be drawn and the dilutions to be prepared; • Complete traceability (preparation date, preparer, storage conditions, batches); • Administrative and medical information on a single record; This system also allows us to print the label and preparation sheet for each product preparation. The implementation of this tool has significantly improved the safety of the cytotoxic drug supply chain. It reduces the risk of human error related to manual calculations and transcriptions, thus facilitating the work of technicians and pharmacists, while ensuring better traceability and compliance with good practices.

Conclusion and Relevance This simple comprehensive tool meets quality and safety requirements and could serve as a model for other organizations. Therefore, a transition to a fully integrated business application is planned for the medium term.

Keywords: Cancer chemotherapy, Medication circuit, Security, Computerization, Preparation sheet, Label, Traceability

Background and Importance Targeted cancer therapies have substantially improved oncologic outcomes but are associated with heterogeneous and increasingly complex cardiovascular toxicity profiles. Older adults (≥70 years), often affected by multimorbidity and polypharmacy, remain under-represented in registration trials, limiting robust evidence on real-world cardiotoxicity in this growing population. Using data from the Italian National Pharmacovigilance Network (RNF), this study aimed to identify age-driven, class-specific cardiotoxicity phenotypes and explore their implications for cardio-oncology governance

Materials and Methods We performed a retrospective observational analysis of spontaneous reports of suspected cardiovascular adverse drug reactions recorded in the RNF up to November 2025. Eligible reports involved HER2-targeted therapies, BTK inhibitors, EGFR tyrosine kinase inhibitors and ALK tyrosine kinase inhibitors, with at least one cardiovascular event and complete demographic data. Events were grouped into clinically homogeneous macro-categories. Frailty proxies were age ≥70 years, age ≥80 years and ≥1 concomitant medication. Analyses were descriptive.

Results A total of 227 cardiovascular ADR reports met inclusion criteria. Median age ranged from 71 to 78 years across therapeutic classes; 66.7–85.7% of patients were aged ≥70 years and up to 29.9% were ≥80 years. Polypharmacy was documented in 33.3–76.9% of cases. HER2-targeted therapies (n=39) were predominantly associated with ventricular dysfunction and heart failure– like events. BTK inhibitors (n=174) showed a marked enrichment for atrial arrhythmias, particularly atrial fibrillation, occasionally complicated by severe outcomes. EGFR tyrosine kinase inhibitors (n=14) were characterized by ventricular dysfunction and QT prolongation, whereas ALK inhibitors (n=9) were mainly linked to bradycardia and conduction abnormalities. Advanced age and polypharmacy emerged as cross-cutting amplifiers of cardiovascular vulnerability. The class-specific phenotypic patterns observed support differentiated and risk- adapted surveillance strategies rather than uniform monitoring approaches.

Conclusion and Relevance This national pharmacovigilance analysis delineates distinct, age-driven cardiotoxicity phenotypes across major targeted therapy classes in a predominantly older and multimorbid population. Advanced age and polypharmacy act as structural modifiers of cardiovascular risk, underscoring the need for class-specific and age-adapted cardio-oncology pathways.

Background and Importance Cytotoxic drug reconstitution requires strict quality and safety standards. Repetitive tasks expose pharmacy technicians (PT) to musculoskeletal disorders (MSD). Cyclophosphamide (CP) reconstitution is frequently performed, lengthy and labour-intensive due to difficult dissolution, reducing efficiency and increasing work strain. Ready-to-use CP formulations contain ethanol, limiting their use in paediatric patients and individuals with aldehyde dehydrogenase 2 variants. A mechanical shaking device was introduced to optimize CP reconstitution.The study assessed productivity and PT satisfaction.

Materials and Methods Mean CP reconstitution time (min/vial) for manual (MR) and semi-automatic (SAR) was measured. PTs completed a 5-point Likert satisfaction questionnaire before and after shaker installation, assessing ease of use, time required, overall satisfaction and MSD risk prevention. Responses were analysed using Likert scores and presented as favourable (4-5) vs non- favourable (1-3). An additional question compared reconstitution before and after (superior, equivalent, inferior). Reconstitution time and satisfaction scores were compared using Mann- Whitney and Wilcoxon signed-rank tests.

Results In 20 reconstitution sessions per method, 33 vials were prepared in 71 min (1-4 vials/session) with MR vs 160 vials in 300 min (8 vials/session) with SAR. Reconstitution time decreased from 2.5 min/vial with MR to 1.9 min/vial with SAR (p=0.0029). Thirteen PTs (100% of unit staff) completed the questionnaire before and after installation. The proportion of PTs rating reconstitution ease as good increased from 8% before to 77% after (p=0.002). The proportion considering reconstitution time too long decreased from 100% before to 69% after (p=0.003). Measures to prevent MSD risks were considered sufficient by 15% before vs 54% after (p=0.002). Overall satisfaction increased from 0% to 69% after implementation (p=0.0002). After SAR, 85% considered the new process better and 15% equivalent. Before installation, PTs requested the implementation of a shaker; afterward they suggested optimizing tray height to improve vial stability and limit excessive movement.

Conclusion and Relevance The use of a shaker to facilitate CP reconstitution improved both productivity and PT satisfaction. However, technical improvements are still required to optimize its use in routine practice. We are currently working with the manufacturer to improve the device and plan to extend its use to other difficult-to-reconstitute drugs such as treosulfan.

Background and Importance Temozolmide (TMZ) is used to treat neuroblastoma and brain tumours, yet only capsules are available for oral therapy and paediatric formulations are still missing. In practice, capsules may be opened and mixed with food or processed into oral suspensions, potentially exposing health care workers or caregivers to the drug outside controlled environments. To address this risk, a TMZ suspension was developed and implemented in clinical practice, using a novel compounding approach in which capsules were wet-milled to produce a liquid formulation suitable for safe administration in young children.

Materials and Methods After a thorough literature search, a TMZ suspension 20mg/ml was prepared using a wet mill (WetMill Compact, FagronLabTM). This device can process whole tablets and hard capsules in a closed system without the need to grind or open them first. TMZ hard capsules were placed in the WetMill bottle together with preserved water (0,14% potassium sorbate), povidone K 25, sucralose and a strawberry flavour and wet-milled for 46 minutes. Syrspend® SF pH4 powder was added after the milling process, as wet-milling is more effective in low-viscosity media. Finally, the suspension was shaken vigorously.

Results Over one year of routine clinical use, the formulation proved feasible in practice and was prepared 38 times. Visual inspection consistently showed a homogeneous suspension that could be administered directly from the WetMill bottle. Routine preparation demonstrated that selecting an appropriate TMZ capsule strength is important, as low-dose capsules contain a higher proportion of excipients, resulting in an overly viscous suspension and requiring adjustment of the amount of Syrspend® SF pH4 powder. Due to the modified TMZ formulation and the absence of additional stability data, the shelf life of the final product was limited to 2 weeks at 2–8 °C. Therefore, a preparation volume of 50 ml was preferred to minimise the amount of unused product requiring disposal. No microbial growth or mold formation was observed in any preparation. The suspension was administered both orally and via a nasogastric tube. No handling difficulties or palatability issues were reported.

Conclusion and Relevance With increasing use of oral chemotherapy in paediatric patients, this compounding method enables safe preparation of liquid dosage forms until licensed products become available. As cytostatic drugs pose risks for caregivers, the approach improves safe handling and supports individualised therapy. Similar suspension formulations for antiviral and cytostatic drugs are currently under development.

Background and Importance Currently, dermal exposure represents the primary route of exposure to antineoplastic drugs, mainly through the transfer of contamination from work surfaces and non-specific materials. In addition, residues of anticancer agents present on the external surfaces of manufacturer- supplied vials constitute a frequently underestimated source of environmental contamination spread. The objective of this study was to evaluate the risk of occupational exposure among healthcare workers during the manual preparation of antineoplastic drugs.

Materials and Methods Failure Modes, Effects and Criticality Analysis (FMECA) was conducted by a multidisciplinary team. Failure modes were identified using an Ishikawa diagram, focusing on five key steps of cytotoxic drug preparation: packaging and handling, reconstitution, dilution, pharmaceutical form, and waste disposal. we adopted the Risk Priority Numbers (RPN) rating to establish an acceptable risk level (ARL). To calculate RPNs, failure modes were scored from 1 to 6, where 1 represented very low risk and 6 very high risk. ARL reflecting tolerable operational risk, ranged from 6 to 30.

Results Packaging handling, reconstitution and waste disposal were identified as the failure modes associated with the highest RPN (5,6,4 respectively) across all cytotoxic drugs. Among the products assessed, powdered antineoplastic drugs and those with high average therapeutic concentrations were associated with the greatest exposure risk (20 and 17). Pharmaceutical liquid cytotoxic drug available in a single concentration, also contributed to exposure risk, as they frequently require multiple dilution steps to achieve patient-specific doses. The proposed corrective actions focused on minimizing operator contact with cytotoxic drugs include the implementation of automated preparation systems and the segregation of waste materials generated during cytotoxic drug preparation.

Conclusion and Relevance Our study identified and prioritized potential weaknesses in cytotoxic drug preparation processes, enabling targeted interventions to enhance operator safety. In this context, automated preparation systems offer a promising strategy to further improve safety in hospital pharmacy compounding units.individualised therapy. Similar suspension formulations for antiviral and cytostatic drugs are currently under development.

Background and Importance Immersive technologies such as Virtual Reality (VR) and Augmented Reality (AR) are increasingly used in health professions education, providing safe, interactive, and standardized training environments. Studies have demonstrated significant improvement in technical and cognitive skills, particularly for procedural tasks. In oncology pharmacy, where chemotherapy validation and preparation demand high precision, immersive simulation may strengthen competency- based training and patient safety.

Materials and Methods A structured immersive scenario was designed using a modular approach aligned with competency-based education principles. Core oncology pharmacy competencies were defined, including prescription validation, dose calculation, aseptic preparation, and chemotherapy safety. The scenario included progressive modules with interactive decision-making sequences and embedded feedback, emphasizing repeatability, standardized tasks, and performance- oriented objectives, using standard AR/VR technology.

Results The designed scenario includes three interactive modules: Safety briefing: review of safety rules, virtual presentation of preparation materials, personal protective equipment, and good preparation practices for handling cytotoxic drugs. Prescription validation and preparation: simulation of order verification and chemotherapy handling, including control of volumes and concentrations. Interactive feedback and quiz: immediate feedback on correct and incorrect actions, complemented by an interactive quiz. This scenario allows unlimited repetition of procedures in a simulated environment, safe for patients, promoting hands-on learning, knowledge retention, and pharmacist engagement. It is implementable using standard AR/VR technologies and adaptable to different skill levels. The approach shows strong potential for pharmacist training, and future evaluations may assess how VR/AR learning translates to real-world practice.

Conclusion and Relevance The scenario while still in design phase, offers an innovative, safe, and flexible approach for oncology pharmacists. The scenario enhances competency, vigilance, and engagement, allows repeated practice in a risk-free environment, and can be integrated into professional training programs to support skills acquisition, mastery, and improved patient safety.

Background and Importance Epcoritamab, a CD3/CD20 bispecific antibody indicated for relapsed or refractory large B-cell lymphomas, is currently available in France via an early access program. Treatment initiation requires step-up dosing to reduce immune-mediated toxicities. The double dilution of the first doses mandated by the sponsor involves specific vials provided only for clinical trials and not supported by our prescribing software. Therefore, within the early access program, a direct syringe dilution was implemented in our center and its clinical safety and pharmaceutical relevance are assessed in this study.

Materials and Methods We conducted a retrospective single-center study including patients treated with epcoritamab in our institution since early access authorization. Data extracted from Chimio® prescribing software and Orbis® electronic medical records included, among others, demographic characteristics, prior therapies and documented toxicities occurring during the first weeks of therapy. Initial doses were prepared using direct syringe dilution according to a validated internal procedure implemented in our center. Outcomes were compared with published results from the EPCORE NHL-1 trial.

Results Overall, 39 patients received a first cycle of epcoritamab in our center from July 2023 to February 2026, with a mean age of 67 years. Most patients were male (64%) and had stage IV diffuse large B-cell lymphoma (67%) previously treated with two prior lines (range, 2–6); over 46% of them had received prior CAR-T cell therapy. Baseline characteristics were broadly comparable to those reported in trials. Cytokine release syndrome (CRS) occurred in 59% of patients during cycle 1, including 70% grade 1 events, with no grade ≥3 CRS observed. Neurological events consistent with immune effector cell-associated neurotoxicity syndrome were observed in 5% of patients and were low grade only. These results remained in line with previously published tolerability data. From an organizational perspective, direct syringe dilution reduced preparation time and costs associated with dedicated materials while enabling implementation of a standardized preparation procedure compatible with our software.

Conclusion and Relevance Our study suggests that direct syringe dilution of epcoritamab during the first cycle step-up dosing is a feasible and safe alternative in real-life clinical practice. While maintaining a safety profile comparable to published data, this simplified preparation approach provides clear organizational and economic advantages, compatible with everyday clinical practice and its requirements.

Background and Importance IV Workflow Management Systems (IVWMS) have been developed in recent years.These technological aids combine the qualitative and quantitative control maintaining the guidelines established in GMP ́s, facilitating the integration of technological quality controls during the preparation process, and generating traceability of all steps. (ASHP, 2025). The present work aims to know the level of adherence to the use of technology for assisted, safe and efficient preparation through qualitative and quantitative control of IVWMS called ePASE®a module of Farmis_Oncofarm® in hospitals in Ibero America.

Materials and Methods The main resources used in this study were the ePASE® module and the Data Analysis and Visualization module (AVIDA®) of Farmis_Oncofarm®. Observational study where data on the total number of antineoplastic preparations and the number of preparations compounded with the ePASE® module were obtained monthly from January 2024 to the end of 2025 for each hospital. We established a monthly contact and follow-up methodology with hospitals and in cases of a decrease in usability of ≥10%, the hospitals were contacted to identify the cause of non- adherence and give them support respect it.

Results During the study period, all the hospitals in study produced 1,877,367 antineoplastic mixtures, where 1,357,973 were made with ePASE® (72,3%). Regarding the adherence to this technology, defined as the number of antineoplastic mixtures prepared with ePASE® relative to the total number of antineoplastic mixtures prepared, yields an average value of 71,3% for 2024 and 77,8% for 2025.We observed an adherence greater for 50% in 80% of the hospitals (n=61) in 2024 and 84% of the hospitals in 2025 (n=65). Additionally, we obtained the average of queries per month for each hospital yielding 0,9 in 2024 and 0,6 in 2025. The sustained increase in adherence to the oncology preparation software, together with the progressive reduction in queries suggests greater user experience among professionals working with ePASE®, as well as continuous improvements of the tool. In particular, the introduction of an online virtual assistant since May 2025. We will further discuss the causes of non adherence.

Conclusion and Relevance The adherence to ePASE® technology was improved with the availability of support with specialized consultants, ongoing training, online virtual assistant and the personalized follow-up plans in case of incidences or queries. Beside to this, the multidisciplinary work between IT informatics, pharmacists and technicians was a key factor for the adherence of users in the use of this technology.

Background and Importance Acute lymphoblastic leukemia (ALL) is the most common pediatric cancer worldwide. It constitutes about 25–30% of all childhood cancers globally. Malnutrition is a frequent and modifiable determinant of treatment-related morbidity and mortality in pediatric cancers, particularly in low- and middle-income countries. This study evaluated the association between baseline nutritional status and induction-phase outcomes in children with acute lymphoblastic leukemia (ALL).

Materials and Methods An ambispective cohort study was conducted including children aged 1–18 years diagnosed with ALL between 2015 and 2024 at a tertiary care center in India. Baseline nutritional status was assessed using World Health organization (WHO) and Indian Academy of Pediatrics (IAP) criteria. Induction-phase outcomes included mortality, morphological remission, minimal residual disease (MRD) status, chemotherapy-related toxicities, and duration of induction therapy.

Results Of 200 enrolled patients, 61.5% were malnourished at diagnosis. Severe acute malnutrition was seen in 13.5% and Moderate Acute malnutrition in 18.92%, similarly grade III and grade IV had 8.5%(n=17) and 22.5%(n=45) malnutrition cases respectively. We found a statistically significant correlation (p=<0.001) between the poor nutritional status and mortalities, lower remission rates, increased febrile neutropenia, and prolonged induction duration (p < 0.001). Low serum albumin levels were also significantly associated with mortality (p = 0.009). our findings strongly advocate for comprehensive nutritional assessment and aggressive intervention strategies as an integral component of pediatric ALL management, especially in resource-limited settings like India. The observed high mortality rates, particularly among severely malnourished patients, coupled with diminished remission rates and compromised MRD negativity, underscore the critical impact of nutritional status on treatment outcome.

Conclusion and Relevance Baseline nutritional status significantly influences induction outcomes in pediatric ALL, with malnutrition correlating with increased mortality and poorer treatment responses. These findings underscore the critical need for comprehensive nutritional assessment at diagnosis and targeted interventions to improve prognoses in pediatric ALL patients, especially in resource- limited settings.

Background and Importance BrECADD is an effective frontline regimen for advanced-stage and unfavorable-risk classical Hodgkin lymphoma (cHL), but access to brentuximab vedotin is limited in resource-constrained settings due to high cost. Escalated BEACOPP remains an alternative; however, procarbazine is unavailable in Thailand. Consequently, dacarbazine has been substituted, resulting in the eBEACOPDac regimen. In real-world oncology pharmacy practice, regimen adaptation based on drug availability is essential, yet clinical outcome data for eBEACOPDac remain limited.

Materials and Methods A retrospective study was conducted at King Chulalongkorn Memorial Hospital, Thailand. Patients with classical Hodgkin lymphoma who received eBEACOPDac between January 2017 and December 2025 were included. Treatment consisted of either upfront eBEACOPDac (4–6 cycles) or ABVD for 2 cycles followed by eBEACOPDac (4–6 cycles). Regimen adaptation and medication management were performed in collaboration with oncology pharmacists. The primary outcome was progression-free survival (PFS).

Results A total of 41 patients were included. Sixteen patients received upfront eBEACOPDac, with no disease progression observed in 12 patients, corresponding to a PFS rate of 75%. Twenty-five patients received eBEACOPDac following initial ABVD, with no disease progression in 21 patients, yielding a PFS rate of 84%. Refractory disease occurred in three patients in each group. Overall, eBEACOPDac demonstrated consistent disease control regardless of treatment sequence. The observed PFS outcomes were comparable to those reported in the HD21 trial, acknowledging differences in study design and patient populations. A proportion of patients received consolidative radiotherapy, which may have contributed to favorable outcomes. Larger cohorts would enable stratified analyses, including the impact of radiotherapy, to improve the precision of outcome estimates.

Conclusion and Relevance The eBEACOPDac regimen demonstrates encouraging real-world outcomes in classical Hodgkin lymphoma and represents a feasible alternative to brentuximab vedotin–containing regimens in settings with limited drug access, supported by oncology pharmacist–led regimen adaptation and medication management. Further studies with larger sample sizes and longer follow-up are warranted.

Background and Importance Sotorasib (SOT) is a selective KRAS G12C inhibitor indicated non-small cell lung cancer (NSCLC) for previously treated patients with this molecular alteration. The objective is, to describe and to analyze the health outcomes according to effectiveness and safety of SOT in approved indication.

Materials and Methods Retrospective observational study conducted at oncology reference hospital. All NSCLC patients treated with SOT after progression following first-line treatment between November 2022 and January 2026 were included. The primary effectiveness variables were overall survival (OS) and progression-free survival (PFS) and progression-free survival after SOT therapy (PFS2), PFS and PFS2 were measured as time on treatment. Safety variable were incidence and SOT-related adverse events (AEs) as well as patient demographic variables. We perform frequency analysis and survival analysis.

Results The cohort included 8 patients (6 men). The mean age was 63 years (range: 52–70), with performance status ECOG 0-1 in 62% of patients and ECOG ≥2 at the rest. At the time of study closure, only one patient remained on treatment, the rest died. The median PFS on SOT treatment was 2.4 months (range: 0.3-16.3). The median OS was 3.7 months (range: 1.2-19.3). Four patients received subsequent lines of treatment with a median PFS2 of 5.2 months [range: 0.2-14.7]. One patient received clinical trial treatment after SOT and three patients received docetaxel; of these, one also received a platinum-based doublet. Seven patients (87.5%) experienced serious digestive AEs related to SOT, of which four required hospitalization. The main AEs were gastrointestinal (6 patients): diarrhea, vomiting, nauseas, hypertransamineemia and cholangitis, a patient abandoned SOT treatment. Four patients permanently discontinued SOT due to AEs, and in the remaining three the SOT dose was reduced.

Conclusion and Relevance The OS and PFS in our cohort were lower than those in the pivotal trial of SOT, with the best OS outcomes were at patients who received therapy after SOT. Digestive toxicity from SOT is the limiting AE for treatment duration and, therefore, for survival in these patients.

Background and Importance Tucatinib was approved in 2021 as a third-line treatment for HER2-positive metastatic breast cancer after the HER2CLIMB trial. The incorporation of trastuzumab deruxtecan (T-DXd) as preferred second-line therapy has changed the therapeutic sequence, creating uncertainty about tucatinib outcomes in patients previously treated with T-DXd. The aim of this study was to evaluate the effectiveness and safety of tucatinib in routine clinical practice, using the HER2CLIMB trial and other real-world studies as benchmarks.

Materials and Methods Retrospective observational study of patients with HER2-positive metastatic breast cancer treated with tucatinib, capecitabine and trastuzumab after two previous anti-HER2 lines between 2021 and September 2025. Demographic and clinical variables, metastatic sites, previous treatments, treatment duration, cause of discontinuation, tumour response according to RECIST 1.1, adverse events (AEs) and dose reductions were collected. Efficacy was assessed by progression-free survival (PFS) and overall survival (OS), obtained by the Kaplan-Meier method, and safety by AEs and dose reductions.

Results Twenty-six patients were included; mean age was 58 years (±9.8), 92.3% were women and 92.4% had ECOG (Eastern Cooperative Oncology Group) 0–1. Fifty-three point eight per cent were hormone receptor positive, and the most frequent metastatic sites were bone (65.4%), lung (42.3%), liver (42.3%) and brain (26.9%). The median number of previous metastatic lines was 2 (IQR 1.8–4.3), mainly trastuzumab–pertuzumab (92.3%) and T-DXd (88.5%). Treatment was discontinued mainly due to progression (86.4%), with a median duration of 4.9 months (IQR 2.8–6.3). The objective response rate was 19.2%, and 34.6% achieved stable disease. Median PFS was 5.1 months (95% CI 4.3–5.8) and median OS 13.6 months (95% CI 4.3–23.0). All patients experienced at least one AE, mainly digestive (84.6%), anorexia/asthenia (57.7%), palmar-plantar erythrodysesthesia (34.6%) and mucositis (19.2%). Fourteen patients required capecitabine dose reduction and six tucatinib.

Conclusion and Relevance The efficacy results observed in our cohort are lower than those described in the HER2CLIMB trial, but similar to those reported in other real-world series with more pretreated populations and high prior exposure to T-DXd. The safety profile was consistent with that described in the pivotal clinical trial.

Background and Importance The combination of atezolizumab and bevacizumab (ATE-BEV) has become a standard treatment for advanced hepatocellular carcinoma (HCC). Given the high cost and severity of the disease, it is essential to understand its real-world effectiveness and therapeutic positioning. This study aims to evaluate the effectiveness of ATE-BEV in patients with advanced HCC in routine clinical practice and to compare the findings with the efficacy data from the pivotal trial that led to its marketing authorization.

Materials and Methods A retrospective observational study was conducted, including all patients treated with ATE-BEV at standard doses between May 2021 and January 2026 for advanced HCC at a tertiary oncology referral center serving a population of approximately 600,000 inhabitants. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), duration of treatment (DT), and demographic characteristics such as age, sex, Child-Pugh score, performance status (ps), and HCC etiology. Kaplan–Meier analysis was used to estimate survival outcomes, and descriptive statistics

Results A total of 40 patients (90% male) were included, with a mean age of 64.0 years (SD = 8.84). Most patients had a good ps (ECOG 0: n=29; ECOG 1: n=9; ECOG 2: n=2). Child-Pugh class was A5–A6 in 72.5% of patients. Regarding etiology, 24 patients had non-viral HCC, 9 had HCV, and 7 had HBV. The mean dose of bevacizumab was 1,149 mg (SD = 237.1), atezolizumab was administered at a fixed dose of 1,200 mg in all patients. The median DT for the overall population was 3.7 months (95%CI: 2.6–4.4 m). The median overall survival was 11.7 m [95%CI: 5.3–18.0 m), and the median progression-free survival was 4.9 m [95%CI: 3.1–6.6 m). No significant differences in OS or PFS were observed according to ECOG, Child-Pugh or HCC etiology. Although not statistically significant, patients who received subsequent therapy after ATE-BEV (n=27) showed a trend toward longer OS compared to those who did not (n=13), with a median OS of 19.7 m (95% CI: 1.3–38.1) versus 5.9 m (95% CI: 0.0–12.6), p = 0.072.

Conclusion and Relevance The real-world effectiveness of ATE-BEV in our cohort was slightly lower than that reported in the IMbrave150 trial. This discrepancy may be explained by additional prognostic factors related to tumor characteristics, patient baseline status, or prior treatments not captured in this study.

Background and Importance Uveal melanoma (UM) is a rare type of ocular cancer with limited treatment options, characterized by its low sensitivity to chemotherapy, radiotherapy, and immunotherapy. Tebentafusp is the first drug approved for the treatment of metastatic UM in patients who are HLA-A*02:01 positive. The purpose of this study was to evaluate the efficacy and safety of tebentafusp in patients with metastatic UM who are HLA-A*02:01 positive in a real-world clinical setting.

Materials and Methods Retrospective, multicentre study including patients diagnosed with HLA-A*02:01 positive metastatic UM, treated with tebentafusp from 2022 to 2025. Data were obtained from the electronic medical record and the chemotherapy prescribing system, collecting demographic and clinical variables: sex, age, baseline functional status according to the Eastern Cooperative Oncology Group scale, prior lines of treatment, grade of adverse events according to the Common Terminology Criteria for Adverse Events, and radiological response according to the Response Evaluation Criteria in Solid Tumours.

Results Three patients with metastatic UM were included: two women (67 and 44 yrs) and one man (68 yrs), all with ECOG 0-1. Patient 1: diagnosed in 2019; tebentafusp was initiated in 2022 as third-line therapy following immunotherapy and chemotherapy. Developed grade 1 skin toxicity, no dose reduction was necessary. Progress after 5 months of treatment. Patient 2: diagnosed in 2017; tebentafusp was initiated in March 2024 after brachytherapy. Developed grade 3 skin toxicity from cycle 2, requiring dose reductions (68→30→20 μg), as well as infusion reactions, vitiligo, grade 1 dermatitis and dry eyes. The patient has maintained stable disease confirmed by PET-CT for more than 17 months. Patient 3: diagnosed in 2024. Started tebentafusp after brachytherapy in December 2024. Developed grade 3 cytokine release syndrome, later reduced to grade 1. Other adverse events were manageable. Initial pseudoprogression was followed by sustained clinical benefit, ongoing after 9 months.

Conclusion and Relevance Tebentafusp demonstrated sustained clinical benefit in two patients with metastatic uveal melanoma. The observed safety profile was consistent with published evidence, with manageable and reversible toxicities. Larger sample sizes and long-term data are required to determine its impact on overall survival.

Background and Importance Inflammation drives cancer progression, and platelets contribute to immune evasion and tumour growth. The platelet–lymphocyte ratio (PLR) has been proposed as a prognostic biomarker in immunotherapy-treated cancers. In non-small cell lung cancer (NSCLC), high baseline PLR has been associated with poorer overall survival (OS) and progression-free survival (PFS). This study aimed to evaluate the prognostic role of PLR and its dynamics during treatment in patients with locally advanced NSCLC treated with durvalumab after chemoradiotherapy.

Materials and Methods Retrospective observational study of locally advanced NSCLC patients treated with durvalumab (October 2017-September 2024). Collected variables: demographics, stage, histology, Eastern Cooperative Oncology Group performance status (ECOG PS), discontinuation cause, and dates of progression/death. PLR (platelet/lymphocyte) was assessed at baseline, week 4, and at the first imaging. Effectiveness outcomes: response rate, PFS, and OS. Survival was estimated with Kaplan–Meier and compared by log-rank; predictors were evaluated with Cox regression. ROC curves defined PLR cut-offs at each time point.

Results Fifty patients were included (80% male; mean age 62.8±7.9 years). At diagnosis, 54% were stage IIIB, 22% stage IIIC, 20% stage IIIA and 58% had ECOG PS 1. Adenocarcinoma and squamous histology accounted for 44% in both cases. At the data cut-off (December 2025), 19 patients were alive and 11 had not progressed. Durvalumab was completed by 38%; discontinuation occurred due to progression (36%), clinical deterioration (6%), or toxicity (20%). Median PFS and OS were 14.5 months (95% CI: 4.7–24.3) and 50.4 months (95% CI: 27.3–73.5), respectively. PLR cut-offs were 338.09 (baseline), 299.35 (week 4), and 150 (first radiological evaluation). In univariate analyses, PLR was significantly associated with PFS at baseline (p=0.007), week 4 (p=0.001), and first radiological evaluation (p=0.028). In multivariate analysis, only a PLR at week 4 <299.35 remained an independent predictor of longer PFS (HR=0.33; p=0.002), with a median of 22.1 versus 5.5 months.

Conclusion and Relevance PLR at week 4 after starting durvalumab was independently associated with PFS, while no association was observed with OS. Early assessment of PLR could provide a simple and accessible biomarker to stratify the risk of early progression.

Background and Importance Patients with relapsed/refractory multiple myeloma (RRMM) triple-class exposed have historically shown poor outcomes. Recently approved bispecific antibodies (BsAb), including teclistamab and talquetamab, have demonstrated promising efficacy in phase II trials. However, real-world effectiveness data remain limited. The aim of our study was to describe baseline characteristics of RRMM patients treated with BsAb in clinical practice and to evaluate treatment effectiveness in this setting.

Materials and Methods A retrospective observational study was conducted including RRMM patients treated with teclistamab or talquetamab in routine clinical practice between 2022 and 2025. Inclusion criteria were patients receiving BsAb outside clinical trials. Patients treated with BsAb as bridging therapy to chimeric antigen receptor T-cell (CAR-T) therapy were excluded. Clinical data were extracted from electronic health records and the onco-hematology software Farmis- Oncofarm®. Effectiveness outcomes included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS)

Results A total of 18 patients were analyzed: Eighteen triple-exposed RRMM patients were included; 12 received teclistamab and 8 received talquetamab. Two patients received sequential treatment with both BsAb antibodies. Median age was 78 years (58–86). . ISS stage was I 6%, II 22%, III 61% (11% unknown). High-risk cytogenetics were present in 44.5% (44.5% unknown). Median number of prior treatment lines was 4 (3–6); 72% were triple-refractory and 25% had received prior CAR-T or bispecific antibody therapy. Treatment with BsAb achieved an ORR of 84.2%, including a complete response (CR) rate of 52.6%. Median PFS was 11.1 months (95% CI: 5.5–NA), and median OS reached 31.3 months (95% CI: 20.3–NA). Treatment with teclistamab and talquetamab achieved response rates and survival outcomes comparable to those described in clinical trials, supporting their applicability beyond controlled study settings.

Conclusion and Relevance Patients treated in real-world clinical practice were heavily pretreated compared with populations included in pivotal clinical trials. Our outcomes are consistent with efficacy results reported in pivotal studies despite greater treatment exposure and clinical complexity. BsAb represent an effective therapeutic option for triple-class exposed RRMM patients.

Background and Importance Lung cancer remains a leading cause of cancer-related deaths globally, with non-small-cell lung cancer (NSCLC) accounting for 85% of all cases. Despite advancements in treatment, survival rates for advanced NSCLC remain low. Monoclonal antibodies such as nivolumab and pembrolizumab, while effective in enhancing the immune response against cancer, are linked to immune-related adverse events (irAEs). This study aimed to compare irAEs between nivolumab- pembrolizumab as first-line treatments for advanced NSCLC using real-world data from a single- center cohort in Kosovo.

Materials and Methods A total of 51 patients diagnosed with NSCLC and treated with nivolumab or pem-brolizumab in the Department of Oncology at the University Clinical Center of Kosovo between January- December 2023 were included in this prospective cohort study. Patients completed a previously validated and standardized questionnaire reporting potential irAEs during each treatment session.

Results Showed that the incidence of all-grade adverse events was similar between nivolumab and pembrolizumab, with a 14% onset of adverse event reporting. Endocrine toxicities, including hypothyroidism, were more frequent and associated with improved survival, while gastrointestinal toxicities such as abdominal pain, frequent defecation were more frequently reported in patients receiving nivolumab (p < 0.05). Pembrolizumab caused more frequent dry skin (p < 0.01). Pulmonary and neurological effects showed similarities between the treatments, however, nivolumab caused a significant increase in mucosal secretions (p < 0.05).

Conclusion and Relevance This study notes the association between nivolumab or pembrolizumab administration and the incidence of irAEs in patients with NSCLC. While immune checkpoint inhibitors have transformed the management of NSCLC, further exploration is necessary to un-derstand how NSCLC influences the development, severity, and outcomes of irAEs.

Background and Importance Pembrolizumab monotherapy has become the standard of care for patients with previously untreated metastatic non–small cell lung cancer (mNSCLC) and PD-L1 expression >50%. Although current guidelines endorse a fixed dose of 200 mg, pharmacokinetic and modeling studies have demonstrated no clear dose–exposure–response relationship for efficacy, showing that 200 mg and 2 mg/kg provide similar drug exposure. The aim of this study was to compare the effectiveness of two pembrolizumab dosing regimens in patients with mNSCLC, as well as to evaluate the reasons for treatment discontinuation.

Materials and Methods A multicenter, retrospective cohort study was conducted including patients with mNSCLC treated with pembrolizumab monotherapy as first-line therapy. Patients were categorized into two groups according to the dose received: standard dose (STD group, ≤2 mg/kg) and high dose (HD group, >2 mg/kg). Progression-free survival (PFS) and overall survival (OS) were assessed, as well as the reasons for treatment discontinuation. Statistical analyses were performed using Kaplan-Meier survival curves and Cox proportional hazards regression models.

Results A total of 98 patients were included, with a median age of 66 years (range, 40-81) and 75% were male. Most patients (73%) had adenocarcinoma. Baseline demographic and clinical characteristics were comparable between groups. The median number of pembrolizumab cycles administered was 16 (range, 2-75) in the STD group and 8 (range, 2-37) in the HD group. The median dose was 2 mg/kg (range, 1.69-2.17) in the STD group and 2.86 mg/kg (range, 2.22- 4.55) in the HD group. Median PFS was 13.8 months in patients receiving 2 mg/Kg and 7.3 months in those receiving >2 mg/Kg (HR 1.37; 95% CI 0.78-2.40; p=0.275). Median OS was 26.1 and 12.5 months for patients STD group and HD group respectively (HR 1.12; 95% CI 0.68-1.85; p=0.659). Most patients (71.8%) discontinued treatment due to disease progression (75% in the STD group and 68% in the HD group). Discontinuation due to adverse events was similar in both groups (12.5%).

Conclusion and Relevance In a real-world setting, our study showed similar effectiveness outcomes in patients with mNSCLC treated with 2 mg/Kg of pembrolizumab compared with higher doses, with no differences observed in the reasons for treatment discontinuation. These findings support dose optimization srategies.

Background and Importance Zolbetuximab is a chimeric monoclonal antibody targeting Claudin 18.2, indicated in combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with high Claudin 18.2 expression. Given its recent approval and limited access in our country, the aim of this study was to describe the real- world clinical experience with zolbetuximab in routine hospital practice.

Materials and Methods A retrospective observational study was conducted including patients treated with zolbetuximab at our hospital between April and December 2025. The variables collected were: demographic data (sex, age), diagnosis, Claudin expression, treatment regimen, number of zolbetuximab cycles received, effectiveness (progression-free survival [PFS], and radiological response [RECIST criteria]), and safety (adverse events). Data collection was performed using the hospital’s electronic medical record system. Statistical program used was SPSS® v21, calculated by Kaplan-Meier method.

Results A total of 5 patients were included (60% women), with a median age of 68.5 years (44–78). Of these, 80% were diagnosed with gastric adenocarcinoma and 20% with GEJ adenocarcinoma. Claudin expression was 80% in two patients, one patient showed 100% expression, one 95%, and one 75%. Zolbetuximab was administered in combination with fluorouracil, folinic acid and oxaliplatin in 80% of patients and with capecitabine and oxaliplatin in 20%. Median number of cycles received was 6. Median PFS was 6.53 months. At data cut-off, two patients remained on treatment with partial response, two patients had died, and one patient had switched to a subsequent treatment line due to disease progression. All patients experienced at least one of the following symptoms: nausea (100%), asthenia (100%), vomiting (80%), dyspepsia (80%), and decreased appetite (60%). Other adverse events not described in the Product Characteristics were diaphoresis (20%) and dysgeusia (20%).

Conclusion and Relevance In our real-world experience, zolbetuximab showed lower effectiveness than reported in pivotal trials, highlighting the importance of real-life studies. The safety profile was consistent with published data, with gastrointestinal toxicity being frequent but manageable. The oncology pharmacist plays a key role in the appropriate use of this innovative therapy.

Background and Importance Trastuzumab deruxtecan (T-DXd) is a HER2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, with demonstrated efficacy in multiple HER2-expressing malignancies, including breast, gastric and lung cancer. Its clinical development has expanded the therapeutic landscape for HER2-positive and HER2-low tumours. Despite strong clinical trial evidence, real-world data remain limited. This study aimed to evaluate the effectiveness and safety of T-DXd in routine clinical practice at our institution.

Materials and Methods We conducted a retrospective observational study including all patients treated with T-DXd at our hospital until January 2026. Collected variables included demographics (sex, age), tumour type, HER2 status, ECOG performance status, number of prior treatment lines, number of T-DXd cycles, effectiveness (progression-free survival [PFS], and radiological response [RECIST criteria]), and safety (assessed according to treatment-related adverse events). Data were sourced from our hospital’s electronic medical record system and statistical analysis was performed using SPSS®-Statistics v21.

Results 23 patients were included: 78.3% female; median age 63 years(44–86). Metastatic breast cancer(n=18): 89% invasive ductal carcinoma. 66.6% HER2-positive, 33.3% HER2-low. ECOG 0(16.6%), 1(72.2%) and 2(11.1%). Median prior lines 1.5. Median of 6.5 cycles received. Median PFS: 10.47 months (95%CI: 3.34-17.60). At data cut-off, 10 were alive: 8 remained with T-DXd (37.5% complete response, 62.5% stable disease), 2 discontinued for progression. Advanced HER2-positive gastric cancer(n=4): Received T-DXd second-line. ECOG 0(25%) and 1(75%). Median of 6 cycles received. Median PFS: 3.13 months(IC95%: 0–6.27). All died. 1 patient(ECOG 2) with metastatic HER2-positive colorectal cancer received off-label T-DXd fifth-line and discontinued after 2 cycles due to progression. Adverse events were asthenia 78.3%, nausea 56.5%, diarrhoea 34.8%, anaemia 34.8%, vomiting 30.4%. Dose reductions were required in 7 due to asthenia and haematological toxicity. 1 developed pneumonitis requiring treatment delay.

Conclusion and Relevance In our real-world cohort, T-DXd demonstrated clinical activity consistent with published trial data, particularly in breast cancer. Toxicities were frequent but manageable, with dose modifications required in some cases. This study supports the use of T-DXd in routine clinical practice, although outcomes appeared less favourable in heavily pretreated gastric and colorectal cancer patients.

Background and Importance Immune checkpoint inhibitors have significantly improved the prognosis of lung cancer. However, effectiveness observed in real-world clinical practice may differ from that reported in clinical trials due to differences in patient selection, adherence, comorbidities, etc. The aim of this study was to describe baseline characteristics and effectiveness outcomes (progression-free survival [PFS] and overall survival [OS]) of patients treated with atezolizumab or durvalumab at a tertiary hospital, and to compare with the respective trials: IMpower133 and Pacific.

Materials and Methods Retrospective study was conducted from january 2018 to july 2025. All patients treated with durvalumab or atezolizumab were included. Variables collected: age, sex, indication, treatment, treatment start and end date, reason for treatment discontinuation, date of disease progression, and date of death. Median PFS and OS (95% confidence Interval [CI95]) were estimated non- parametrically (Kaplan–Meier). To compare with clinical trials, an unadjusted comparison was performed between the medians observed in our study and those reported in the clinical trials using a two-tailed Waltz Test.

Results 44 patients were included: 18 in atezolizumab group and 26 in durvalumab group. Median age was 64.5 years (standard deviation[SD] 9.88) in atezolizumab group and 64.5 years (SD 7.24) in durvalumab group. Male patients were 77.8% and 69.2%, respectively. In our center, the atezolizumab group had a median PFS of 5.13 months (CI95: 4.0–18.2 months) and a median OS of 6.7 months (CI95: 4.4–13.7 months). No significant difference in PFS was observed compared with IMpower133 (5.2 months; p=0.971), whereas OS was significantly lower than that reported in the trial (12.3 months; p<0.001). In the durvalumab group, median PFS was 14.5 months (CI95: 10.5–60.7 months) and median OS was 23.7 months (CI95: 15.1–not reached). Significant differences were observed compared with the PACIFIC trial, which reported a median PFS of 16.9 months and a median OS of 47.5 months, p-value 0.013 and <0.001 respectively.

Conclusion and Relevance In this real-world cohort, significant differences in PFS and OS were observed compared with pivotal clinical trials, with generally shorter survival outcomes. The only exception was PFS in atezolizumab group. Further studies are needed to better define the effectiveness of these therapies in real-world populations.

Background and Importance The introduction of rituximab biosimilars has expanded access to biologic therapies for B-cell lymphoid malignancies while reducing treatment costs. Although several studies have demonstrated comparable safety and efficacy to the reference product, real-world evidence from Latin America remains limited. The primary objective of this study was to evaluate the safety of administering rituximab biosimilars interchangeably with the reference product. Secondary objectives included assessing treatment effectiveness in patients with diffuse large B-cell lymphoma (DLBCL) receiving first-line R-CHOP.

Materials and Methods We conducted a retrospective observational study including adult patients with B-cell lymphoid malignancies who received at least one dose of intravenous rituximab biosimilar between October 2020 and October 2022 at a public terciary hospital in Chile. Adverse events were classified according to CTCAE v5.0. Effectiveness was evaluated in a subgroup of patients with DLBCL treated with first-line R-CHOP using overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Survival curves were estimated using the Kaplan–Meier method.

Results A total of 152 patients were included. The mean age was 57.2 years and 53.3% were male. Forty- one patients (27.0%) experienced at least one adverse event during treatment, most of which were grade 1–2. In the DLBCL subgroup (n=50), the ORR was 76%, including 58% complete responses and 18% partial responses. PFS at 24 months was 62% (95% CI 47.1–73.8) and OS at 36 months was 65.8% (95% CI 50.9–77.2). Median PFS and OS were not reached. In this real- world study, the safety profile is consistent with previous reports for rituximab and its biosimilars, where infusion-related reactions occur in 20–40% of patients and are generally manageable. In the subgroup of patients with DLBCL treated with first-line R-CHOP, the

Aim and Objectives response rate (ORR) was 76%. Although slightly lower than that reported in prospective studies such as REFLECT, this difference may be explained by variations in baseline patient

Conclusion and Relevance The results of this study show that the use of rituximab biosimilars in patients with B-cell lymphoid malignancies in a Chilean public hospital demonstrates a favorable safety profile and effectiveness comparable to that reported in the literature. These findings support the safe and interchangeable use of rituximab biosimilars in routine clinical practice.

Background and Importance HER2-low (IHC 1+ or 2+/ISH-negative) tumours, previously labelled HER2-negative, are common in HR+ metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) improves PFS/OS versus chemotherapy and is guideline-positioned after progression on endocrine therapy (ET) plus iCDK4/6 and ≥1 chemotherapy line. However, data from routine clinical practice regarding outcomes and toxicity, remain scarce and heterogeneous. The aim of this study was to describe PFS, OS and safety profile and discontinuations of T-DXd in HR+, HER2-low mBC treated after progression on ET plus iCDK4/6 and chemotherapy.

Materials and Methods Single-centre retrospective observational study at Hospital Virgen del Rocío. Adults with HR+, HER2-low mBC treated with T-DXd in routine practice were included from first local authorization (Jun 2023) to discontinuation/death (cut-off 02/26). Data were retrieved from DIRAYA (demographics, ECOG-PS, metastatic sites, prior lines and AEs). Primary endpoint: Progression Free Survival (PFS). Secondary endpoints: Overall Survival (OS) and safety (CTCAE ≥G3 AEs, toxicity discontinuation, pneumonitis). PFS/ OS were estimated using the Kaplan Meier method; data collected and analysed in SPSS.

Results 41 women with HR+, HER2-low mBC received T-DXd; mean age was 60.9±11.5 years; ECOG 0 -1 83%, 2 in 14,6% and 3in 2.4%. HER2 status was IHC 1+ in 47.5% and IHC 2+/ISH− in 52.5%; we found ER+PR in 77.5% (ER-only 22.5%). Ki-67 was >20% in 47.5% (n=40). Median follow-up was 14.16 months (reverse Kaplan–Meier). Patients were heavily pretreated (median 5 prior systemic lines overall; median 4 in the metastatic setting), and 97.6% had prior CDK4/6 inhibition (mostly 1L–2L). Metastatic burden was frequently multi-site (56.1%), with bone as the most common single category (24.4%). The median PFS and OS were 10.73 months (95% CI 8.83–12.64) and 21.47 95% CI (4.97–37.97) respectively. In regard to safety,: 8/41 (19.5%) had grade ≥3 AEs, mainly neutropenia and asthenia (each 3/8; 37.5%). One patient (2.4%) developed fatal T-DXd–related pneumonitis; other pulmonary events were grade 1

Conclusion and Relevance T-DXd showed meaningful activity in real-world HR+, HER2-low mBC (mPFS 10.73 mo), broadly consistent with trials. OS (21.47 mo) is imprecise due to immature follow-up. Toxicity was manageable but not directly comparable (poorer ECOG, heavier pretreatment, retrospective AE capture); ILD requires close surveillance for timely detection. Further robust real-world evidence is needed.

Background and Importance Targeted therapies have significantly transformed cancer treatment by selectively inhibiting molecular pathways involved in tumor growth. Drugs targeting pathways such as the EGFR gene pathway or the HER2 gene receptor have improved survival outcomes in several malignancies. However, clinical data on the effectiveness and tolerability of targeted therapies remain scarce in Sub-Saharan Africa, including Mauritania. Evaluating treatment outcomes in real-world clinical settings is essential to better understand how these therapies perform in local populations.

Materials and Methods A retrospective observational study was conducted using medical records from patients treated between 2024 and 2025 at the National Oncology Center in Nouakchott-Mauritania. Patients receiving targeted therapies including: • Trastuzumab • Sunitinib • Pazopanib • Erlotinib were included. Data collected included: • patient age • sex • cancer type • treatment duration • therapeutic response • treatment-related adverse events Treatment effectiveness was evaluated using objective response rate (ORR) and progression- free survival (PFS).

Results A total of 96 patients were included in the analysis. Distribution by cancer type: • Breast cancer: 42 patients (44%) • Renal cell carcinoma: 27 patients (28%) • Non-small cell lung cancer: 27 patients (28%)

The overall response rate varied according to tumor type: • Breast cancer treated with trastuzumab: 48% response rate • Renal cell carcinoma treated with tyrosine kinase inhibitors: 41% response rate • Lung cancer treated with EGFR inhibitors: 36% response rate

Adverse events were reported in 57% of patients, most commonly: • fatigue • hypertension • dermatologic toxicity Severe adverse events (grade 3) occurred in 14% of patients, leading to treatment discontinuation in 9% of cases. Older patients (>60 years) experienced higher toxicity rates compared to younger patients.

Conclusion and Relevance Targeted therapies demonstrated clinically meaningful activity in patients treated at the National Oncology Center in Nouakchott. However, variations in treatment response and tolerability were observed depending on cancer type, age, and sex. This study highlights the importance of generating regional clinical data in African populations to optimize treatment strategies.

Background and Importance Neuroblastoma is the second cause of cancer related death in children. Dinutuximab, a monoclonal antibody targeting the disialoganglioside GD2 as maintenance therapy, has shown a significant survival benefit and is the standard of care. This study evaluated the effectiveness and safety of dinutuximab in paediatric neuroblastoma in clinical practice and compared the results with those of the pivotal trial.

Materials and Methods This retrospective observational study included paediatric patients treated with dinutuximab between November 2016 and April 2025, as first-line therapy for high-risk disease or in relapse/refractory setting. Variables collected: sex, age, stage, response after induction, and treatment-related variables (dates, number of cycles, and reason for discontinuation) Effectiveness was assessed by event-free survival (EFS) and overall survival (OS) using Kaplan– Meier method, and safety by adverse events (AEs) graded according to CTCAE. Statistical analysis was performed with SPSS statistics software.

Results Twenty-seven patients were included (median age 3 years, IQR 2–4; 70.4% male). Most had advanced-stage disease (92.6%), and 85.3% achieved complete response after induction. Treatment completion rate was 88.9%, with 7.4% discontinuing due to progression and 3.7% due to toxicity.

Among 24 patients receiving dinutuximab as first-line consolidation (median 5 cycles), 3-year EFS was 72.0% (95% CI: 52.8–91.2) and 5-year OS 73.0% (95% CI: 52.2–93.8) vs 55.4% and 65% in the trial. Three patients treated at relapse (median 8 cycles, IQR 5–8) combined with topotecan–temozolomide (n=2) or irinotecan–temozolomide (n=1) achieved 2-year EFS 66.7% (95% CI: 13.4–100%) and OS 100% vs 31% and 69%; one has died and two are still alive.

Infectious toxicities—mainly fever—were most frequent (85,2%), followed by haematological toxicity (63.0%) and neuropathic pain, gastrointestinal and cutaneous toxicities (59.3% each). AEs were grade 1–2 (67.5%), while 27.9% were grade 3 and 4.5% were grade 4.

Conclusion and Relevance Dinutuximab showed slightly higher effectiveness in paediatric neuroblastoma, with survival outcomes exceeding pivotal trials and a manageable safety profile. Most AEs were mild to moderate and a low discontinuation rate. However, the small sample size and retrospective design limit the strength of the conclusions, and larger prospective studies are needed to confirm these findings.

Background and Importance Treatment options are scarce in metastatic urothelial carcinoma (mUC) following progression after platinum chemotherapy and PD-1/PD-L1 inhibition. Enfortumab vedotin (EV) is a Nectin-4– directed antibody–drug conjugate delivering monomethyl auristatin E (MMAE) and is indicated as monotherapy for adults with mUC previously treated with platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor. The aim of this study was to describe the real-world effectiveness and safety profile of EV, and to contextualize results against pivotal trials.

Materials and Methods Single-centre retrospective observational study at Hospital Virgen del Rocío. Adults with mUC treated with EV were included from Jan 2024 to discontinuation/death (cut-off 22/02/26). Data was retrieved from DIRAYA: demographics, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS), tumor localization, prior lines and adverse events (AEs). Primary endpoint: Progression Free Survival (PFS). Secondary endpoints: Overall Survival (OS) and safety (CTCAE ≥G3 AEs, toxicity discontinuation). PFS/ OS were estimated using the Kaplan Meier method; data was collected and analysed in SPSS.

Results 42 patients (85.7% men) with mUC received EV; mean age was 69.95±11.8 years; ECOG 0-1: 95.1% and ECOG 2 4.87%. Almost 63% of patients had a vesical tumor, 37.2% had an urotelial tumor, and 13 patients (30%) had developed hepatic metastasis. Median follow-up was 10.19 months (reverse Kaplan-Meier).

The median PFS and OS were 3.51 months (95% CI 1.81-5.18) and 7.32 months (95% CI 5.41- 8.94) respectively. In regard to safety, 7 patients (16.67%) underwent one level of dose reduction according to the summary of product characteristics, 5 patients (11.9%) underwent two levels of dose reduction and 2 patients (4.76%) underwent three levels of dose reduction. The most common AEs were gastrointestinal symptoms in 22 patients (48.8%), asthenia in 20 patients (44.4%) and neurotoxicity in 19 patients (45.2%). In total, 7 patients (15.9%) developed grade ≥3 AEs.

Conclusion and Relevance EV constitutes a new therapeutic option in mUC after progression to the current standard of care. In our real-world population, PFS and OS were inferior in comparison with the pivotal trial; however, this data is imprecise due to immature follow-up. Toxicity was common, although manageable, and most AEs were mild to moderate in intensity. Further robust real-world evidence is needed.

Background and Importance Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia (PPE), is a cutaneous reaction relatively frequently observed with certain anticancer treatments. Although HFS is not life-threatening, it can be very painful, interfere with daily activities, and significantly impact the patients' quality of life. This study aims to determine the prevalence of HFS and identify the risk factors associated with its onset.

Materials and Methods This is a cross-sectional descriptive study conducted in the oncology departments of the Salah Azaiz Institute (Tunis, Tunisia). All patients receiving a chemotherapy cycle with a molecule susceptible to causing hand-foot syndrome were included. Data were collected via a questionnaire. Data processing and analysis were performed using SPSS software.

Results Ninety-eight patients were included in the study, with a female-to-male sex ratio of 1.4. The mean age was 58 ± 8.36 years. Patients were divided into two age groups: under 65 years and 65 years or older. The majority of patients (74.5%) were under 65. The molecules identified as being involved in the onset of HFS were 5-FU, Cytarabine, and Docetaxel. The most frequently prescribed protocols were Docetaxel (44.8%) and FOLFOX (34.6%), followed by FOLFIRI (12.2%). The prevalence of HFS was estimated at 22.2%. Management or specific care for HFS was noted in only 59% of cases. Univariate analysis of risk factors showed an association between the chemotherapy protocol (p=0.015), marital/family status (p=0.043), and education level (p=0.05). Multivariate analysis showed a significant association with family status (OR = 10.661, p=0.012, CI = [1.667–68.193]). Single status was identified as a risk factor.

Conclusion and Relevance The prevalence of HFS is significant (22.2%); however, its management is not systematic. Patients without strong family support are at a higher risk of developing HFS than others. Greater focus on the quality of life for patients affected by HFS is necessary.

Background and Importance Ipilimumab plus nivolumab improves survival in advanced renal cell carcinoma but is associated with a high incidence of immune-related adverse events (irAEs), often leading to treatment interruption. Early detection and multidisciplinary management are essential. Hospital pharmacists play a key role in toxicity monitoring and optimization. This study aimed to characterize the incidence, type, severity, and management of severe irAEs in real-world clinical practice.

Materials and Methods A single-center retrospective observational study included renal cancer patients treated with ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) between January 2021 and December 2025. Data were retrieved from electronic health records. Variables included demographics, disease stage, treatment line, number of cycles, and ECOG status. Adverse events were graded using CTCAE v5.0. Toxicity grade, time to onset, management, and hospitalizations were analyzed. Results are presented as median (IQR).

Results Forty-eight patients were included (77.1% male; median age 65 [58–71] years; median weight 76 [63–82] kg). Most had stage IV disease and received first-line treatment. Median cycles administered were 3 (2–4) and median ECOG was 1 (0–2). Overall, 56.25% (n=27) developed irAEs and 39.58% (n=19) experienced ≥3 toxicity comprising hepatitis (n=6), diarrhea and nephritis (n=3 each), pneumonitis and myocarditis (n=2 each), and polyradiculopathy, polyarthritis and adrenal insufficiency (n=1 each). The median time to onset of severe irAEs was 6 weeks (4–10). Nineteen patients required corticosteroids and 1 required infliximab. Treatment interruption occurred in 19 patients due to irAEs; 6 patients switched to nivolumab monotherapy and 13 underwent regimen changes. Nineteen hospitalizations were recorded. Most events resolved with immunosuppressive therapy, with no treatment-related deaths. Limited by retrospective, single-center design and small sample size, which may reduce generalizability.

Conclusion and Relevance In real-world practice, ipilimumab–nivolumab causes a high rate of severe irAEs, often requiring immunosuppression and treatment changes. These results highlight the need for proactive monitoring, early intervention, and multidisciplinary management. Hospital pharmacists play a key role in detection and management. Multicenter studies are needed to validate and optimize pharmacist-led strategies.

Background and Importance Oral methadone, as μ- and δ-opioid agonist, and due to its NMDA receptor antagonism, has been reported to be very effective in opioid switching. Intra-venous methadone (IV M) may be initiated when analgesic control remains insufficient (complex and refractory cancer pain) or when oral administration becomes limited. Evidence describing real life outcomes of switching from oral to IV M in palliative care oncology is limited. We aimed to determine profile of patients, safety and respect of recommendations treated with IV M in cancer patients in a real world hospital setting.

Materials and Methods IV methadone (IV-M) is only provided in France under early access after request from French Medicines Agency (Compassionate Access Authorization). IV-M may be administered using a patient-controlled analgesia (PCA) pump. All cancer patients starting IV methadone between April 2020 and March 2026 were included. Demographics, cancer characteristics, history of prior antalgics, cross titration between previous opioid to methadone, combined use of analgesics and co-analgesics, side effects and patient outcomes were summarized descriptively and collected from the electronic health records.

Results 12 patients were included, 75% female, median age 46 [21-69]. Majority of cancers were metastatic sarcoma (75%). Indications for switching opioid to IV-M were refractory cancer pain (100%) and not possible oral route (58%). Most patients were receiving oral methadone (O-M) prior to the IV switch (n=10 including 3 patients under a co analgesia regimen) in combination with co analgesics (ketamine n=4, gabapentinoids...). 2 were receiving morphine via PCA. The mean daily O-M dose was 80.7mg [30-130mg]. Starting IV-M dosing ranged from 24–112 mg daily dose as a continuous PCA infusion allowing 10% of the total daily dose to be delivered as boluses. For patients previously receiving O-M, the oral to IV conversion ratio ranged from 71% to 90% (mean 79%); ratio values were consistent with current expert society recommendations (80%). Adverse effects were reported in six patients, primarily confusion, hallucinations, and QT prolongation necessitating dose reduction but not treatment cessation.

Conclusion and Relevance In this real-world cohort, switching from oral to IV methadone appears to be an effective option for managing refractory chronic pain in palliative care, when virtually no alternative options existed. Adherence to appropriate conversion ratios, along with clinical (ECG) and biochemical monitoring (electrolytes) ensures satisfactory safety. This management should be carried out by specialized teams

Background and Importance The role of neuropsychiatric clinical pharmacists is underutilized, with few institutions offering comprehensive medication management through psychiatric pharmacists. This study aims to assess the knowledge, attitude, and practice of healthcare workers regarding neuropsychiatric pharmacy services in a pediatric oncology setting. Specially due to the neuropsychiatric complications faced by pediatric oncology patients and their families due to a cancer diagnosis, and their chemotherapy or radiotherapy can negatively impact their quality of life.

Materials and Methods A descriptive cross-sectional study was conducted using a validated questionnaire to assess knowledge, attitudes, and practices toward neuropsychiatric pharmacy services.Data were collected from a total of 141 participants, comprising 82 pharmacists and 59 physicians. Responses were analyzed using descriptive statistics to assess knowledge and attitude levels between the two groups. Comparative analyses were performed using appropriate statistical tests to identify a significant differences between pharmacists and physicians.

Results Pharmacists expressed significantly higher confidence (57.3%) in selecting appropriate neuropsychotropic medications compared to physicians (37.2%) with a p-value of 0.0108. regarding weaning neuropsychotropic medications pharmacists showed greater confidence (61%) compared to physicians (35.5% with a highly significant p-value of < 0.001. Moreover, pharmacists (79.3%) were significantly more confident in managing drug-drug interactions and side effects compared to physicians (30.5%) with a p-value of < 0.001. A significant difference in interest levels was observed, with 81.7% of pharmacists expressing interest in neuropsychiatric pharmacy training compared to 47.4% of physicians (p < 0.001). Furthermore pharmacists had a significantly more positive attitude (p < 0.001) towards counselling and educating patients and nurses about neuropsychiatric medications compared to physicians.

Conclusion and Relevance This study highlights the critical role of neuropsychiatric clinical pharmacists in the multidisciplinary management of pediatric oncology patients These findings underscore the need for expanding the role of neuropsychiatric pharmacists in pediatric oncology settings to improve medication management and optimize patient outcomes.

Background and Importance Dose reduction(DR) and treatment delay(TD) are frequently used in oncology to manage toxicities. However, their impact on clinical efficacy, particularly in the treatment of patients with metastatic triple-negative breast cancer(mTNBC) receiving sacituzumab govitecan(SG), remains uncertain. The toxicity profile of this drug, such as neutropenia and diarrhea, often requires DR and/or TD, raising questions regarding its safety and effectiveness[1,2]. Evidence from the ASCENT trial suggests that DR don't compromise efficacy and may even be associated with longer progression-free survival(PFS)[3].

Materials and Methods We conducted a retrospective observational study from January 2022 to September 2025, including all patients with mTNBC treated with SG. DR, TD and time to progression or death were analyzed. For statistical analysis we use Kaplan-Meier survival curves and compare with Log- Rank test (Mantel-Cox) to assess whether there is a statistically significant difference between the survival curves to evaluate the time to the occurrence of an event, such as death or disease progression. Data was extracted from electronic medical records.

Results We analyzed 54 female patients, with a mean age of 55 years, mean weight of 66 kg, and ECOG 0–1 in 79.6% (n=43). The mean number of administrations (min–max) was 11.6 (1–54) and the average duration of treatment was approximately 4.9 months. DR was required in 25 (46%) patients and 29 (53%) maintained the initial dose. According to the Kaplan-Meier survival curve graph, shows that patients with DR had better PFS over time, with a median PFS of 7.7 months, compared to 3.9 months in the group without DR. Statistical analysis using the Log-Rank test confirmed that this difference is statistically significant (p=0.021). Regarding TD, 37 (69%) patients had at least one TD and 17 (31%) completed the cycles without interruptions. The median PFS was 5.8 months in TD vs 3.9 months in the group without TD. The Log-Rank test did not reach statistical significance (p = 0.311).

Conclusion and Relevance Results show that DR did not compromise clinical efficacy, and it was associated with improvement in PFS, in agreement with ASCENT trial. TD did not demonstrate a significant impact on PFS. The sample small size was a limitation of this study. These findings support dose individualization of SG as a safe and effective strategy for toxicity management, treatment continuation and improving outcomes.

Background and Importance Denosumab is a fully human monoclonal antibody directed against the receptor activator of nuclear factor κB ligand. By inhibiting the interaction between RANKL and its receptor RANK, denosumab reduces osteoclast formation, function, and survival, leading to decreased bone resorption and increased bone mineral density. As a result, a significant component of calcium metabolism is affected. The aim of this study was to determine the incidence of hypocalcemia in patients with metastatic breast cancer receiving denosumab and to identify potential risk factors for the development of hypocalcemia.

Materials and Methods Thirty patients with metastatic breast cancer were included in this study. The mean age was 68 ± 12 years. All patients received denosumab for the prevention of skeletal-related events. Prior to treatment initiation, all patients were supplemented with calcium and vitamin D. Serum albumin-adjusted calcium, albumin, phosphate, creatinine, urea, creatinine clearance, as well as urinary calcium and phosphate levels were measured at baseline and monthly after denosumab administration.

Results Renal function remained normal in all patients throughout the monitoring period, with creatinine clearance consistently greater than 65 mL/min. One patient developed hypocalcemia (80 mg/L), corresponding to Grade 1 hypocalcemia. Four patients presented with low urinary calcium levels (25, 32, 35, and 43 mg/24 h, respectively). Serum calcium levels were normal in three of these patients. The lowest urinary calcium value (25 mg/24 h) was observed in the patient with Grade 1 hypocalcemia. These findings suggest that hypocalciuria may represent a potential risk factor for the subsequent development of hypocalcemia. This study is ongoing and will ultimately include 100 patients with bone metastatic cancer.

Conclusion and Relevance Our results highlight the importance of assessing and correcting vitamin D and calcium levels prior to denosumab initiation. In addition, regular monitoring of renal function, as well as serum and urinary calcium levels, is recommended during treatment to allow early detection and prevention of hypocalcemia

Background and Importance [177Lu]Lu-PSMA-617 significantly improves survival in mCRPC, as demonstrated in the VISION trial. However, in real-world settings, Adverse Drug Reactions (ADRs) are often underreported, particularly delayed events occurring after hospital discharge. Telepharmacy represents a crucial tool to bridge this gap. We present the preliminary results of the "Real-Lu177-mCRPC" study, aimed at implementing an active pharmacovigilance program via pharmacist-led teleconsultation to assess safety, efficacy, and Quality of Life (QoL) in a real-world population.

Materials and Methods This prospective, observational study enrolls PSMA-positive mCRPC patients treated with [177Lu]Lu-PSMA-617. Patients receive specific educational counseling and diaries. A key innovation is the pharmacist-led teleconsultation performed 7 days post-infusion to detect delayed toxicities. ADRs are graded according to CTCAE v5.0 and causality is assessed using the Naranjo algorithm. Data collected via teleconsultation are compared with standard electronic medical records (eMR) and the Summary of Product Characteristics (SPC). Efficacy (OS, PFS) and QoL (EORTC-QLQ-C30/PR25) are evaluated.

Results Preliminary analysis (July 2024-January 2026, N=20 actively monitored patients) reveals 162 Adverse Drug Reactions (ADRs). Notably, pharmacist-led active pharmacovigilance identified 41 ADRs (25.3% of total) not classified in the SPC, demonstrating the value of tele-monitoring. Compared to the pivotal VISION trial, our cohort showed significantly higher reporting rates for low-grade toxicities, specifically Asthenia (75% vs 43.1% in VISION) and Xerostomia (55% vs 39.3%), likely attributable to proactive questioning at day 7 post-infusion. We also detected frequent off-target events such as urinary urgency (40%) and hyperkalemia (20%). Active monitoring enabled the early detection of these events, allowing for timely clinical assessment and appropriate patient counseling. These findings confirm that patient-reported outcomes via telepharmacy significantly reduce underreporting compared to passive surveillance.

Conclusion and Relevance Preliminary findings indicate that integrating pharmacist-led teleconsultation significantly minimizes ADR underreporting in [177Lu]Lu-PSMA-617 therapy. This active pharmacovigilance model enhances patient safety and provides crucial real-world evidence, complementing pivotal trial data and optimizing the clinical management of mCRPC patients.

Background and Importance Oral targeted therapies have substantially transformed the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Although these agents enable long-term outpatient management and improved clinical outcomes, their effectiveness in real-world practice is often limited by suboptimal medication adherence, adverse effects, and clinically relevant drug–drug interactions. Pharmacists play a key role in addressing these challenges within multidisciplinary care models.

Materials and Methods A systematic literature review was conducted in PubMed, Scopus, and Google Scholar for studies published between 2010 and 2025. Eligible studies included randomized trials, cohort studies, and observational reports focusing on adherence, patient knowledge, dose optimization, adverse effect monitoring, and interdisciplinary collaboration. Key quantitative outcomes were extracted and synthesized using descriptive statistics and narrative analysis.

Results Pharmacist-led interventions improved adherence to over 90% (up to 96.8%), higher than standard care (88.6% vs 65.8%, p = 0.0046). Patient understanding increased from 43% to 95%, and early detection of adverse effects and drug–drug interactions was enhanced (19% and 14% of interventions, respectively). Intervention acceptance was high (up to 82%). Clinical outcomes improved, with response rates rising from ~60% to 83.3% and a 59% increase in medication- related error detection. Limitations include variability in study designs and reporting. These results emphasize the practical relevance of pharmacist involvement.

Conclusion and Relevance Integrating pharmacists into oral CLL/SLL care enhances adherence, safety, and clinical outcomes. Structured pharmacist-led programs are feasible, evidence-based, and can be implemented in similar hospital settings to optimize patient management and therapy effectiveness.

Background and Importance Imatinib is tyrosine kinase inhibitor that inhibits the activity of the Bcr-Abl tyrosine kinase. It is primarily metabolized in the liver by cytochrome P450 enzymes, and concomitant use of drugs, foods, fruit juices, or dietary supplements that are substrates, inducers, or inhibitors of these enzymes may significantly alter its therapeutic efficacy and safety profile.The aim of this study was to identify clinically significant drug interactions. The findings aim to highlight potential risks in therapy management and support optimization of pharmaceutical care to improve patient outcomes.

Materials and Methods A retrospective study was conducted at the Hematology Clinic in Skopje, N.Macedonia, in patients diagnosed with CML during the period April–June 2024. Medical records of 34 patients receiving imatinib were reviewed by a clinical pharmacist, with a focus on concomitant medications and drug interactions.Anamnestic data on additional drugs, herbal products, and dietary supplements were collected. Potential interactions were identified using Stockley’s Interactions Checker, categorized according to clinical significance, and subclassified based on pharmacokinetic or pharacodynamic mechanisms.

Results A total of 18 clinically significant interactions were identified. Seven interactions were classified as severe, involving paracetamol (76%), Hypericum perforatum (St. John’s wort) products (26%), atorvastatin (9%), lansoprazole (6%), simvastatin (3%), acenocoumarol (3%), and dutasteride (3%). Eleven interactions were moderate, including grapefruit (26%), tamsulosin (12%), insulin, lercanidipine (6%), alprazolam (6%), metformin (6%), amlodipine (3%), verapamil (3%), domperidone (3%), glibenclamide (3%), and levothyroxine (3%). The most frequently reported adverse effects among patients were pain in the extremities (41%), muscle cramps (35%), nausea and vomiting (29%), and periorbital edema (26%).

Conclusion and Relevance Clinical pharmacists play a pivotal role in identifying and managing drug interactions in patients undergoing imatinib therapy. Close monitoring is essential to prevent adverse reactions and therapeutic failure resulting. The integration of structured pharmaceutical care in the management of patients with chronic myeloid leukemia can enhance treatment safety and optimize therapeutic outcomes.

Background and Importance Immunoconjugates combine a monoclonal antibody with a cytotoxic payload and are increasingly used across tumor types but they are associated with relevant toxicities. Oral mucositis/stomatitis is a frequent adverse event with some immunoconjugates, and prophylaxis with barrier agents and dexamethasone 0.1% mouthwash is recommended in supportive care guidance. We assessed oral mucositis outcomes in patients receiving immunoconjugates who initiated prophylaxis with dexamethasone 0.1% mouthwash plus oral barrier agents from the first infusion.

Materials and Methods We performed a retrospective observational analysis of adult patients (≥18 years) with solid tumors receiving immunoconjugate therapy after first-line treatment during 2025, with ECOG <2. All patients received prophylaxis from the first infusion consisting of dexamethasone 0.1% mouthwash (20 mL, four times daily) plus oral barrier agents administered three times daily, spaced apart. Oral mucositis was graded according to CTCAE v5.0. The primary endpoint was prevention of oral mucositis; a secondary endpoint was limitation of severity to low-grade events to minimize impact on quality of life and treatment delivery. For grade 2 mucositis, treatment was delayed until improvement to grade 1 or complete resolution and an additional compounded mouthwash containing hydrocortisone 0.04%, lidocaine 0.08% and nystatin 0.26% was introduced. The same escalation approach was applied for grade 3 mucositis.

Results Among 89 adults receiving immunoconjugate every 2 weeks under prophylaxis, 47 patients (52.8%) did not develop oral mucositis, while 32 (36.0%) experienced a maximum of grade 1, 9 (10.1%) grade 2, and 1 (1.1%) grade 3 (Table 1). Grade 2–3 events required treatment delay until improvement to grade 1 or complete resolution and escalation to a compounded mouthwash with topical anesthetic and anti-inflammatory/antifungal components. Overall, prophylaxis did not fully prevent low-grade mucositis but was associated with mostly low-severity events and rare high-grade toxicity. No cases of oral candidiasis were observed, including in the grade 3 event.

Conclusion and Relevance In this observational analysis, prophylaxis with dexamethasone 0.1% mouthwash plus oral barrier agents was associated with predominantly low-grade oral mucositis during immunoconjugate therapy, with very rare grade 3 events.

Background and Importance Antimicrobial resistance poses a critical threat to public health and oncological efficacy. Antibiotics disrupt gut microbiota, impairing immunotherapy outcomes. Our retrospective study (n=246) confirmed that high antibiotic exposure impairs immunotherapy efficacy, as confirmed by other studies (Nat Rev Clin Oncol. 2023 Oct; Simpson RC et all). Consequently, the educational project aims to minimize unnecessary prescriptions and promote patient awareness use of antibiotics to prevent dysbiosis, thereby improving clinical efficacy and fighting Antimicrobial Resistance (AMR).

Materials and Methods This project addresses the impact of antibiotics on immunotherapy. A retrospective analysis of 246 patients analyzed survival outcomes based on antibiotic use. Findings prompted an ongoing 12-month educational intervention for staff and patients using video interviews, illustrated comics, and counseling at the pharmacy direct distribution counter. Post-intervention efficacy will be evaluated by comparing antibiotic consumption (DDD, WHO Watch/Access shifts), re- prescription rates, and patient awareness score, aiming to optimize Antimicrobial Stewardship.

Results Retrospective analysis identified antibiotic exposure (AE) as a critical determinant for survival outcome in patients treated with immunotherapy. Patients with high AE (>10.67%) had a median OS of 6.4 vs 23.5 months for low AE (<10,67%) (p=0.00003). Addressing this, the project focuses on education and "Responsible Prescription". The intervention promotes precision diagnosis, WHO AWaRe adherence, avoiding unnecessary prescriptions and antibiotic use for viral infections. The aim is to minimize microbiome disruption and resistance through conscious prescribing and patient awareness.

Conclusion and Relevance Evidence confirms that high antibiotic exposure compromises survival of immunotreated patients. This project aims to enhance patient awareness of antibiotics proper use through an educational intervention and promote the use of the most appropriate molecules for infections. This initiative safeguards the microbiome, establishing Antimicrobial Stewardship as essential to preserve treatment efficacy

Background and Importance Cancer is the second leading cause of death in Serbia. Most cancer patients develop multiple comorbidities, resulting in polypharmacy and increased risk of potential drug-drug interactions (pDDI). The situation is even more critical in the elderly, in whom there is almost systematic polypharmacy with an average of nine prescribed and over-the-counter medications per patient. The aim of this study was to analyse potential DDIs in cancer patients.

Materials and Methods A cross-sectional study included all adult outpatients with cancer, who had ≥2 medications, treated in a Military Medical Academy (MMA), a tertiary, university hospital in Belgrade, Serbia. Data were obtained from the Pharmacy medical charts, where prescribed drugs were collected over a six-month period. The Lexicomp Interact (Lexi-Comp, Inc, Hudson, Ohio) database was used to identify pDDIs. Data were analysed using descriptive analysis and multiple logistic regression. The MMA Ethics Committee approved the research.

Results In total, 77 patients were included in the study, with an average age of 78.36±12.02 (51-93 years). Male patients accounted for 54.54 %. Patients were prescribed 2 to 17 medications (6.61±3.55). Approximately one-quarter of patients (18) had 5 medications prescribed, while 14 patients had 8. Potential DDIs were observed in 74.03% of patients, while category X interactions (avoid combination) were detected in 3.87%. Pharmacodynamic mechanisms accounted for most interactions, as similarly reported in the literature. The most important was potentially significant DDI between enzalutamide, a drug for the treatment of prostate cancer, and apixaban, a direct oral anticoagulant, leading to decreased apixaban concentration. Apixaban should not be coadministered with enzalutamide. An increase in the number of prescribed medications was significantly associated with a higher number of pDDIs.

Conclusion and Relevance Careful choice of drugs can reduce pDDIs and their potential adverse drug reactions in cancer patients. Close monitoring of these pDDIs should be carried out at the start and during anticancer therapy, to prevent reduced drug efficacy or treatment-related adverse effects.

Background and Importance Palbociclib (PAL) and ribociclib (RIB) are commonly used to treat hormone positive HER2 negative metastatic breast cancer. PAL is started at 125 mg daily dose, RIB at 600 mg, and both follow a 3 weeks on + 1 week off protocol (21+7 days). However, many patients do not tolerate full dose due to adverse events. Therefore, an analysis was made in order to describe and compare the rate of patients treated with a reduced dose in our hospital.

Materials and Methods Metastatic breast cancer patients treated with PAL and RIB as first line treatment were searched. Women in treatment during 1 to 3 years were included in the study, and follow up ended in Januay 2026. The following data was collected: age, treatment time, dose reduction, protocol change and toxicity. Toxicity was assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 5, published in 2017. Dose reductions were made following manufacturer’s indications. Finally, a comparison of both drug groups was carried out.

Results 20 patients were in treatment with PAL and 25 with RIB. Mean age was 75 (53-98) in PAL group and 63 (40-79) in RIB group. Patients received treatment for an average of 22 (RIB) and 27 (PAL) months. 64% needed RIB dose reduction (400 mg/day), and 24% 200 mg/day. In 35% of patients, PAL started in reduced doses because of advanced age or comorbidities; 45% reduced dose to 100 mg/day, and 75 mg/day was final dose in 65%. Most changes were caused by grade 3 and 4 neutropenia (50% and 5% PAL; 52% and 8% RIB). 1 patient in each group had trombopenia and 1 alteration of hepatic enzymes (grade 1 PAL; grade 2 RIB). Finally, 1 patient reduced RIB due to dermic toxicity, and 1 PAL due to subjective bad tolerance. First dose reduction was carried out in a median of 2.5 (RIB) and 3 (PAL) cycles, and second in 8.5 and 6. Grade 3 neutropenia caused protocol change to 3 weeks on + 2 off regimen in 8% RIB and 25% PAL patients. 2 women interrupted RIB for toxicity, 1 vitiligo and 1 general discomfort.

Conclusion and Relevance Full dose treated patients were 36% PAL and 45% RIB population. Final minimum PAL dose (75 mg/day) administered in 65% of patients, and RIB (200 mg/day) in 24%. PAL population was older, so it may explain variation. Most reductions were due to neutropenia (55% PAL, 60% RIB). In resume, most patients cannot tolerate full dose because of hematological toxicity, reducing dose in early cycles.

Background and Importance Conventionally patient information leaflets (PILs) have been the mainstay of information resource provided by healthcare professionals (HCPs) for patients (P) and their caregivers (C) on P’s treatment. At our ambulatory cancer centre (ACC), pharmacists provide P&C with printed PILs (pPILs) for oral anti-cancer medications (OAM). However, in this modern era, it is uncertain if pPILs are still of value or P&C would prefer to refer to other sources for information. Hence, this study aims to determine the usefulness of pPILs among P&C.

Materials and Methods Single-centre, cross-sectional study. P ( > 21 year-old) on >1 OAM were recruited. P/C were surveyed on PIL usage patterns & on PIL format (prefPIL). Demographic characteristics of respondents (R) were compared between P & C using Chi-square/Fisher's Exact test for categorical variables (v) and Mann-Whitney U/2-sample T test for continuous v. Logistic regression (LR) was used to access the factors & frequency of PIL usage. Multinomial LR model was developed to assess the relationship between demographic variables & prefPIL. 2-sided p- value < 0.05 was considered statistically significant.

Results Total of 308 R ((75.6% P, 24.4% C) participated. Mean age of R was 57.8 + 12.8 years old and P were older than C (60.3 vs 49.5 year-old; p< 0.001). Almost half (45.1%) had breast cancer and 68.8% had at least a Pre-University education. Majority of R did refer to pPIL (83.1%) but only once in 48.7%. Main reason for referring to pPILs was for side effects of medications (M) and how to manage them (56.8%). R cited top 3 most useful sections of pPILs as (1) common side effects (70.3%), (2) precautions when on M (24.3%) and (3) when to seek medical attention (26.2%). After adjusting for the demographic characteristics, there were no factors associated significantly with the frequency & usage of pPIL. For those who did not refer to pPIL (15.6%), the top alternative source of information was the internet (55.3%).Most R (65.3%) were satisfied with the PIL format. C, females, R aged 60 and above had higher odds of preferring pPIL (p <0.05).

Conclusion and Relevance This study demonstrated that majority of P&C still relied on pPILs for information on OAM though frequency of reference was low. It also provided valuable insight that side effects and their management is of paramount importance to them. Future studies can look into how to customize PILs, to provide useful information required and improve their accessibility.

Background and Importance Antimicrobial stewardship (AMS) in paediatric oncology units (POUs) optimises antibiotic use to reduce the development of antibiotic resistance. Yet, very little has been published about AMS in African POUs. This study assessed implementation and identified facilities offering paediatric cancer and AMS services.

Materials and Methods A web-based, cross-sectional survey was conducted from September to October 2025 and examined AMS practice in POUs across Africa. Quantitative and qualitative analyses were done using a Microsoft Excel Workbook.

Results The survey received 94 responses from 32 (59%) African countries; of which 80 (85%) were included in the final sample after removing duplicate institution responses. Sixty-five (81%) health facilities provided POUs. Among these, 42 (65%) have AMS programs. Support was provided by health facility leadership for the AMS programs in 37/42 (88%) facilities. This included hospital leaders involved in implementing appropriate antimicrobial use initiatives as part of their broader health programs. Additionally, 30/42 (71%) facilities integrated AMS activities into their reporting to national AMS committees, and 29/42 (69%) facilities designated AMS champions. The evaluation of healthcare professionals' accountability within the AMS program in paediatric cancer services demonstrated that 36/42 (86%) of the facilities have a designated AMS committee. Whereby, 24/42 (57%) health facilities provided antimicrobial susceptibility testing services, and 19/42 (45%) had antibiograms.

Conclusion and Relevance In Africa, POUs have limited access to AMS programs for effective antibiotic management. Professionals rely on standardized international guidelines due to a lack of institutional antibiograms and training programs, underscoring the need for more educational resources. Many health facilities also lack familiarity with integrating AMS into POUs.

Background and Importance Hematological therapies involve potent medications with significant risks for drug related problems (DRPs) due to their high complexity and toxicity. Pharmaceutical consultation might enhance medication safety and efficacy. The aim of this evaluation is to determine a timepoint where hematological patients benefit the most from pharmaceutical involvement. For this, we evaluated the number of DRPs at three different time points of care: Before, during and at maintenance chemotherapy. Another goal was to increase the efficacy of pharmaceutical counseling, as not all patients can be covered.

Materials and Methods DRPs were classified according to the Pharmaceutical Care Network Europe “Classification for DRPs”. Pharmaceutical consultations were carried out by two pharmacists specialized in hemato-oncological pharmacy. The pharmacists took part in interdisciplinary round tables before the initiation of chemotherapy, actively participated in hospital rounds for patients undergoing chemotherapy and carried out medication consultations at the start of maintenance therapies. Next to the patients age, the number of interventions, the reason for intervention and the degree of acceptance were documented.

Results A total of 60 patients (20 per timepoint) were screened between 2022-2026. Overall, 25 interventions were found: 16 at maintenance therapy, 6 during and 5 before the start of chemotherapy. The high number of DRPs in maintenance therapy could be explained by polypharmacy, drug-drug interactions and increased vulnerability due to pre-treatments. Another critical factor is the transition of care to ambulatory care. The most common cause of intervention was interactions (=10), lack of therapy (=5) and adverse drug reactions (=4). The most prominent interactions were due to polypharmacy combined with CYP3A4 inhibitors. Adverse drug reactions included diarrhea, hypomagnesemia and skin toxicity. The category “lack of therapy” includes missing prophylaxis for infection and supportive therapy. The cause of DRPs encourages the involvement of pharmacists in hemato-oncological treatment, as they can support interdisciplinary teams in the management of interactions and reduce complications.

Conclusion and Relevance The highest number and most critical interventions were found during maintenance therapy suggesting that it could be more efficient to concentrate pharmaceutical care to this specific timepoint. Other forms of pharmaceutical support may be more effective before or during chemotherapy, which should be evaluated.

Background and Importance In oncology, swallowing disorders may require placement of devices feeding tubes. The administration of chronic treatment by this devices may alter the pharmacokinetic parameters of these treatments and lead to iatrogenic events. A systematic identification of patients admitted for device placement was implemented, involving the pharmacy team and the physician, with the aim of anticipating and identifying the need for for dosage-form adaptations in pre-admitted patients. The objective was to assess the contribution of the clinical pharmacy team on patients with swallowing disorders.

Materials and Methods Over a 6-month period, for every patient with an indication of placement of a gastric decompression device, the prescribing physician informed the pharmacy team by email. The pharmacy resident or the clinical pharmacist performed a comprehensive medication review, assessed potential drug interactions, and proposed dosage-form adaptations when needed. Patients were identified prior to their admission for device placement, which allowed the physician to adjust the patient’s treatment without delay at the time of the procedure.

Results 24 patients were included with a median age of 72 years. The median number of prescribed drugs per patient was 9, with a median of 3 medications requiring a pharmaceutical intervention. A drug-related problem requiring a pharmaceutical intervention was identified in 21 patients, for a total of 73 interventions. In most cases, the indication was gastrostomy placement (54%) or nasogastric tube placement (20%). The most frequent therapeutic classes according to the ATC classification were alimentary tract and metabolism (40%), the nervous system (21.4%), and the cardiovascular system (14.3%). The main type of pharmaceutical intervention concerned optimization of the modalities of administration (97%). All medication reviews associated with the interventions were available to the prescriber in the electronic medical device before the patient’s admission for device placement, 42% of which were made available before admission. Overall, 72 interventions (98.6%) were accepted by the prescriber

Conclusion and Relevance This study highlights the high frequency of drug-related issues in oncology patients with swallowing disorders, particularly those related to dosage-form adaptations. Collaboration between prescribers and clinical pharmacists is essential to anticipate, identify, and adjust all types of treatments, thereby limiting the risk of inefficacy and reducing iatrogenic risk.

Background and Importance Home hospitalisation (HH) has been shown to be as safe as traditional hospitalisation, while offering advantages for patients and healthcare systems. These include a decreased risk of exposure to nosocomial infectious agents, an improved perception of the quality of the overall process, and reduced costs and hospital stays. The objective of this study is to describe the implementation of a HH programme for haematology patients at a tertiary hospital, from the perspective of the Pharmacy Department (PD), with a particular focus on the role of the oncology-haematology pharmacist (OP).

Materials and Methods A multidisciplinary working group, comprising haematologists, pharmacists and nurses was established to design the HH programme. The group defined patient inclusion and exclusion criteria and developed standard operating procedures related to the medication circuit including: - Definition of schedules for medication validation, preparation and dispensing. - Selection of medications to be included in the HH nursing kit. Demographic and clinical characteristics of the first patients enrolled in the HH programme were collected and analysed descriptively to evaluate its initial implementation.

Results The main characteristics of the medication circuit are as follows: - The OP performs daily follow-up of patients admitted to a virtual ward and validates any changes to treatment. - Medication is dispensed in single doses three times per week, as well as whenever a new treatment is initiated. The HH nursing kit was adapted to include the main medications used, such as antiemetics, oral prophylactic anti-infective agents, corticosteroids, and growth factors. The HH programme was launched in May 2024. To date, 20 patients have been included (70% male, average age 54). The main indications for inclusion in the program were: 14 patients (70%) following autologous haematopoietic stem cell transplantation, 4 patients (20%) early discharge and 2 patients (10%) for chemotherapy administration (subcutaneous azacitidine, arsenic trioxide). The average length of stay in the HH programme without readmission was 15 days. Thirteen patients (65%) required readmission, mainly due to fever (77%).

Conclusion and Relevance This study highlights the high frequency of drug-related issues in oncology patients with swallowing disorders, particularly those related to dosage-form adaptations. Collaboration between prescribers and clinical pharmacists is essential to anticipate, identify, and adjust all types of treatments, thereby limiting the risk of inefficacy and reducing iatrogenic risk.

Background and Importance Mosunetuzumab is a CD20/CD3 bispecific monoclonal antibody that redirects T cells against CD20-positive B cells, inducing immune synapse formation and targeted cytotoxicity. It is approved as an orphan medicinal product for adults with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. We report the first clinical experience with mosunetuzumab at our hospital, focusing on its effectiveness and safety in a heavily pretreated patient.

Materials and Methods Descriptive case report of a 70-year-old woman diagnosed in 2015 with stage IV diffuse large B- cell lymphoma (DLBCL), treated with 8 cycles of R-CHOP, followed by R-DHAP and radiotherapy for sacral relapse. In June 2025, PET-CT showed multiple infradiaphragmatic hypermetabolic masses. Excisional biopsy confirmed grade 3A follicular lymphoma (FL). Due to relapse, CAR-T ineligibility, and prior intensive chemo-radiotherapy exposure, third-line with mosunetuzumab was initiated. Efficacy was evaluated by clinical assessment and PET-CT. Safety was assessed through adverse event monitoring.

Results At baseline, the patient had an ECOG 0–1, with pain related to nodal disease. During cycle 1, she experienced mild infusion-related symptoms (nausea, vomiting, transient tachycardia and low-grade fever). Grade 1 cytokine release syndrome (CRS) was suspected after the third dose (day +15), characterised by fever without haemodynamic instability or neurotoxicity. No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Transient cytopenias and transaminase elevation resolved without intervention. A febrile urinary tract infection caused by Klebsiella pneumoniae responded to antibiotics without treatment delay. From cycle 2 onwards, treatment was well tolerated, with only mild self-limiting symptoms. The patient reported progressive pain improvement and reduced analgesic use. Interim PET-CT after five cycles demonstrated complete metabolic response. Treatment was completed after eight cycles as planned, maintaining complete remission and good tolerability.

Conclusion and Relevance Mosunetuzumab is an effective and manageable therapeutic option in heavily pretreated FL. Treatment achieved complete metabolic remission with predominantly grade 1 adverse events and no neurotoxicity. Our experience supports the incorporation of bispecific antibodies into routine clinical practice and highlights their potential as chemotherapy-free strategies in relapsed or refractory FL.

Background and Importance Anal squamous cell carcinoma (ASCC) is a rare malignancy with limited options in advanced disease. First-line treatment is carboplatin–paclitaxel. Retifanlimab, a PD-1 inhibitor approved by the FDA, has shown benefit when added to first-line chemotherapy. It has recently been approved in Europe but is accessible only through clinical trials or expanded access programs. We report our first use of retifanlimab under expanded access, assessing clinical outcomes and safety in combination with chemotherapy, and emphasizing the role of the oncology pharmacist in enabling access to novel therapies.

Materials and Methods A 71-year-old man was diagnosed in April 2025 with metastatic ASCC (T2N1M1) involving liver and lymph nodes and presenting severe anal pain (Visual Analog Scale 10). The patient received the standard three week regimen of carboplatin and paclitaxel, and retifanlimab was incorporated from cycle 3 through an expanded access program, adjusting to a four-week schedule according to the Summary of Product Characteristics.Clinical course, laboratory parameters, radiological response (PET-CT), and adverse events and immune-related toxicities were systematically monitored by the oncology–pharmacy team.

Results The patient showed marked clinical improvement, including pain resolution and improved performance status. Laboratory parameters remained stable with liver enzymes progressively normalized after six cycles (ALT 83→22 U/L; AST 40→17 U/L; alkaline phosphatase 123→100 U/L). Treatment was delayed twice due to thrombocytopenia (nadir 89,000/μL) with rapid recovery. After six chemotherapy cycles (four combined with retifanlimab), PET-CT demonstrated complete visceral response and significant reduction of the primary anal lesion, consistent with an overall partial response. The patient subsequently received radical radiotherapy to the primary tumor with concomitant weekly carboplatin–paclitaxel. Adverse events included grade 2 asthenia and grade 1 mucositis managed on an outpatient basis. Grade 3–4 immune-related colitis attributed to retifanlimab required hospitalization and systemic corticosteroids.

Conclusion and Relevance This case illustrates the clinical and radiological benefit of retifanlimab in metastatic ASCC. Treatment demonstrated a manageable safety profile despite the immune-related toxicity. The expanded access program enabled timely incorporation of an innovative therapy, highlighting the essential role of hospital pharmacy in facilitating access to emerging oncologic treatments.

Background and Importance Apalutamide, enzalutamide, and darolutamide are androgen receptor antagonists that are used to treat prostate cancer. Apalutamide and enzalutamide are strong cytochrome inducers – they have impact on CYP 3A4, CYP2C9, and CYP2C19, thus interacting with many commonly used drugs. Furthermore, apalutamide is a P-gp and OATP inducer. On the other hand, darolutamide affects far fewer drugs, because it only inhibits transport proteins BRCP and OATP.

Materials and Methods Apalutamide, enzalutamide, and darolutamide were selected as a model group of drugs for evaluation by clinical pharmacists in our hospital. For each patient receiving these drugs, physicians request pharmacist evaluation of potential drug interactions. The pharmacist uses the patient’s national electronic prescription record to identify current medication. UpToDate interaction checker was used as primary source of information, further information was sought in SmPCs, online interaction databases, and individual case reports, studies, etc.

Results From November 2025 to February 2026, 155 patients were evaluated; 6 patients could not be evaluated because their record was inaccessible. In 11 patients we found combinations that should be avoided (X), in 17 patients combinations where therapy modifications should be considered (D), in 93 patients combinations where therapy should be monitored (C). Only in 34 patients no action was needed (A or B) or no known interaction was present. The most threatening interactions we encountered were with direct oral anticoagulants, ivabradine, and opioid analgesics. In several cases we also found notable interactions or contraindications not related to our model drugs. All findings were reported in the patients’ documentation. In case they were clinically significant, the physician was contacted immediately with proposed solution.

Conclusion and Relevance Czechia uses national electronic prescription record accessible to medical doctors, pharmacists, and patients. Unfortunately, some modern cancer therapies do not follow the standard prescribing process and are therefore excluded. Our results show the importance of interaction checking and the need to amend healthcare regulations to include these drugs in electronic evidence of prescription.

Background and Importance The increasing use of oral anticancer therapies partly shifts treatment responsibility to patients and may raise the risk of medication errors and compromised medication safety. Complex administration schedules may be difficult for patients to fully understand during routine medical consultations, particularly in elderly populations. Capecitabine requires a 14-day treatment period followed by a 7-day rest period, while trifluridine/tipiracil is administered on days 1–5 and 8–12 of a 28-day cycle. The aim of this study was to evaluate patient understanding and pharmacist intervention impact.

Materials and Methods A prospective observational study was conducted during 2025 in a hospital outpatient pharmacy service, providing follow-up for about 463 patients per month with different pathologies. Patients receiving oral anticancer therapies with complex administration schedules, specifically capecitabine or trifluridine/tipiracil, were included. Patient understanding was assessed during dispensing through direct questioning. A pharmacist intervention using structured visual dosing calendars was performed and the teach-back method was applied. Patients were consecutively included during routine care.

Results During 2025, 100 patients receiving capecitabine were evaluated. Twenty patients (20%) initially demonstrated incorrect understanding of the treatment schedule, mainly related to confusion regarding treatment and rest periods. Seven patients received trifluridine/tipiracil, with two patients (28.6%) showed misunderstanding of the administration schedule. After pharmacist intervention using the visual dosing calendar, all patients correctly explained their treatment schedule using the teach-back method and no subsequent phone calls were received by oncology or pharmacy services regarding medication administration. The main limitation is the small number of patients treated with trifluridine/tipiracil and the single-centre design.

These findings highlight clinically relevant misunderstandings in routine practice, particularly in elderly patients receiving complex oral regimens with safety implications. Most errors were related to confusion regarding treatment and rest periods.

Conclusion and Relevance A relevant proportion of patients receiving oral anticancer therapies initially misunderstand complex dosing schedules. Pharmacist intervention using visual dosing calendars improved treatment comprehension and prevented further medication-related queries. This strategy represents a simple and effective tool to improve medication safety in routine clinical practice, especially in elderly patients.

Background and Importance Invasive fungal infection (IFI) is a major cause of morbidity and mortality in acute leukemia because of prolonged neutropenia and intensive chemotherapy. However, data on antifungal consumption, fungal epidemiology, and prescribing quality in low- and middle-income hematology settings remain limited. This study evaluated antifungal use trends and prescribing appropriateness at a national tertiary hematology center in Vietnam.

Materials and Methods A mixed-method drug utilization evaluation was conducted at the National Institute of Hematology and Blood Transfusion. Hospital-wide antifungal consumption from 2020 to 2024 was measured using WHO defined daily dose (DDD)/100 patient-days. A retrospective review included acute leukemia patients receiving systemic antifungals for suspected or confirmed IFI in the chemotherapy ward between November 2024 and February 2025. Appropriateness was assessed using a structured stewardship framework based on international guidelines.

Results Total antifungal consumption ranged from 16.0 to 28.4 DDD/100 patient-days, with triazoles accounting for 91–97% of overall use. Among 175 acute leukemia patients, median age was 46 years and 73.7% had acute myeloid leukemia. Median treatment duration was 10 days. Candida spp. and Aspergillus spp. were the main pathogens, with a predominance of non-albicans Candida. Overall, 83.4% of prescriptions were appropriate. Inappropriate use was mainly related to suboptimal agent selection, incorrect dosing, and excessive duration. Adverse drug events occurred in 18.3% of patients, and clinically significant drug–drug interactions in 22.9%, mostly involving azoles. These findings support the need for targeted antifungal stewardship, particularly in the context of azole resistance and safety concerns.

Conclusion and Relevance Antifungal prescribing in acute leukemia patients was generally appropriate and consistent with international standards. However, persistent issues in drug selection, dosing, duration, and azole-related safety highlight the need for focused antifungal stewardship interventions to optimize treatment and improve patient safety

Background and Importance Oncolytic viruses represent a novel therapeutic approach in oncology. RP1, a genetically modified HSV-1 administered intralesionally, is increasingly used in combination with immune checkpoint inhibitors, introducing additional clinical and logistical complexity. Its incorporation into hospital practice requires multidisciplinary coordination, workflow adaptation, and safe integration into existing care pathways.

Materials and Methods Descriptive analysis of the implementation of RP1 in combination with systemic immunotherapy in a tertiary hospital. Variables assessed included storage requirements, ultra-low temperature management at a biomedical research facility, transport conditions, preparation workflow, administration process, traceability, and coordination between pharmacy, oncologic dermatology, oncology teams, and the research institute.

Results RP1 required ultra-low temperature storage (-80°C), external freezer support, and strict cold chain monitoring. Transport logistics were coordinated with external providers. Intralesional administration was performed by an experienced dermatology team. Medication management and protocol compliance were ensured by pharmacy, including protocol development, safety documentation, and medication preparation with direct handover for immediate administration.

Implementation was achieved without protocol deviations or safety incidents. The combination with immunotherapy increased coordination complexity and requiered close alignment between teams. This experience reflects a shift from conventional drug management to advanced biological therapies requiring coordinated patient-centered care.

Conclusion and Relevance The integration of oncolytic viral therapy combined with immunotherapy is feasible in clinical practice, but requires significant logistical adaptation and highly coordinated multidisciplinary teamwork. This approach highlights the role of hospital pharmacists in managing advanced biological therapies and ensuring safe, traceable, and effective implementation.

Background and Importance Oncology patients are increasingly complex, with multiple comorbidities and innovative therapies — including oral targeted agents — generating significant risk of drug-drug interactions and poor adherence. Communication gaps between hospital specialists and general practitioners further compromise care continuity. Despite Ministerial Recommendation No. 17, structured hospital pharmacist-led medication reconciliation in oncology remains underimplemented in Italy. Objective: To evaluate the feasibility of a pharmacist-led medication reconciliation service in oncology using pre-defined KPIs.

Materials and Methods Prospective feasibility study started in March 2025 at the Medical Oncology Units of S. Jacopo (Pistoia) and SS. Cosma e Damiano (Pescia) Hospitals Italy. Patients were selected based on oncologist queries addressing polypharmacy, complex therapies or risk of drug-drug interactions and toxicities. The pharmacist conducted consultations reviewing all medications and supplements. Two structured reports were generated per patient: a reconciliation and drug interaction report for the oncologist and a patient-oriented medication guidance report. Pre- defined KPIs were used to measure service impact.

Results As of submission, 43 patients (mainly breast cancer) had been evaluated, demonstrating feasibility of the service within approximately 3 hours of pharmacist time per week. Preliminary KPI data showed: 57 therapy modifications (including introductions, discontinuations and dose adjustments) across 43 patients, suggesting that nearly every patient benefited from at least one pharmacist-driven intervention; 11 specialist consultations requested; 10 follow-up visits conducted in selected cases; 8 adverse drug reaction (ADR) reports filed in the national pharmacovigilance network. The study highlighted the importance of hospital-territory integration: sharing the pharmacological evaluation report with the general practitioner (GP) — who manages the patient's overall therapy — emerged as a critical need. GP-level KPIs and integration with the Electronic Health Record (FSE 2.0) represent the primary planned next steps. Limitation: absence of GP-level outcome data in the current phase.

Conclusion and Relevance A pharmacist-led medication reconciliation service generates measurable clinical value for patients, oncologists and GPs, improving therapy appropriateness and care continuity. The KPI framework ensures this is an evaluable intervention. This model is replicable beyond oncology to any specialist setting. Future steps include GP integration, FSE 2.0 linkage and AI tools implementation.

Background and Importance Myelofibrosis (MF) is a rare chronic myeloproliferative neoplasm characterized by bone marrow fibrosis and extramedullary hematopoiesis. JAK inhibitors improve symptoms but cause hematologic toxicity and CYP3A4-mediated drug interactions. As MF mainly affects elderly, polymedicated patients, structured multidisciplinary management may improve safety and treatment optimization.

Materials and Methods We performed a 4-year retrospective observational study using electronic medical records. Patients with MF who attended at least one multidisciplinary consultation (advanced practice nurse, hematologist, pharmacist) were included. Demographic data, treatments, follow-up, and therapeutic modifications were analyzed descriptively.

Results Twenty-eight patients were included (mean age 74.4 years [58–90]; 80% are polymedicated). They attended a mean of five consultations over a median follow-up of 13 months. Baseline treatments were fedratinib (n=5), momelotinib (n=7), ruxolitinib (n=11), ruxolitinib plus azacitidine (n=1) or ruxolitinib plus peg-interferon (n=4). All patients required treatment adjustment for intolerance and/or insufficient efficacy, including dose reduction, discontinuation, or hydroxyurea addition to control myeloproliferation. Among ruxolitinib- treated patients, 25% required dose reduction or discontinuation, mainly due to hematologic toxicity. Overall, systematic analysis of drug–drug interactions between MF and concomitant therapies covered 130 drugs. Antihypertensives were the most evaluated class (30%) followed by antiplatelet agents (18%), mainly aspirin. These results underline the need for continuous therapeutic reassessment, particularly with newer agents in elderly polymedicated patients.

Conclusion and Relevance MF management requires ongoing treatment reassessment. Through multidisciplinary collaboration, pharmacists optimize treatment by monitoring toxicities, managing drug–drug interactions, ensuring adherence, and coordinating care, thereby improving safety and outcomes in this complex patient population.

Background and Importance Chronic myeloid leukemia (CML) was one of the first malignancies who benefit from tyrosine kinase inhibitors (TKIs), that profoundly transforming its prognosis. This therapeutic shift enabled a transition from hospital-based to predominantly outpatient care. However, this evolution exposes patients to specific medication-related risks, including non-adherence, drug– drug interactions, and adverse events. Multidisciplinary consultations involving physicians, clinical pharmacists, and advanced practice nurses were implemented. This study evaluates the impact of pharmacist interventions (PIs).

Materials and Methods We conducted a 4-year retrospective observational study using electronic health records. Pharmacist interventions were assessed according to the French Society of Clinical Pharmacy (SFPC) classification. Adult CML patients attending at least one multidisciplinary consultation were included. Data collected included TKI prescriptions, frequency and type of PIs, underlying drug-related problems (DRPs), and a subgroup analysis comparing initiation and follow-up consultations in matched patients.

Results A total of 226 consultations were analyzed for 34 patients. Six TKIs were prescribed: nilotinib (31%), asciminib (24%), dasatinib (17%), bosutinib (11%), ponatinib (9%), and imatinib (8%). Overall, 56% of consultations required ≥1 PI (n=133). Main DRPs were adverse drug reactions (54.9%), need for monitoring optimization (15.8%), omission of supportive care (9.0%), drug– drug interactions (8.3%) and contraindications (0.8%). Interventions mainly included addition of medication (47.4%), monitoring optimization (17.3%), treatment discontinuation (15.0%), improved administration modalities (14.6%), dose adjustment (7.8%) and deprescribing (6.8%). Adverse events were mainly gastrointestinal, dermatological, and metabolic (notably hyperuricemia), primarily managed by supportive treatments (69.9%). In matched patients (16 initiation, 18 follow-up), 133 PIs were identified (76 vs 57), with a higher PI/consultation ratio during follow-up (1.02 vs 0.80), reflecting ongoing optimization needs.

Conclusion and Relevance CML illustrates the shift toward outpatient oncology driven by TKIs. Multidisciplinary consultations are essential to secure these oral therapies. Multidisciplinary team play a key role in identifying DRPs, managing adverse events and optimizing treatment. Strengthening the city- hospital network, for both pharmacists and nurses, improves continuity of care.

Background and Importance The evolution of oncologic therapies has improved survival and increasingly transformed cancer into a chronic condition. The growing use of oral anticancer treatments allows patients to manage therapy at home, improving quality of life but increasing responsibility for correct administration and toxicity monitoring. Cancer patients often experience multimorbidity and polypharmacy, raising the risk of drug interactions and adverse reactions. To enhance treatment safety, appropriateness, and adherence, a structured four-phase multidisciplinary medication review process was implemented.

Materials and Methods This prospective monocentric study involves adult cancer or hematologic patients treated at the Veneto Institute of Oncology with polypharmacy (≥5 chronic medications). Patients were either starting oncologic therapy or undergoing pre-hospitalization for surgery. A multidisciplinary team performed structured medication review and deprescribing interventions, assessing therapy appropriateness using the Medication Appropriateness Index (MAI). Follow-ups at 3, 6, and 12 months evaluated the sustainability of the intervention and drug-related problems.

Results Preliminary evidence from an ongoing study involving 27 oncologic and hematologic patients demonstrated the feasibility and relevance of a multidisciplinary medication review and deprescribing intervention. Using the MAI as the primary outcome measure, a 17% reduction in MAI score was observed one month after the intervention, indicating improved prescribing appropriateness. Medication review enabled the identification of potentially inappropriate medications (PIMs), drug–drug interactions, therapeutic duplications, and other drug-related problems (DRPs), supporting targeted deprescribing actions and optimization of supportive therapies. The multidisciplinary approach also promoted patient education and increased awareness of treatment adherence and toxicity management. Integration of telemonitoring and telepharmacy tools may further support remote follow-up of patients receiving oral therapies at home, enabling earlier detection of adverse events and reinforcing adherence.

Conclusion and Relevance Multidisciplinary medication review and deprescribing are key strategies to improve pharmacological appropriateness in polytreated oncologic patients. The next step is implementing a structured model across regional oncology centers, integrating pharmacovigilance, patient counseling, and teleconsultation to strengthen care coordination and improve the quality and safety of pharmaceutical care.

Background and Importance In oncology, pharmacists play a key role in the treatment safety and the optimization of care for hospitalized patients. The objective of our study is to evaluate the nature, acceptance, and the impact of pharmaceutical interventions (PIs) conducted at the Salah Azaiz Institute.

Materials and Methods A prospective descriptive study was conducted over two months (July and August 2025) at the Salah Azaiz Institute, covering six departments: Surgical Oncology, Intensive Care, Radiotherapy, Adult and Pediatric Medicine, and Otorhinolaryngology (ENT). Computerized physician orders (CPOs) for inpatients were analyzed by pharmacists using the STKMED software. Each intervention was tracked and recorded according to the SFPC (French Society of Clinical Pharmacy) intervention form. Data were collected and analyzed using Excel. The CLEO scale was used to assess clinical, economic, and organizational.

Results A total of 1,266 prescriptions were analyzed, resulting in 32 pharmaceutical interventions (PIs), primarily in Intensive Care (47%), Surgery (31%), Radiotherapy (12.5%), and ENT (9.5%). The most frequent issues identified were: dosage adjustment (34%), contraindication/non- compliance with guidelines (19%), unjustified prescription (19%), non-compliant prescription (13%), monitoring required (9%), and medication not received by the patient (6%). PIs were accepted by prescribers in 68% of cases. Refusals to dispense accounted for 32% (including 16% after contacting the prescriber and 16% without contact). The clinical impact was rated as major (3C) in 34%, moderate (2C) in 21%, minor (1C) in 28%, and nil in 15% of cases. The economic impact was favorable with cost reduction (+1E) in 75% of cases, an increase (-1E) in 16%, and no impact in 9%.. The organizational impact was favorable in 78% of cases and null in 22%.

Conclusion and Relevance The pharmaceutical interventions performed led to a significant improvement in the relevance and safety of oncology prescriptions, showing high acceptability and positive clinical, economic, and organizational impacts.

Background and Importance Zolbetuximab use in routine practice is associated with a relevant toxicity burden, particularly during early treatment cycles, with nausea and vomiting being especially prominent, alongside other frequent adverse events such as abdominal pain, cramping, and fatigue. These toxicities may compromise tolerability and treatment continuity, underscoring the need for proactive supportive care strategies. Describe the implementation of an institutional administration protocol, designed by a transdisciplinary team, to optimize safety, tolerability, and early toxicity management in the first patient.

Materials and Methods Available evidence, including the GLOW and SPOTLIGHT trials and the SmPC, was reviewed. Based on this evidence, physicians, pharmacists, and nurses developed an institutional administration protocol incorporating intensified antiemetic prophylaxis, a stepwise infusion schedule, and a structured algorithm for prevention and management of common treatment- related toxicities, including nausea, vomiting, abdominal pain/cramping, fatigue, and infusion- associated symptoms. The protocol was implemented in the first patient treated at our center, with structured monitoring during and after infusion.

Results Premedication included netupitant 300mg plus palonosetron 0.5mg PO, dexamethasone 10mg IV, and rescue medication with metoclopramide 10mg IV and ondansetron 8mg IV. Clemastine 2mg IV and famotidine 40mg PO were added to reduce infusion-related reactions. Post- medication consisted of olanzapine 5mg PO once daily on D1–5 and dexamethasone 8mg twice daily on D2–3. The patient had a history of inflammatory bowel disease, potentially increasing emetic risk and complicating gastrointestinal symptom assessment. During the first infusion, a sudden vomiting episode occurred at the first rate-escalation step, requiring temporary interruption and resumption at a reduced rate, with no recurrence. On Day 7, severe nausea after olanzapine discontinuation led to its reintroduction with good effect. Structured follow-up also supported early recognition and management of abdominal discomfort and fatigue. During the second infusion, a single nausea episode was successfully managed according to protocol.

Conclusion and Relevance Advance preparation and close collaboration among medical, pharmacy, and nursing teams enabled timely intervention, standardized decision-making, and safer care delivery. Patient- reported outcomes after the first administration informed refinement of supportive measures. Structured, individualized supportive care was essential to optimize tolerability and sustain zolbetuximab treatment continuity.

Background and Importance Cisplatin is associated with dose-dependent nephrotoxicity and electrolyte disturbances, particularly hypomagnesemia. Hydration protocols are essential for toxicity prevention, yet no standardized regimen has been established, and practices vary across institutions. Real-world data on the impact of protocol changes, especially on electrolyte balance, remain limited. This study aimed to evaluate the impact of a hydration protocol modification on renal function and electrolyte levels in adult patients with solid tumors.

Materials and Methods A single-center retrospective observational study was conducted in adult patients with solid tumors receiving cisplatin. Two periods were analyzed: pre-change (P1: May–August 2025) and post-change (P2: September–December 2025) of the hydration protocol. Patients were stratified by cisplatin total dose (≤80 mg vs >80 mg). The revised protocol reduced hydration volume and adjusted electrolyte supplementation (Mg, K, ±mannitol) and timing. Data collected included demographics (age, sex, tumor type), number of cycles, serum creatinine, creatinine clearance, and electrolyte levels (Mg, K, Ca).

Results A total of 142 patients were analyzed (P1: n=62; P2: n=80), with similar baseline characteristics. The incidence of hypomagnesemia increased from 22% in P1 to 46% in P2. In the post-change group, 28/49 patients receiving ≤80 mg cisplatin developed hypomagnesemia (57%), compared to 9/27 patients receiving >80 mg cisplatin (33%). Despite higher cycle numbers in the >80 mg subgroup in P2 (6.07 vs 4.57), hypomagnesemia remained more frequent in the lower dose subgroup. Serum potassium and calcium levels showed minimal differences between periods, and renal function remained stable. These findings suggest that the timing of magnesium supplementation (before vs after cisplatin), rather than total dose or cumulative exposure, may play a key role in preventing hypomagnesemia. The modified hydration protocol maintained renal safety but did not fully prevent magnesium loss in patients receiving lower cisplatin doses, highlighting the importance of early or pre-infusion magnesium administration.

Conclusion and Relevance The modified hydration protocol was associated with a higher incidence of hypomagnesemia, particularly in patients receiving <80 mg cisplatin. This may be related to differences in magnesium supplementation timing rather than dose or cumulative exposure. Renal function remained stable, supporting the overall safety of the protocol, but highlighting the need for optimized magnesium administration.

Background and Importance Oncology patients receive complex systemic therapies associated with polypharmacy, an increased risk of drug-drug interactions and significant treatment-related toxicities, which may negatively impact adherence and overall treatment outcomes. In real-world practice, adverse drug reactions (ADRs) are often underrecognized or insufficiently managed, highlighting a gap in medication monitoring. Pharmacist-led structured counseling may support safer medication use and improve patient engagement. This study aimed to assess its impact on adherence, ADR detection, and pharmacotherapy optimization.

Materials and Methods We conducted a single-center retrospective observational study including adult oncology patients initiating oral anticancer therapy between August 2024 and August 2025. Patients received structured pharmaceutical counseling (15-30 minutes) at treatment initiation, with targeted follow-up during the first three treatment cycles. Counseling included medication review, identification of drug interactions, detection of drug-related problems (DRPs), and patient education, including adverse reaction management. Adherence was evaluated based on patient self-report during follow-up interviews.

Results A total of 668 patients initiated oral anticancer therapy during the study period, with approximately 55 patients monthly. Among them, 271 patients (40.6%) reported at least one adverse drug reaction. Gastrointestinal toxicities were the most frequent, followed by neurological and general disorders, with nausea, diarrhea, constipation, and fatigue being the most common. High treatment adherence was observed, with 97% of patients reporting compliance. Patients were relatively evenly distributed by sex, with ADRs reported across both groups. Structured pharmaceutical counseling enabled early identification of clinically relevant drug-drug interactions and DRPs and supported timely management of treatment-related toxicities. These findings highlight the role of the pharmacist in improving medication safety in oncology practice. Access to counseling was limited for some patients due to out-of-pocket costs, potentially reducing the number of patients included in follow-up.

Conclusion and Relevance Structured pharmaceutical counseling represents a key component of multidisciplinary oncology care. Pharmacist-led interventions may improve adherence, enhance early detection and management of adverse drug reactions, and optimize treatment safety through continuous patient monitoring. Expanding access to such services could further improve patient outcomes in oncology practice.

Background and Importance Oncological therapy causes a wide range of adverse effects that patients often do not report to their oncologist, underestimating their clinical importance. Symptoms such as dry eye, skin changes, depression, constipation, and dysgeusia (metallic taste) directly compromise quality of life, nutritional status, and treatment outcomes. By systematically monitoring the frequency of these adverse effects and recognizing them early, community pharmacists play a direct role in their timely identification and in providing supportive care outside the hospital setting.

Materials and Methods A systematic literature review was conducted using PubMed and EMBASE databases, including studies published up to 2025. The search focused on oncology patients collecting oral anticancer therapy or supportive medicines in community pharmacies. The following keywords were used: “oncology pharmacy”, “cancer-related side effects”, “xerophthalmia”, “dysgeusia”, and “chemotherapy-induced constipation”. Studies highlighting the pharmacist’s contribution to the management of treatment-related toxicity and adverse effects in the outpatient setting were analysed.

Results A review of 55 studies confirms that adverse effects are highly prevalent in oncology. Dysgeusia affects up to 70% of patients on chemotherapy and may cause weight loss, while xerophthalmia occurs in 20–30% of patients treated with targeted therapies, particularly EGFR inhibitors. Dermatological toxicities rank among the most frequent reasons for pharmacist consultation but are often managed inadequately. Constipation induced by opioids or antiemetics is frequently under-treated. Depression is under-recognized in oncology patients, as is misinterpreted as cancer-related fatigue. Evidence suggests that community pharmacists, through regular patient contact during dispensing, can identify such symptoms up to 14 days earlier than scheduled oncologist appointments. A major limitation is the lack of integrated protocols between community and hospital pharmacists. Quantitative data indicate that pharmacist-led interventions by approximately 25% can reduce the severity of adverse effects.

Conclusion and Relevance Effective management of adverse effects in oncology patients within community pharmacies is crucial for successful therapy. Conditions like dry eye, skin toxicity, depression, constipation and dysgeusia require an active, pharmacist-led approach. The findings highlight the need to strengthen oncology skills in community pharmacies and to develop national guidelines for supportive care in Croatia.

Background and Importance Immunotherapy (ICI) success depends on gut microbiome composition, which modulates anti- tumor responses and immune-related adverse events (irAEs). Certain bacteria increase the risk of severe toxicities (e.g., colitis), impairing quality of life, clinical outcomes, and causing rehospitalizations. Pre-therapy microbiome profiling and recommending targeted, standardized probiotics move irAE management toward precision therapy. In community pharmacies, uncritical probiotic use contributes to poor outcomes; thus, defining pharmacist-led oncology counseling guidelines is essential.

Materials and Methods Databases including PubMed and Scopus were searched for the period 2018–2026. Key studies (Gopalakrishnan et al., 2018; Spencer et al., 2021) linking microbiota diversity with the occurrence of irAEs and comparing targeted versus commercial probiotics were analysed. The focus was placed on clinical outcomes such as survival and toxicity in relation to pharmacist- led interventions in patients at risk of dysbiosis due to polypharmacy (e.g. antibiotics, proton pump inhibitors). The potential role of microbiome profiling in guiding personalised therapeutic strategies was also evaluated.

Results Studies confirm that patients dominated by Ruminococcaceae exhibit better responses, while dysbiosis correlates with severe immune-mediated colitis. A key finding (Spencer et al., Science 2021) indicates that generic probiotic use reduces microbial diversity compared to high fiber intake. However, pre-therapy microbiome profiling enables targeted interventions, shifting from generic to precision probiotics. This personalized approach minimizes toxicity and prevents therapy interruptions. Community pharmacists must oversee polypharmacy and discourage self-initiated OTC products that interfere with the immune response. By emphasizing fiber-rich diets and recognizing early irAE symptoms based on microbiome status, the pharmacist directly implements precision pharmacy and medicine. Personalized microbiome modulation ensures treatment stability and better quality of life, bridging the gap between standard care and precision pharmaceutical care.

Conclusion and Relevance Microbiome profiling is a cornerstone of immunotherapy safety. The community pharmacist plays a vital role in the oncology team through polypharmacy oversight and precision probiotic counseling. Targeted microbiome modulation reduces toxicity, prevents rehospitalizations, and improves clinical outcomes, ensuring that patients safely continue immunotherapy through personalized care.

Background and Importance Upper urinary tract infections (pyelonephritis) are among the most frequent nosocomial infections. While they typically progress without complications, the involvement of multi-drug resistant (MDR) bacteria complicates clinical management. Consequently, ensuring adequate antibiotic therapy is crucial. This study aims to evaluate the prevalence of upper urinary tract infections among cancer patients and to assess the compliance of their medical management with established clinical guidelines.

Materials and Methods This retrospective study was conducted between August 2023 and August 2024. All patients receiving curative antibiotic therapy during this period were monitored and included. Data collection was performed using dedicated antibiotic monitoring sheets. Antibiotic prescriptions were evaluated for dosage, duration, and selection based on national guidelines (Société Tunisienne de Pathologie Infectieuse) and international standards (Société de Pathologie Infectieuse de Langue Française). Data analysis was performed using SPSS software, version 22.0.

Results One hundred and twenty patients were included in the study. The prevalence of pyelonephritis was estimated at 14.16% (N=17). Severity markers were observed in several cases: 41.17% (N=7) presented with simple pyelonephritis, 35.29% (N=6) with signs of severity, and 23.52% (N=4) with complicated pyelonephritis. The most frequently isolated pathogen was Escherichia coli (41.17%), with ESBL-producing Escherichia coli present in 28.57% of cases. Cefotaxime was the most commonly prescribed antibiotic. The majority of prescriptions (64.7%) were found to be inappropriate according to guidelines, and antibiotic combinations were inadequate in 54.54% of cases.

Conclusion and Relevance Our study demonstrates a significant rate of inappropriate antibiotic prescribing. These alarming results should encourage clinicians to re-evaluate their prescribing practices and align them with clinical guidelines to prevent the emergence of bacterial resistance.

Background and Importance Introduction/Background Chemotherapy is a high-risk treatment modality due to complex protocols, individualized dosing, narrow therapeutic margins, and the need for continuous assessment of clinical and laboratory parameters. Breakdowns in the verification process may lead to preventable medication errors that can directly affect patient safety. A standardized chemotherapy verification process led by clinical pharmacists may provide an effective safety barrier to detect and resolve treatment-related problems before drug preparation and administration.

Materials and Methods A service evaluation was conducted within the Egypt Healthcare Authority from January to May 2025. A standardized chemotherapy verification process was implemented by the clinical pharmacy team in routine oncology practice. Verification included protocol compliance, dose appropriateness, required laboratory parameters, order completeness, and supportive care review before chemotherapy preparation and administration. A total of 800 chemotherapy orders were reviewed, and all pharmacist interventions were documented and categorized.

Results Among 800 reviewed chemotherapy orders, 150 clinical pharmacy interventions were recorded, representing an intervention rate of 18.75%. The standardized verification process enabled identification and prevention of medication-related problems before they reached the patient. Most interventions were identified before preparation and administration. Protocol deviations were among the most commonly detected issues, alongside dose errors requiring adjustment, missing laboratory parameters, incomplete orders, and supportive care optimization needs. These findings demonstrate the value of pharmacist-led verification as a proactive safety strategy in oncology. The process improved consistency in chemotherapy order review, supported earlier resolution of treatment-related issues, and strengthened multidisciplinary communication. A limitation was the absence of direct patient outcome measures and pre- implementation comparison.

Conclusion and Relevance Clinical pharmacy-led standardized chemotherapy verification was effective in identifying and preventing clinically relevant medication-related problems before reaching the patient. With nearly one intervention for every five reviewed orders, this model showed meaningful safety impact and supports the leadership role of clinical pharmacists in oncology care. It is practical and transferable.

Background and Importance Health literacy in oncology patients receiving oral anticancer drugs (OAD) is a crucial factor for therapeutic success.The ESOP Global WG Oral Cancer Drugs has developed a template for patient information leaflets (PIL) about OAD to improve the quality of patient counseling. Its’ unique selling points are a brief format (two pages) as well as the focus on relevance and comprehensibility.Apart from the template, the WG also creates pre-filled, drug specific PIL (ds- PIL).The WG’s goal is to facilitate health care providers’ access to standardized materials for patient education around the world.

Materials and Methods The PIL template was first designed in 2023 in English, available as open-source document via the ESOP Global website. To ensure a uniform standard focusing on relevant information and patient-friendly language, the WG developed a guideline for PIL authors. The main source for ds- PIL is the respective drug’s SmPC. The WG’s goal is to publish ds-PIL for all approved OAD. In a first step, 30 OAD were selected and prioritized for creating ds-PIL. When establishing the guideline and writing the ds-PIL, already existing patient education material from multiple countries was taken into account.

Results By March 2026 (abstract deadline), the template has been translated into 14 languages, published via the ESOP Global homepage. The WG has authored 15 ds-PIL, written in English. Creating further ds-PIL and translating the documents is an ongoing process. Technology- supported workflows are to be designed to minimize the workload. Future tasks of the WG will also include the establishment of routine processes to ensure high quality standards (e.g., proof reading, standardized wording, regular updates). To promote global access and PIL usage, multi- national strategies need to be developed to increase health care providers’ level of awareness about these documents and their benefits.

Conclusion and Relevance The PIL about OAD are an important tool for improving health literacy in oncology patients. Preparation of high-quality material is labor-intensive and time consuming, which poses challenges, especially for volunteers like the WG. Wide acceptance and usage are essential to achieve the desired effect of supporting health care professionals to provide the best care possible to oncology patients.

Background and Importance The convergence of nanotechnology and radiopharmaceutical science represents a transformative approach in precision oncology. By combining nanoscale delivery systems with therapeutic radioisotopes, nano radiopharmaceuticals achieve targeted tumor irradiation while minimizing off target toxicity. Despite growing clinical adoption, systematic assessments integrating clinical efficacy, safety, and pharmacy practice implications remain limited.

Materials and Methods A systematic search was conducted in PubMed, EMBASE, Cochrane Library, Web of Science, and ClinicalTrials.gov from January 2015 to August 2025, following PRISMA guidelines. Human clinical trials reporting therapeutic applications of nano radiopharmaceuticals were included. Two reviewers independently screened and extracted data on study characteristics, efficacy outcomes, safety profiles, manufacturing requirements, and pharmacy practice implications.

Results Of 3,247 records screened, 89 studies involving 12,456 patients were included. Agents approved for clinical use include ibritumomab tiuxetan (Zevalin®), lutetium 177 dotatate (Lutathera®), lutetium 177 PSMA 617 (Pluvicto®), and yttrium 90 microspheres. Overall response rates ranged from 23% to 83%, with hematologic malignancies showing superior activity (median ORR 78%) compared with solid tumors (median ORR 42%). Grade 3–4 toxicities occurred in 15–45% of patients, mainly hematologic. Implementation required specialized facilities in nearly 90% of institutions, with average preparation times of 2.5–4.8 hours and costs per treatment course ranging from $15,000 to $85,000.

Conclusion and Relevance Nano radiopharmaceuticals have demonstrated substantial clinical efficacy with manageable toxicity profiles across multiple cancer types. Their integration into oncology

Background and Importance Undesirable effects of chemotherapy, including neutropenia, neuropathy, and nausea, frequently compromise treatment efficacy and patients' quality of life. Artificial intelligence (AI) offers innovative approaches for proactive and personalized management of these toxicities through advanced predictive models and real-time clinical monitoring systems.

Materials and Methods A systematic review of published studies between 2020 and 2024 was conducted using PubMed and Scopus databases. The review included 12 clinical trials testing predictive models based on machine learning and deep learning algorithms, five studies on AI platforms in clinical practice (ChemOA, OncoBot), and analyses of patient-reported outcomes (PROs) and biometric data.

Results Three major areas of advancement were identified. First, in early prediction, LSTM (Long Short- Term Memory) models demonstrated the ability to predict neutropenia 72 hours in advance with an area under the curve (AUC) of 0.89. A significant reduction in hospitalizations was observed, comparable to results reported by Chen et al. in 2022. Second, regarding real-time monitoring, chatbots like OncoBot successfully reduced toxicity reporting delays by 40% while detecting neuropathy with 88% precision. Third, in therapeutic adjustments, posological adaptation algorithms decreased treatment interruptions by 30%. Challenges: Several significant limitations were identified, including bias from underrepresentation of aged populations in training datasets, limited interoperability with existing hospital information systems, and variable acceptability among clinicians who may be hesitant to adopt AI-driven recommendations.

Conclusion and Relevance AI represents a revolutionary approach to toxicity management in oncology, demonstrating substantial potential for improving patient outcomes and quality of life. However, its successful implementation requires clear regulatory frameworks and interdisciplinary collaboration among oncologists, pharmacists, data scientists, and healthcare administrators.

Background and Importance Artificial intelligence (AI) is revolutionizing healthcare education, particularly in oncology pharmacy, where the complexity of treatments and rapid evolution of protocols necessitate advanced pedagogical tools. The integration of AI-driven educational platforms offers unprecedented opportunities to enhance learning experiences, improve clinical decision- making skills, and prepare future oncology pharmacists for the challenges of modern cancer care. However, the implementation of these technologies faces significant barriers including bias in training algorithms and accessibility issues.

Materials and Methods A comprehensive review of recent publications (2020-2024) was conducted using PubMed and Google Scholar databases, supplemented by conference proceedings in pharmaceutical education. Search terms included AI, pharmacy education, oncology training, and virtual patients. Studies were selected based on their relevance to AI applications in oncology pharmacy education and their methodological rigor.

Results Four major areas of AI impact on oncology pharmacy education were identified. In clinical simulation, platforms like OncoSim improve mastery of complex regimens (immunotherapy, targeted therapies) through safe virtual scenarios. Adaptive learning algorithms identify individual knowledge gaps and personalize content, particularly for managing adverse drug reactions and patient counseling. Specialized chatbots such as OncoBot provide 24/7 instant responses on drug interactions and ASCO/ESMO guidelines. Predictive analytics using machine learning detect early difficulties in dosage calculations and patient counseling, enabling targeted support. Limitations: Algorithmic bias from non-representative datasets risks perpetuating healthcare disparities. Unequal access to technical infrastructure deepens educational inequalities. Ethical concerns remain around data privacy, student surveillance, and the balance between AI assistance and independent clinical reasoning.

Conclusion and Relevance AI offers significant opportunities to personalize oncology pharmacy education, better preparing students for complex clinical practice. Successful implementation requires collaboration between educators and data scientists to ensure ethical use and alignment with professional competencies. Future research should establish regulatory frameworks and best practices for AI integration.

Background and Importance Immunotherapy, particularly with immune checkpoint inhibitors (ICIs), has revolutionized the prognosis of many cancers. However, it can induce complex, unpredictable, and potentially severe immune-related adverse events (irAEs). Their early recognition and appropriate management are essential to prevent serious complications and preserve the therapeutic benefit.

Materials and Methods We report two clinical cases of patients treated, in Batna Cancer Hospital (CLCC de Batna), for stage IV melanoma and metastatic clear cell renal carcinoma who developed irAEs under immunotherapy. Management was analyzed according to toxicity grades (CTCAE) and current guidelines (NCCN Guidelines V 2.2025).

Results 1st:a 64-year-old woman treated with Pembrolizumab for melanoma, developed grade I-II cutaneous toxicity, managed with antihistamines and topical corticosteroids without trt interruption. Following initial pseudoprogression, the occurrence of generalized erythroderma with pustules (grade III-IV) led to permanent discontinuation of immunotherapy, along with oral and topical corticosteroids, and a specialized dermatology consultation. Outcome was marked by metastatic progression after a two-month trt interruption. 2nd:a 65-year-old woman treated with Pembrolizumab and Axitinib for renal cell carcinoma, developed grade I diarrhea (managed with antidiarrheals without treatment interruption), followed by asymptomatic grade II cytolytic hepatitis (temporary interruption, laboratory monitoring). Recurrent cytolysis (grade II-III) required corticosteroid therapy. After six cycles, severe keratitis with corneal perforation (grade IV) led to permanent trt discontinuation and ocular enucleation.

Conclusion and Relevance These cases show that irAEs vary in severity. Management should follow a graded approach (interruption, corticosteroids...). Permanent immunotherapy discontinuation may compromise tumor control. Close monitoring and multidisciplinary care are key to balancing efficacy and safety. irAE management requires prompt, graded action and coordination to preserve treatment benefits while limiting harm.

Background and Importance information: The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe, an intergovernmental organisation (based in Strasbourg, France) set up to promote democracy and protect human rights and the rule of law in Europe. The EDQM is responsible for ensuring the fundamental human right of access to good quality medicines and healthcare in Europe.

Aim and Objectives Under the coordination of the EDQM and the oversight of the intergovernmental Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC), a working group was established in 2024 with the aim to develop comprehensive, evidence-based guidelines to support healthcare professionals in advising and educating patients undergoing cancer treatment. Emphasis is placed on oral anticancer therapies and the need for consistent, high-quality counselling across both inpatient and outpatient care settings.

Materials and Methods The guidelines are being developed through a structured, multi-step approach involving an international working group of experts composed of representatives from national medicines agencies, hospital and community pharmacy practice, and European professional organisations (including oncology pharmacy and hospital pharmacy associations). The experts come from different Council of Europe member States, ensuring a broad representation of healthcare systems and professional perspectives. The drafting methodology includes analysis of existing practices across Europe, results from stakeholder surveys (patients, pharmacists, professional societies, and patient organisations), literature searches and iterative drafting with peer review. Individual chapters are prepared by designated authors and reviewed by back-up authors and all the members of the working group. Additionally, a targeted survey on certification and specialisation frameworks in oncology pharmacy is being conducted to support the development of targeted recommendations.

Results The results of the stakeholder surveys carried out in 2025 indicated significant variability in patient counselling practices and training frameworks across Europe, highlighting the need for harmonised guidance. The guidelines under development aim to fill this gap and address key areas such as medication management, lifestyle counselling, communication strategies, and interprofessional collaboration. They also explore structural aspects including regulatory frameworks and the use of supportive educational materials. The development process ensures integration of multidisciplinary perspectives and alignment with real-world practice needs.

Conclusion and Relevance The ongoing EDQM project seeks to develop practical and harmonised guidelines for patient counselling in oncology, ultimately improving the quality and safety of care. By strengthening healthcare professionals’ competencies and supporting patient empowerment, the guidelines are expected to contribute to better therapeutic outcomes and enhanced patient engagement across Europe.

Background and Importance Despite the known incompatibility of morphine and metamizole in PCA pumps, their combined use remains common. The resulting reaction product, metamorphine, has been assumed to possess analgesic potency comparable to morphine. However, new molecular modeling studies suggest reduced activity, and recent in vitro radioligand assays demonstrate an approximately eightfold lower μ-opioid receptor affinity. As recruitment for our interventional COMA study was insufficient, an alternative approach was required to further investigate its pharmacological effects.

Materials and Methods Metamorphine was synthesized from morphine hydrochloride and metamizole. Purification was performed using a Reprosil-Pur Basic-C18 column (5 μm, 150 × 10 mm). For the self-experiment, an aqueous solution containing 20 mg metamorphine was administered orally. Blood samples were collected at baseline and 10, 20, 30, 45, 60, and 120 min post-administration. Serum metamorphine concentrations will be determined by LC–MS using a validated method capable of detecting trace levels of morphine and methylaminoantipyrine.

Results A single oral dose of 20 mg metamorphine produced no detectable effect. This raises the question of why PCA solutions containing metamorphine still provide analgesia. Given its weak μ-opioid receptor activity and lack of observed side effects, higher doses may be feasible, suggesting that metamorphine could act primarily as a peripheral analgesic with minimal opioid-mediated effects. The absence of effect may also be due to limited absorption, which will be clarified by comparing serum levels with effective concentrations observed in patients from our COMA (Combined Opioid and Metamizole Analgesia) study (~0.75 μg/mL).

Conclusion and Relevance A final conclusion is not yet possible. Nevertheless, these findings highlight the need for a more critical evaluation of the pharmacological consequences of drug incompatibilities.

Background and Importance The majority of therapeutic antibodies need to be diluted into infusion bags before administration. As a result, the concentration of stabilizing excipients, such as surfactants, is reduced dramatically. Consequently, antibody susceptibility to mechanical stress is increased. Pneumatic transportation systems (PTS) offer an efficient way of drug transportation in hospitals but are known to cause mechanical stress, leading to aggregation of drug proteins. We investigated if PTS shipping affects the stability and antigen-binding capacity of 5 frequently used antibody drugs in 7 hospitals.

Materials and Methods Bevacizumab (Mvasi®, Amgen), nivolumab (Opdivo®, BMS), pembrolizumab (Keytruda®, MSD), pertuzumab (Perjeta®, Roche) and infliximab (Remsima®, Celltrion) were diluted in infusion bags with NaCl 0.9% and shipped by PTS from pharmacies to oncology wards. Samples were analyzed using visual inspection, fluid imaging microscopy, dynamic light scattering, nanoparticle tracking analysis, size-exclusion chromatography and biolayer interferometry with his-tagged antigens. A handheld mechanical sensor (Voltcraft DL®, Conrad) was used to measure the amount of mechanical stress during PTS shippings.

Results Fluid imaging microscopy (FIM) and nanoparticle tracking analysis (NTA) showed that the number of particles was comparable before and after PTS transportation. These results were confirmed by dynamic light scattering (DLS), showing that antibodies are highly monodisperse and with the expected size. Size-exclusion chromatography (SEC), visual inspection and biolayer interferometry (BLI) confirmed that antibody stability is not affected by PTS shippings. Mechanical stress was observed by varying levels of stress generated by different shipments, equivalent to approximately 3-10 min of orbital shaking at 300 rpm in all 7 hospitals. Orbital shaking of antibody showed that this amount of mechanical stress is below the threshold causing antibody aggregation.

Conclusion and Relevance PTS was confirmed to be a safe way of transportation. However, case-by-case investigations for each drug and hospital remain essential to ensure drug quality. Our experiments showed that PTS transportation did not cause antibody aggregation for 5 examined antibodies in 7 hospitals. In addition, BLI results revealed that the antigen-binding capacity was not affected in the specific circumstances.

Background and Importance Trastuzumab deruxtecan (T-DXd), a third-generation antibody-drug conjugate used in HER2- positive cancers, has limited in-use stability, restricting advance preparation and reuse of infusion bags. A key challenge in ADC stability assessment is the need to consider both antibody integrity and linker-payload stability, including drug-to-antibody ratio (DAR) heterogeneity. This study aimed to assess the extended physicochemical stability of T-DXd diluted in polypropylene infusion bags at clinically relevant concentrations under refrigerated and room temperature conditions.

Materials and Methods Three different T-DXd batches were reconstituted and diluted in dextrose 5% to 1 mg/mL and 4 mg/mL, then stored protected from light at 4°C for up to 28 days. Forced degradation (pH, oxidation, heat, UV/light, mechanical stress, freeze–thaw) demonstrated the stability-indicating capacity of the methods. Analyses included Protein A affinity chromatography (assay), SEC, HIC, CEX, FcγRIIIa affinity (FcR), DLS, SDS-PAGE, and qualitative glycan/sialic acid fluorescence analyses. Detection was performed at 280 nm and ~380 nm. Peptide mapping is ongoing.

Results Forced degradation produced distinct alterations, confirming that the analytical methods were stability-indicating. The most marked changes were observed under heat and UV/light stress, with clear profile modifications versus unstressed samples. Protein A assay remained within ±5% of initial values (D0 = 100%) across all storage conditions, with no consistent decline over time. SEC, HIC, CEX, FcR, and DLS profiles at D28 were comparable to D0, with no significant qualitative changes. DLS remained monomodal, with a Z-average of approximately 10 nm. Co- elution at 280 nm and ~380 nm was preserved throughout storage, supporting maintenance of antibody-payload association. SDS-PAGE showed no additional bands or detectable fragmentation at D28. Qualitative glycan and sialic acid profiles were also preserved. Given the limited sample size and ongoing peptide mapping, physicochemical stability is conservatively supported up to D14.

Conclusion and Relevance T-DXd diluted in 5% dextrose in polypropylene infusion bags at concentrations of 1 mg/mL and 4 mg/mL remains physicochemically stable for at least 14 days when stored at 4°C and protected from light. These results support extended beyond-use dating, facilitating anticipatory compounding and product reassignment, with the potential to reduce drug wastage and improve pharmacy workflow efficiency.

Background and Importance Use of medicines in special situations occurs when they are prescribed for conditions other than those authorised. Such use must be supported by scientific evidence, a favourable benefit– risk balance and comply with the relevant regulations, including clinical justification and informed patient consent. In our hospital, these requests are assessed by a multidisciplinary advisory committee following a structured evaluation by the Pharmacy Department. The aim of the study was to analyse the reasons for approval/rejection, the level of evidence supporting the decisions and their economic impact

Materials and Methods Retrospective study was conducted including all oncology drugs evaluated by the advisory committee from 2023 to 2025. Only PD-L1 inhibitors (nivolumab, pembrolizumab, durvalumab, cemiplimab, atezolizumab and dostarlimab) were included. Collected variables were: age, pathology, administrative status of drugs (off-label use, non-reimbursed, under or without reimbursement evaluation), and cost. Rejected requests were classified as: availability of a valid therapeutic alternative or uncertainty regarding efficacy. For approved ones, level of scientific evidence supporting the decision was analyzed

Results A total of 49 requests (41.2% of all medical oncology requests) were analysed. Main indications were genitourinary (46.9%), digestive (24.5%) and lung tumours (16.3%). A minority of cases involved endometrial, breast, skin, and bone malignancies. Median patient age was 67 years (range 35–87). Pembrolizumab, nivolumab and durvalumab accounted for 89.8% of requests. Regarding administrative status, 36.7% were under reimbursement evaluation, 30.6% were non- reimbursed and 28.6% were off-label uses. Overall, 18.4% of requests were rejected, mainly due to the existence of a valid therapeutic alternative (55.5%). Among approved requests, decisions were predominantly supported by phase III clinical trials (85%). The estimated budget impact of approved requests was €2,092,985, with: 27.5% between €10,000 and €30,000 per year, 37.5% €31,000 and €60,000 per year and 35% above €60,000 per year, while rejected requests would have represented €195,817

Conclusion and Relevance Approval decisions were mainly supported by high-quality clinical evidence, whereas rejections were driven by appropriate therapeutic alternatives. Less than one third of requests lacked European Medicines Agency (EMA) marketing authorisation. Ultimately, this evaluation process enabled early patient access while ensuring responsible use of healthcare resources

Background and Importance Oral anticancer therapies are increasingly used due to their convenience and clinical effectiveness. However, these drugs are often dispensed in full packages, which may lead to drug waste when treatments are dose-adjusted or discontinued. Given the high costs of targeted therapies, such waste represents a significant economic burden. This study aimed to quantify the extent and cost of drug waste associated with oral anticancer therapies in an outpatient oncology setting.

Materials and Methods A retrospective cohort study was conducted at the oncology day care unit, Västmanlands Hospital, Västerås, Sweden. Patients initiating treatment in 2024 with one of the 20 oral anticancer drugs with the highest average reimbursement cost per dispensed package were included. Data on drug use, costs, and treatment modifications were obtained from the Swedish eHealth Agency and electronic health records (Cosmic). Drug waste was defined as unused medication resulting from dose reductions or treatment discontinuation. Descriptive statistics were used to analyse waste costs and proportions.

Results Eighteen drugs and 68 patients were included. The total cost of dispensed oral anticancer drugs was SEK 11.3 million, of which SEK 1.5 million (13.2%) was attributed to drug waste. The highest absolute waste costs were observed for osimertinib (SEK 244,750), dabrafenib (SEK 214,018), and cabozantinib (SEK 198,486). These findings demonstrate that drug waste represents a substantial proportion of treatment costs. Dispensing medications in full packages reduces flexibility when treatment is modified or discontinued. Strategies such as adjusted dispensing practices and redispensing programmes may reduce waste and improve resource efficiency.

Conclusion and Relevance Drug waste from oral anticancer therapies accounted for 13.2% of total treatment costs, representing a significant economic inefficiency. Optimising dispensing practices may reduce waste and improve the sustainability of oncology care.

Background and Importance Approximately 42,000 patient-specific chemotherapy and biological medicines are prepared annually in the hospital pharmacy of North Estonia Medical Centre Foundation. To evaluate the quality of oncology pharmacy services and the organization of preparation unit operations, a satisfaction survey was conducted among healthcare professionals. The questionnaire included four sections: communication, BD Cato chemotherapy prescribing software, medication preparation and in-hospital logistics, and drug-related information.

Materials and Methods A web-based satisfaction survey was conducted using REDCap over a two-week period at North Estonia Medical Centre Foundation. Physicians and nurses from oncology, hematology, and related units participated. Satisfaction was assessed using a five-point scale (extremely satisfied, very satisfied, satisfied, rather dissatisfied, not satisfied at all), with an optional free- text field for additional comments.

Results A total of 53 healthcare professionals responded (34% physicians, 66% nurses). Communication with pharmacy staff received high satisfaction scores regarding professionalism, responsiveness, and handling urgent situations. Lower satisfaction was reported for the BD Cato chemotherapy prescribing software, mainly due to insufficient training. Most users learned about the system informally from colleagues, although pharmacist support was rated very highly. Physicians emphasized the need for updated and more clinically relevant treatment protocols. Preparation and in-hospital logistics of chemotherapy and biological medicines were rated positively. Workflow disruptions occurred during peak hours, highlighting the importance of prioritizing preparation according to the medication administration sequence. Information on hazardous drug handling, medication safety, storage, administration, and waste management was evaluated positively, while a need for more structured training was identified.

Conclusion and Relevance The survey identified key areas for improvement in oncology pharmacy services. Lowest satisfaction was related to BD Cato, while communication and logistics received the highest ratings. Following the survey, collaboration with clinical departments has increased and future actions will focus on improving BD Cato usability through structured protocol updates and targeted user training.

Background and Importance Documentation accuracy is essential to ensure data integrity and patient safety in oncology clinical trials. Gaps in documentation may compromise compliance with Good Clinical Practice (GCP) and increase regulatory risk. Oncology pharmacists can expand their role beyond dispensing activities by performing non-traditional patient monitoring through structured verification of clinical trial documentation. However, real-world data describing the frequency and nature of documentation gaps identified through pharmacist-led review remain limited.

Materials and Methods A retrospective descriptive study was conducted at an oncology clinical research center. Documentation gaps identified during pharmacist-led daily review of patient encounters (n = 9157) in 2025 were recorded in a structured database, totaling 6149 findings. Findings were classified by type and mapped to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate), including documentation related to clinical assessment and administrative trial processes. Only detection activities were analyzed.

Results Overall, 47.57% of patient encounters contained at least one documentation gap identified during structured review. The ALCOA domains most frequently affected were Contemporaneous and Accurate. The most common findings were incomplete adverse event documentation (18.4%), adverse events without appropriate registration (15%), and adverse events without documented follow-up (12.4%). Administrative coordination-related findings represented 11% of observations, and 2.6% of visits occurred outside the protocol-defined window. Most gaps involved documentation from clinical assessments, particularly regarding completeness and timing of adverse event information. These patterns indicate documentation as a relevant source of operational and regulatory risk. Pharmacist-led review enabled systematic identification of recurrent gaps and represents a non-traditional form of clinical monitoring, providing structured insight into toxicity documentation and potential drug-related risks.

Conclusion and Relevance Pharmacist-led documentation review enables structured identification of documentation gaps in sponsored oncology clinical trials while contributing to patient monitoring. Applying ALCOA principles supports risk-oriented analysis and strengthens the pharmacist’s role in data integrity, safety evaluation, and regulatory compliance.

Background and Importance Preparation of cytotoxic medication is a high-risk hospital process requiring strict control to ensure patient safety, product sterility, dose accuracy, and occupational protection.Compounding workflows remain vulnerable to latent system failures that may compromise safety.Proactive risk-analysis tools like Failure Mode and Effects Analysis are recommended for evaluating complex healthcare processes.Objectives: To identify potential failure modes in chemotherapy compounding workflows and prioritize risks using a structured FMEA approach.

Materials and Methods A process-based risk assessment was conducted on the cytotoxic preparation circuit, including prescription validation, material preparation, aseptic compounding, labeling, transport, and delivery. Each step was mapped and analyzed using FMEA methodology. Potential failure modes, causes, and consequences were identified through multidisciplinary evaluation. Severity, occurrence, and detectability scores were assigned according to standardized risk- analysis scales, and Risk Priority Numbers (RPNs) were calculated to rank critical steps requiring corrective measures.

Results The analysis identified multiple potential failure points distributed across technical, organizational, and human-factor domains. High-priority risks were primarily associated with prescription validation accuracy, environmental preparation conditions, labeling verification, and workflow interruptions during aseptic compounding. The structured scoring system enabled prioritization of corrective actions and highlighted steps where preventive strategies could most effectively reduce overall risk. Limitations include dependence on expert scoring and variability between institutional practices.

Conclusion and Relevance FMEA represents a powerful proactive tool for identifying vulnerabilities in chemotherapy preparation systems and prioritizing safety interventions. Integrating structured risk analysis into routine oncology pharmacy practice may enhance process reliability, reduce medication-error risk, and strengthen quality assurance programs.

Background and Importance Excessive waiting time remains a frequent operational challenge in oncology units and negatively affects patient experience, stress levels, and workflow efficiency. Delays often arise from complex multistep medication pathways requiring coordination between medical, pharmacy, and nursing teams.

Aim and Objectives To identify key operational determinants of chemotherapy waiting time and propose evidence-based strategies to improve workflow performance while maintaining medication safety.

Materials and Methods A structured workflow assessment of chemotherapy processes was conducted using standard oncology hospital practice models. Each step of the medication pathway - from consultation and prescription to pharmaceutical validation, aseptic compounding, transport, and administration - was mapped. Bottlenecks described in institutional reports and oncology pharmacy practice literature were analyzed, and optimization strategies were derived from process-improvement principles.

Results Five major contributors to delays were identified: late prescription transmission, sequential interprofessional steps, absence of regimen prevalidation, variability in chair and nursing availability, and transport delays. Evidence from institutional experiences indicates that early electronic prescribing, protocol prevalidation, batching of standard regimens, structured communication tools, and scheduled delivery rounds significantly improve workflow predictability and reduce delays.

Conclusion and Relevance Chemotherapy waiting time is primarily driven by modifiable operational factors. Structured workflow redesign and anticipatory coordination strategies represent feasible and transferable solutions for oncology centers seeking to improve efficiency and patient satisfaction.

Background and Importance In the last decade, a new structural group of anti-cancer drugs has appeared among the drugs approved by the European Medicines Agency, namely antibody-drug conjugates. Their appearance and spread in oncology and hematology therapies have brought a real paradigm shift in the treatment of cancer diseases. This treatment -which is combined in itself-is effective in hematopoietic tumors and solid tumors because it combines the targeting of antibodies with the power of cytotoxic agents, minimizing systemic toxicity. In Hungary, they are financed on the basis of a specific permit.

Materials and Methods The aim of my study is to show how the use of ADCs has changed in the past 10 years at the Jósa András Hospital based on the infusions produced in the Cytostatic Laboratory. What are the trends of the three ADC therapies used in breast cancer patients in recent years in our Institution. I prepared a retrospective analysis based on the manufactured infusions by processing data extracted from the CATO software between 2015-2025. I collected the data of oncology patients from the Hospital's IT system.

Results A total of 49 hematology patients received some ADC treatment between 2020 and 2025. Most patients received brentuximab vedotin therapy. A total of 97 oncology patients received any ADC therapy between 2015 and 2025, of which 96 patients in the breast cancer indication and 1 in the urothelial carcinoma indication. Among breast cancer patients, 6 patients received two types of ADC therapy separated in time. Among breast cancer patients, it can be observed that the number of new patients receiving trastuzumab deruxtecan increased significantly in 2025, from 2 patients to 19. The number of new patients receiving trastuzumab emtansine has been increasing continuously since 2023. The number of new patients receiving sacituzumab govitecan therapy decreased from 7 to 3. Based on HER2 status, the medical history of patients receiving trastuzumab deruxtecan was examined, 9 patients had score3, 10 patients had score2 - 8 of which were FISH negative - and 4 patients were score1.

Conclusion and Relevance The ESMO Metastatic Breast Cancer Living Guideline v1.2 April 2025. extended the use of trastuzumab deruxtecan to patients with hormone receptor positive/HER2-negative metastatic breast cancer. Accordingly, the use of this drug in our Hospital has increased. Its approval in earlier therapeutic lines and easier access to ADCs would be beneficial in terms of tumor resistance and patient tolerance.

Background and Importance Cancer treatment is complex and emotional challenge that requires a multidisciplinary approach in which hospital pharmacy plays a central role in optimising therapy, safety and personalised follow-up. In our centre, cytostatic preparations were previously compounded in the central pharmacy and transported to the Oncology and Haematology Day Hospital (OHDH), leading to delays, prolonged patient stays and workflow inefficiencies. This project aimed to improve safety, effectiveness and patient experience through the integration of pharmacists and an on-site clean room within the OHDH.

Materials and Methods A multidisciplinary working group co-designed a new OHDH that incorporated a certified clean room (IIb class) with a biological safety cabinet, medication storage and pharmacist offices. Protocols for scheduling, stock management and treatment validation were updated. Limitations such as reduced refrigeration capacity and the certification process of the preparation room were managed through planning and phased implementation. Pharmaceutical activity and interventions were analysed from 2 December 2024 to 1 December 2025 and compared with the equivalent pre-implementation period.

Results A total of 382 pharmaceutical interventions (PIs) were recorded. In the pre-implementation period (n=29), PIs were mainly reactive, focusing on safety (31.0%) particularly dose adjustments due to toxicity and others (20.7%), including compounding errors. Following the on-site integration (n=353), documented PIs increased by 1,117%. The clinical profile shifted significantly: Indication (53.0%) became the leading category through proactive protocol and scheduling corrections. Safety (21.0%) evolved toward real-time monitoring, such as same-day creatinine updates for AUC-based dosing. Others (15.3%) reflected a new focus on sustainability, with systematic re-utilization of high-cost biologics from cancellations. Effectiveness (10.8%) improved through precise weight-based dosing and optimized supportive care. The on-site pharmacy reduced waiting times and enhanced multidisciplinary synergy. Underreporting of interventions due to routine workload was identified as a limitation.

Conclusion and Relevance Integrating the pharmacy into the OHDH transformed the service into a strategic clinical partner. Moving from correcting logistical errors to proactive clinical optimization proves that physical proximity enhances care quality, safety, and economic efficiency. This feasible and transferable model offers a replicable approach to optimizing oncology services in any center with adequate space.

Background and Importance The circadian rhythm modulates immune function, and preclinical evidence suggests that the timing of immune checkpoint inhibitor (ICI) administration may affect antitumor efficacy. The biological clock controls genes which regulate the activation and infiltration of CD8+ T lymphocytes in the tumor microenvironment, as well as the expression of Programmed Death-1 (PD-1) and Programmed Death-Ligand 1 (PD-L1). Administering ICIs during the period of highest immune activity, usually in the morning, which coincides with the peak recruitment of T lymphocytes, may enhance the response to these drugs.

Materials and Methods Assessment of the association between the administration time of an ICI - pembrolizumab and overall survival (OS), progression-free survival (PFS), and immune-mediated adverse events (imAEs). Systematic review conducted in January 2026 according to the PRISMA 2020 guidelines, in the PubMed, Embase, Web of Science databases and publications from ASCO and ESMO using the MeSH terms: Pembrolizumab, circadian rhythm, chronotherapy. The studies classified the timing of administration as “early in the day” and “afternoon/evening,” with cohort time points ranging from 11:00 a.m. to 4:30 p.m.

Results Most observational studies suggest that starting immunotherapy infusion earlier in the day is associated with better clinical outcomes. In non-small cell lung carcinoma (NSCLC), the first administration of pembrolizumab before 11:00 AM was associated with longer median OS compared to administration after 11:00 AM (43.7 vs. 32.4 months; HR 0.67; 95% CI 0.46-0.97; p=0.03), with no significant difference in PFS. Studies in patients with melanoma treated after 4:30 PM showed worse OS outcomes (HR 1.31; 95% CI 1.00-1.71; p=0.046). A pan-tumor study found that morning administrations (before 11:00 AM) in patients with performance status (PS) 0-1 resulted in longer OS (median 36.7 vs. 21.3 months; p=0.023), higher partial/complete response rates (58% vs. 41%; p=0.027), and a higher incidence of grade 1-3 adverse events (49% vs. 34%; p=0.028).

Conclusion and Relevance Retrospective studies suggest that morning administration of pembrolizumab may be associated with improved OS, especially in patients with good PS, although with a higher incidence of severe imAES. Within the scope of this review, the pharmacy service, in cooperation with the medical team, reorganized pembrolizumab administration schedules, with these now preferably scheduled before 11:00 AM.

Background and Importance The Chemotherapy Review Clinic (CRC) at National Cancer Centre Singapore manages patients who experienced treatment related complications or adverse effects requiring urgent medications like antibiotics. These drugs are supplied by satellite pharmacists at the Medication Services@Clinics (MSC). The median waiting time for medication supply was 22 minutes with longer wait during MSC lunch closures. Beyond pharmacy, patients also had to wait up to 45 minutes for medication administration. To reduce the waiting time for urgent medication supply by 50%, a quality improvement project was initiated.

Materials and Methods A multidisciplinary team was formed in July 2024 and identified the inaccessibility to urgent medications as the root cause. Using the Plan-Do-Study-Act (PDSA) approach, in PDSA cycle 1, a common communication channel was created on Microsoft Teams for nurses to alert the central pharmacy for any medication orders to review and dispense during MSC closure. In PDSA cycle 2, MSC pharmacists will provide CRC nurses with a daily drug bin of ten commonly used medications. For any urgent orders, nurses will notify MSC pharmacists via the same platform for review before retrieving the medications.

Results A total of 74 cases were reviewed in PDSA 1. The median waiting time decrease from 22 minutes to 15 minutes. Further improvement was observed in PDSA 2, which served 250 patients. The median time to dispensing decreased to 4 minutes while the median time to medication administration was reduced to 8.3 minutes. The streamlining of communication between nursing and pharmacy coupled with the increase accessibility to medications had significantly reduced the time to administration of urgent medications for CRC patients. The drug bin improves medication accessibility but remains a manual system compared with commercially available medication cabinets. To reduce medication errors, measures such as limiting the number of medications, adopting of tall-man lettering on medication labels and using of compartmental trays to store the medications were implemented. Nevertheless, implementation remains inexpensive and straightforward, given that technological infrastructure is not required.

Conclusion and Relevance This project has achieved its aim of reducing the waiting time for urgent medication supply for CRC patients by 50%. It serves as a proof of concept that medication accessibility at ambulatory clinics is crucial for the delivery of quality and efficient care towards patients. Additional research is required to assess the sustainability and scalability of the study.

Background and Importance In advanced cancer care, medication safety relies on centralized chemotherapy production and integrated digital infrastructures. At our Comprehensive Cancer Center, an RFID-supported system links compounding and bedside administration, creating a consolidated safety barrier. Analysis of incident reporting data (2023–2025) identified medication-related events as the leading category (26%), prompting a multidisciplinary initiative to strengthen governance across the medication-use pathway. The aim was to map the process, identify high-risk steps, and support targeted improvements

Materials and Methods A multidisciplinary team was established, involving hospital pharmacists, oncologists, nurses, and an IT systems advisor, with the Risk Management and Quality Unit acting as methodological facilitator and process expert. Ten structured, multidisciplinary sessions (May–December 2025) enabled comprehensive mapping of the medication-use process and identification of high-risk steps. Risk analysis was conducted using Healthcare Failure Mode and Effects and Criticality Analysis (HFMECA), integrating incident reporting data with national regulatory and internationally recognized standards

Results Between 2023–2025, 194 incidents were reported; 51 were medication-related (9 in 2023, 22 in 2024, 20 in 2025). Most events occurred during administration (n=30), followed by prescribing (n=15), preparation (n=5), and storage (n=1). Forty-nine subprocesses were mapped, and 15 high-risk steps were identified, leading to 7 corrective actions. Combining reactive monitoring and HFMECA enabled granular mapping of the pathway, including micro-phases and decision nodes. Major vulnerabilities included reconciliation practices, interoperability between clinical and chemotherapy software, allergy documentation, prescribing governance, labelling inconsistencies, and traceability of compounded preparations. Most events were intercepted at administration, although several originated upstream, underscoring phase interdependence. Participation was representative but not exhaustive of all professionals involved in the pathway

Conclusion and Relevance Integrating proactive and reactive tools strengthened shared accountability and fostered interprofessional solutions. The integration of technological safeguards and governance enhanced reliability, reflected by increased reporting and growing safety awareness. This structured approach offers a transferable framework for sustainable system redesign and continuous quality improvement.

Background and Importance Cancer chemotherapy is a treatment that systematically kills rapidly dividing cancer cells but also causes expected side effects, collectively known as chemotherapy-induced toxicities. These toxicities range from mild to life-threatening and may affect multiple organ systems, including the hematologic and gastrointestinal systems. They are managed and prevented using supportive care medications prescribed before, during, and after chemotherapy administration. This study aimed to determine the prescription patterns of supportive care medications at a major referral hospital in Tanzania

Materials and Methods A hospital-based descriptive cross-sectional study was conducted at Bugando Medical Centre (BMC), a tertiary referral and university teaching hospital serving the Lake Zone of Tanzania. The study analyzed 104 prescription slips of pediatric cancer patients receiving outpatient chemotherapy between January and December 2023. National treatment guidelines and disease-specific protocols were also reviewed. Data were extracted using structured checklists, cleaned in Microsoft Excel, analyzed in STATA version 15, and summarized as frequencies and percentages for descriptive statistical analysis.

Results A total of 104 pediatric chemotherapy prescriptions were analyzed. Ondansetron (84.6%) and pre-hydration with normal saline (20.2%) were the most commonly prescribed pre- chemotherapy supportive medications, while oral ondansetron (80.8%) and post-hydration normal saline (22.1%) predominated after chemotherapy. Few prescriptions included comprehensive antiemetic combinations for multi-agent regimens. National cancer treatment guidelines provided limited direction on supportive care, leaving decisions largely to clinicians, whereas disease-specific protocols offered clearer recommendations. Although prescribing generally aligned with common toxicity prevention, inconsistencies were observed in antiemetic use for moderate- and high-emetogenic regimens. These findings highlight the need for standardized, evidence-based supportive care guidelines tailored to resource-limited pediatric oncology settings.

Conclusion and Relevance The majority of patients were prescribed supportive care medication to prevent and manage the side effects of chemotherapy treatment based on the available treatment guidelines and disease-specific protocols. However, many of these documents contain little to no information on the best prescriptions of supportive care medications.

Background and Importance The implementation of a clinical trial (CT) is a rigorous and complex process, with participant safety as its primary concern. The safety requirement, embedded within a constantly evolving framework, applies particularly to the investigational medicinal product (IMP) circuit. The management of IMPs within hospital pharmacies requires expertise and constant vigilance. Given that CTs are inherently high-risk, procedural heterogeneity can lead to situations prone to medication errors (ME). Our study aims to identify and analyse ME risk situations related to sponsor processes in CTs.

Materials and Methods This survey is a retrospective cross-sectional observational study aimed at collecting feedback from hospital pharmacists working on CTs across France. For each step of the CT circuit, a list of potential failures was set. The form consisted of items where the frequency of occurrence was rated on a 5-level scale. Respondents were asked to rate the frequency of ME risk situations of each item (Never, < or > once per month, > once per week). Qualitative variables are expressed as percentages (n=number). We present results for the reception, storage and preparation/administration steps.

Results The form was sent to 93 pharmacists across 46 healthcare facilities in France, and 30 working on CTs responded. Overall, ME risk situations occurred less than once per month in 42%, more than once per month in 26%, more than once per week in 17% and never in 14%. At the reception step (6 items, 180 replies), 47% (n=14) of respondents reported receiving multiple dosages with similar labels in a single order more than once per week. Short expiration dates and lack of mandatory documents occurred more than once per month for 47% (n=14) and 33% (n=10). Storage (3 items, 90 replies) was the best-controlled step, with 33% of situations never occurring and no responses indicating a frequency greater than once per week. The preparation step (5 items, 150 replies) compiled the most critical risks: short stability (<4h), two different dosages for the same drug and IMP-medical device incompatibilities occurred more than once per week for 40% (n=12), 37% (n=11), and 27% (n=8), respectively.

Conclusion and Relevance This survey overviews ME risk situations, raising awareness among PharmD about critical steps in the CT circuit. Preparation step emerged as the most critical at-risk, notably due to short stability, multiple dosages, and device incompatibilities. These findings support dialogue with sponsors to implement fitting preventive measures to be identified and secured before the study initiation visit.

Background and Importance Preparing cytotoxic drugs in oncology pharmacy is high-risk, with potential errors and occupational exposure, requiring strict adherence to international safety standards. Organizations like the European Society of Oncology Pharmacy stress standardized practices. Traditional training often lacks engagement, while gamification provides an innovative way to enhance active learning and retention.

Aim and Objectives To develop and validate an interactive educational card game to improve memorization, risk recognition, and adherence to cytotoxic handling guidelines among hospital pharmacy professionals.

Materials and Methods A pedagogical study in a hospital oncology pharmacy analyzed international guidelines to identify critical safety checkpoints in five domains: environment, personal protective equipment, preparation process, common errors, and quality assurance. A 30-card educational game was developed, including good practice, error simulation, and safety reinforcement cards, each with a rule, rationale, and risk. Designed for small-group workshops, it uses scenario- based learning and peer discussion with minimal resources.

Results The card-based system simulates real-world cytotoxic preparation scenarios and supports identification of high-risk practices in a safe learning environment. Its gamified format encourages active engagement, teamwork, and reinforcement of key safety steps. Low-cost and reproducible, it is adaptable to various hospital settings, including resource-limited contexts. By transforming guidelines into interactive learning, it may improve retention, adherence to safety standards, and safety culture in oncology pharmacy practice. Further studies are needed to assess its impact on error reduction and long-term knowledge retention.

Conclusion and Relevance The development of a serious educational card game offers an innovative strategy to reinforce cytotoxic handling guidelines in hospital pharmacy. By turning safety instructions into an interactive tool, it enhances memorization, boosts professional engagement, and may improve compliance and reduce medication errors.

Background and Importance Secure monitoring of nitrogen tanks through an automated cryogenic room management system (ACRMS) is essential to ensure compliant storage of advanced therapy medicinal products (ATMPs). Alarms related to temperature variation, nitrogen level decrease or malfunction require rapid standardized responses to preserve product integrity and patient safety. Interpreting alarm scenarios during on-call duty may generate uncertainty. This work aimed to develop an artificial intelligence (AI)-assisted interactive decision-support flowchart to standardize management of nitrogen tank alarms used for ATMP.

Materials and Methods A specific standard operating procedure (SOP) for ACRMS monitoring and alarm management during on-call duty was developed and validated by unit pharmacists and the quality coordinator. The SOP was first translated into structured code using an AI tool (ChatGPT). A second AI platform (Lovable) was then used to design a dynamic decision-tree interface and generate an interactive web-based flowchart. Usability of the tool was assessed by pharmacists involved in the on-call rotation using a five-point Likert scale (1 very difficult to use; 5 very easy and intuitive).

Results The first AI tool initiated transcription of the SOP into structured code. Most development was performed with the second AI platform, which optimized the decision-tree architecture and generated a dynamic flowchart displayed as an ergonomic website. The interface reproduces procedural pathways according to alarm scenarios while remaining aligned with the validated SOP. The application guides users step by step through the decision process, reducing interpretation variability and enabling rapid responses during on-call duty. The tool is accessible in real time from institutional computers and smartphones: https://stepwise-guidance- 17568.lovable.app/. User evaluation showed very high satisfaction. Seven of eleven pharmacists completed the assessment. Interface clarity, step comprehension and navigation fluidity all received the maximum Likert score. Decision speed and support for selecting the appropriate action were highly rated (5/5), and no usability issues were reported.

Conclusion and Relevance Integration of AI transformed a static SOP into an interactive decision-support tool for standardized management of ACRMS alarms. This approach reduces uncertainty during on-call interventions and improves safety for ATMP storage. Ongoing evaluation will provide

consolidated results. The model could be extended to other high-risk processes in hospital pharmacy.

Background and Importance Therapy confirmation in oncology is a critical step in the care pathway. Although prescribing software ensures protocol validation and safe administration, residual organisational inefficiencies, paper-based processes, and informal communication may still lead to transcription errors, misinterpretations and potential economic waste.

Aim and Objectives To improve the workflow of therapy confirmation in an oncology day hospital and compounding laboratory, reducing errors, interruptions and non-value-added activities, and enhancing coordination between healthcare professionals.

Materials and Methods A root cause analysis based on the 5 Whys method identified manual transcription, fragmented communication and frequent interruptions as the main sources of inefficiency. Nursing staff feedback informed process design. A shared Excel Online workflow was developed with mandatory fields, standardised data entry, real-time access and traceability through institutional credentials. Therapies were organised into predefined time slots according to protocol characteristics, supporting coordination between the oncology day hospital, the compounding laboratory and subcutaneous administration pathways.

Results The workflow was implemented in a setting managing approximately 100 daily preparations across four oncology day hospitals, with 55% of activity concentrated in the main centre hosting the compounding laboratory. Peak workload on specific days was identified as a key risk factor for inefficiencies and patient delays. The implementation reduced transcription and communication-related errors, decreased interruptions for healthcare professionals, and improved coordination between clinical and pharmaceutical units. It also supported the integration of subcutaneous administration pathways, enabling more efficient organisation and high-throughput treatments. Overall, the intervention shifted activities from non-value-added to value-added time in line with lean principles. Preliminary qualitative feedback suggested improved workflow efficiency and perceived reduction in waiting times. The main limitation is the absence of formal quantitative pre–post analysis.

Conclusion and Relevance A zero-cost digital workflow integrated with existing prescribing systems can improve organization, safety and efficiency in oncology settings. This scalable model enhances patient- centred care and supports subcutaneous treatment pathways. Future work will include quantitative evaluation of waiting times and patient satisfaction using structured questionnaires.

Background and Importance Drugcam® is a video-based system supporting the preparation of injectable anticancer drugs. Recently implemented in our compounding unit, it was used in up to 75% of preparations in 2025. While it enhances process safety, its integration introduces new risks, requiring adaptation of the quality management system in accordance with regulatory guidelines. This study aimed to identify and map risks associated with anticancer drug preparation integrating Drugcam® in our workflow.

Materials and Methods A risk mapping of the Drugcam®-integrated preparation process was conducted using Failure Mode and Effects Analysis (FMEA), in accordance with ICH Q9(R1). The process was structured into sequential steps, functions, and potential failure modes. Each failure mode was scored (severity, occurrence, detectability) to prioritize risks and define corrective actions. The risk analysis was performed by a panel comprising three pharmacists, two pharmacy students, and three pharmacy technicians. The individual questionnaire responses were subsequently consolidated to generate a unified risk rating.

Results The process was divided into 10 steps, including 43 functions, leading to the identification of 60 failure modes. Risk analysis highlighted 2 major and 11 moderate failure modes. The most critical risks identified were the selection of an incorrect anticancer vial and the use of an inappropriate infusion set, for bag preparations. While Drugcam® ensures vial verification before sampling, it does not control the sampling act itself or the infusion set selection, leaving residual risks of error. These failure modes are not directly inherent to the system but are mainly related to human factors. Consequences include production delays when detected and potential medication errors with clinical impact if undetected. To mitigate these risks, corrective measures were proposed, including workspace reorganization. An upgrade to the Drugcam® technology is under evaluation for implementation of a verification system for infusion sets.

Conclusion and Relevance The integration of AI-based systems such as Drugcam® requires a comprehensive understanding of processes to ensure effective risk management. This study provides a structured basis for identifying and reducing risks in anticancer drug preparation and supports the implementation of targeted corrective actions for high-risk medications.

Background and Importance The preparation of investigational medicinal products (IMPs) in hospital pharmacies requires high accuracy, traceability, and compliance with GCP and GMP. Manual compounding may introduce variability and increase the risk of errors, especially for complex multi-component preparations. Digital technologies and automated verification systems can support process standardization and risk reduction. This study describes the implementation of a camera- assisted compounding device integrated into a fully digital workflow and evaluates its impact on standardization, traceability, safety, and efficiency

Materials and Methods A camera-assisted compounding system with integrated cameras and IT devices was implemented in a hospital pharmacy for clinical trial drug preparation. The system enables automated recognition of investigational products, diluents, and materials, guiding pharmacists through reconstitution, dilution, and verification steps within a GMP-compliant workflow. Features include real-time visual verification, double-operator control, and full digital traceability. A retrospective pre–post analysis compared manual and digital workflows, evaluating preparation time, error rates, documentation completene

Results Between January 2023 and January 2025, more than 20,000 IMP preparations were performed using the camera-assisted system, corresponding to approximately 600 preparations per month. Following implementation of the digital workflow: • the average preparation time decreased from approximately 18 minutes to 10 minutes per preparation, representing a reduction of about 45% • operator-related preparation errors decreased from 1.5% to 0.4% • traceability compliance increased from 92% to 100%, due to automated recording of preparation steps and digital documentation of operator verification. The automated recognition of IMP vials, diluents, infusion bags and consumables improved process standardization and reduced variability between operators. In addition, the digital workflow improved audit readiness, facilitating documentation review during clinical trial monitoring and inspections.

Conclusion and Relevance The implementation of a camera-assisted compounding system within a digital workflow improved standardization, traceability, and efficiency in IMP preparation. Real-time verification, automated recognition, and double-operator control reduced errors and enhanced risk mitigation. This scalable model supports GCP/GMP compliance and improves patient safety in clinical research settings.

Background and Importance The growing use of oral anticancer therapies (OATs) has shifted a substantial portion of cancer treatment to the home setting, increasing the need for structured procedures to ensure adherence, safe medication use, timely pharmacovigilance, and coordinated multidisciplinary care. We conducted a mapping and benchmarking assessment of organizational and clinical– pharmacological management across oncology centres in the Veneto Region, describing the current state, identifying variability and gaps across key domains, and defining priorities for harmonization and shared technical standards.

Materials and Methods A cross-sectional assessment was performed using a validated multidisciplinary web-based questionnaire developed in collaboration with the Regional Coordination for Oncological Activities. The survey explored eight domains related to organizational and clinical– pharmacological management of OATs and was administered to oncology, hematology, and hospital pharmacy units. Descriptive analyses summarized adherence to requirements and recurrent themes from open-ended responses.

Results Fourteen centers participated. Procedural formalization was high, but variability persisted in OAT management. Medication reconciliation (57%) and pharmacological counseling were implemented with heterogeneous approaches. Although electronic medical records were widely adopted (93%), digital tools supporting healthcare continuity were limited, with telemedicine or telepharmacy active in six centers. All centers had procedures for adverse drug reaction reporting; however, active pharmacovigilance, patient engagement, and therapeutic drug monitoring were inconsistently developed. Error-prevention procedures were formalized in 79%, with gaps in risk management and remote monitoring. Governance of high-cost drugs included horizon scanning and deblistering when required.

Conclusion and Relevance The assessment revealed heterogeneous workflows and tools, indicating the need for shared technical standards to improve reconciliation, counseling, digital coordination, and safety monitoring in home-managed OATs. As many processes rely on high-level recommendations translated into local procedures, similar variability is expected elsewhere.

Background and Importance Adherence to oral targeted therapies represents a major challenge in oncology, as it directly determines treatment efficacy. However, patient-related or healthcare system-related factors can compromise this adherence. The objective of this study is to evaluate medication adherence to ribociclib in patients with locally advanced or metastatic breast cancer.

Materials and Methods This is a retrospective descriptive study conducted at the Salah Azaiz Institute from January 2024 to July 2025. All indigent patients enrolled in the ACCESS program who received at least one cycle of ribociclib during this period were included. Demographic and clinical data, as well as refill dates, were collected from patient records, prescriptions, and the STKMED software, which also provided supply data and stockouts to interpret instances of non-adherence. Therapeutic adherence was assessed by calculating the Proportion of Days Covered (PDC), using a threshold of 80% to define adherence.

Results A total of 56 patients with Stage IV breast cancer were studied, with a mean age of 54 years [34– 76]. A female predominance was noted (F/M sex ratio = 27). Regarding therapeutic adherence, only 14% (n=8) were adherent (mean PDC = 90%), while 86% (n=48) were non-adherent (mean PDC = 35.6%). Among the latter, 45% (n=22) were non-compliant due to patient-related factors: forgetfulness, polypharmacy, adverse effects, or lack of perceived benefit. Furthermore, 39% (n=19) were lost to follow-up, likely related to disease progression, complications, death, or barriers to healthcare access. Unfortunately, non-adherence in 14% (n=7) of patients was directly linked to documented stockout periods between February 2025 and May 2025.

Conclusion and Relevance Adherence to ribociclib, already compromised by patient-related factors, is further exacerbated by supply shortages, highlighting the urgent need for corrective strategies.

Background and Importance HPLC-UV is a validated method for drug analysis but is labor-intensive and less suited for rapid in-process control of small volume samples. UV/Vis spectroscopy (DrugLog®) offers fast trans- mission-fingerprinting and may serve as a practical alternative for routine checks in compounding. Objective: To assess whether DrugLog® UV/Vis can be considered acceptable for both identity and concentration assessment when benchmarked against HPLC-UV/VIS, and whether it is suitable for small-volume samples of our 4 compounded preparations.

Materials and Methods Carboplatin, doxorubicin, 5-fluorouracil (5-FU) and gemcitabine were analyzed by UV/Vis (DrugLog®; transmission fingerprints) and by HPLC-UV (chromatographic separation with UV detection) respectively. Calibration series were prepared in 0.9% NaCl and/or 5% glucose depending on the workflow. Linearity/correlation was evaluated from transmission-vs.- concentration calibration data. Validation metrics (precision as %RSD; accuracy/recovery) were compiled from replicate measurements. Method agreement was assessed using correlation between UV/Vis and HPLC-UV values.

Results DrugLog® provided clear drug-specific spectral signatures enabling qualitative identification of all analytes. Transmission-based calibration yielded high correlation across the investigated ranges, with minor curvature for weakly absorbing compounds: carboplatin R²=0.96 (0–80 μg/mL), doxorubicin R²=0.99 (10–70 μg/mL), 5-FU R²=0.96 (20–200 μg/mL) and gemcitabine R²=0.98 (10–100 μg/mL). HPLC-UV calibration showed consistently high linearity (typically R²≈0.99). Precision and recovery were within typical acceptance criteria (e.g. UV/Vis %RSD around 1–2% and recoveries within ~95–105%; carboplatin ~1.08% RSD and ~98.5% recovery; doxorubicin ~1.5% RSD and ~98.9% recovery; 5-FU ~1.8% RSD and ~97.3% recovery; gemcitabine ~2.0% RSD and ~96.2% recovery). Glucose matrices exhibited pronounced batch- dependent spectral variability and additional non-analyte peaks, indicating matrix interference and limited transferability of calibrations; re-calibration was required for each new glucose batch.

Conclusion and Relevance Compared with HPLC-UV, DrugLog® demonstrates robust qualitative identification and strong quantitative correlation for our 4 cytotoxic drugs, supporting its acceptance for concentration assessment in routine compounding. It is particularly useful for small-volume preparations where rapid, low-volume in-process control is beneficial. Matrix effects (notably glucose) remain the key limitation.

Background and Importance The preparation of intravenous chemotherapy is a complex, high-risk process, with potential issues including dosing errors, contamination, and occupational exposure to cytotoxic agents. Robotic compounding systems represent an innovative approach to improving patient and operator safety while ensuring standardization and traceability. This study evaluates the impact of robotic automation on preparation accuracy and safety, with particular attention to the evolving role of the hospital pharmacist in process governance.

Materials and Methods A retrospective observational study was conducted at the National Cancer Institute of Milan (2024–2025). Approximately 230 daily preparations for 140 patients were analyzed, one-third performed using a robotic system. Outcomes included dosing accuracy, preparation errors, traceability, turnaround time, and occupational exposure. The system is integrated into the clinical workflow, enabling automated drug and container recognition and accurate compounding according to validated prescriptions. The pharmacist performs clinical validation, process oversight, and final barcode verification.

Results Robotic compounding significantly improved dosing accuracy and reduced preparation errors compared with manual compounding. Although an acceptable deviation range of ±5% is defined, robotic preparations consistently remained within ±1%, demonstrating high precision and reproducibility. In contrast, manual compounding, while compliant with acceptance criteria, showed greater variability and higher error rates. Occupational exposure to cytotoxic agents was markedly reduced due to the closed-system design. Enhanced traceability and standardization enabled continuous monitoring, complete documentation, and strengthened audit and quality assurance processes. Furthermore, continuous automated production improved workflow continuity and operational efficiency. Within this framework, the hospital pharmacist plays a pivotal role in clinical validation, technical oversight, and therapeutic appropriateness, acting as a key interface between automation technologies and patient safety.

Conclusion and Relevance Robotic systems substantially enhance safety, accuracy, and traceability in chemotherapy preparation, reducing variability and compounding errors. Their integration with the clinical expertise of the hospital pharmacist optimizes the entire process and ensures high standards of care, reaffirming the pharmacist’s central role in the safe implementation of advanced technologies in oncology.

Background and Importance Environmental contamination from pharmaceutical waste represents a major public health challenge due to its persistent effects on ecosystems and environmental microbiology. Hospital activities, particularly the preparation of anticancer drugs, generate cytotoxic residues with significant ecological impact. In this context, green pharmacy promotes sustainable practices aimed at reducing such emissions. However, the absence of standardized tools limits the systematic evaluation of the environmental performance of preparation units.

Materials and Methods A literature review was conducted via PubMed, Scopus and ScienceDirect using keywords related to green pharmacy, cytotoxic waste management and environmental auditing tools. International recommendations issued by the World Health Organization, the European Commission and the Organisation for Economic Co-operation and Development, as well as relevant publications, were reviewed to identify management standards, safe disposal modalities and source reduction strategies. These data were used to design a structured environmental audit grid adapted to Antineoplastic preparation units.

Results The audit grid was structured according to a life-cycle approach covering prevention, management, treatment, and training. It includes five domains: (1) organizational and environmental policy, (2) cytotoxic waste management, (3) waste reduction, (4) safe segregation and disposal, and (5) training and continuous improvement. Each domain is assessed on a 0–3 scale reflecting compliance with international recommendations. The overall score, obtained by summing categories, uses qualitative indicators to classify units by environmental performance and identify improvement areas. The audit verifies strict segregation, storage in rigid labeled containers, and prohibition of sewage discharge. Destruction options include dual-chamber incineration ≥1200 °C with flue gas treatment, authorized co-incineration in cement plants, or encapsulation with secure landfill disposal. The grid also integrates packaging optimization, improved segregation, collection systems, and staff training.

Conclusion and Relevance The environmental audit grid provides a standardized basis for evaluating pharmaceutical waste management practices in cytotoxic preparation units. It will serve to plan sustainable actions and measure progress. Future application of the tool will enable collection of comparative scores and guide continuous improvement.

Background and Importance Experimental oncology clinical trials are based on detailed and stringent protocols defining dosing regimens, adverse event monitoring, and treatment adherence. In this context, the management of oral anticancer drugs is critical to ensure safety and efficacy, representing a complex challenge in terms of prescribing appropriateness. Computerized systems can support hospital pharmacists in process control and prescription verification, enhancing the overall quality of care.

Materials and Methods The computerized system used at the IRCCS National Cancer Institute of Milan for managing oral anticancer drugs in clinical trials was analyzed. Based on the protocol and pharmacy manual, pharmacists prepare drug labels, entering and updating dose and posology, including protocol amendments. In experimental protocols, particularly phase I studies, accurate dose level definition is essential. The system standardizes terminology, reducing interpretation errors and improving process quality.

Results The dispensing of oral drugs in clinical trial settings has been facilitated by the use of a computerized system. Key prescription data, including randomization number, treatment cycle, dose, and posology, are easily accessible and verifiable. The system enables a rapid and structured control, facilitating comparison with the patient’s treatment history and supporting the pharmacist in verifying consistency between medical prescriptions and drug labels. Timely updates of drug labels following clinical changes or protocol amendments improve protocol adherence. In addition, the pharmacist performs a double-check between the prescribed dose and the number of packs to be dispensed, ensuring full treatment cycle coverage. In case of discrepancies, review of the treatment history allows identification of prior dose reductions; if not justified, the physician is contacted for confirmation.

Conclusion and Relevance The computerized system optimizes drug management in clinical trials by improving traceability, prescription control, and therapeutic appropriateness. Integration between medical prescribing and pharmacist verification ensures a safer and more efficient process, with a positive impact on treatment quality and protocol adherence.

Background and Importance Compounding injectable anticancer treatments is a high-risk process, especially under high workloads. Our centralised pharmaceutical preparation unit produces around 70,000 preparations annually. Before 2025, process-related failure (PRF) reporting was underused due to the reporting form being perceived as too long and time-consuming, as well as a lack of feedback. The reporting system was redesigned, integrating a shorter reporting form and regular feedback to improve the detection of compounding failures and enhance preparation quality and safety.

Materials and Methods Preparation occurs under a vertical laminar flow hood and includes preparation sheet creation, material gathering (one tray per preparation), pharmaceutical validation and release. Final checks vary by drug: video monitoring (44%), analytical control (37%) or double visual verification (19%). A structured PRF reporting system was implemented in January 2025. A standardised classification, developed jointly by pharmacists and technicians, supported data analysis. Monthly multidisciplinary meetings reviewed frequent and serious incidents to promote reporting and continuous quality improvement.

Results Between January 2025 and January 2026, 382 incidents were reported. Reporting increased from <10 PRFs/month before June 2025 to >50/month by year-end. The main categories were workflow organisational issues (22%, n=84), preparation errors (13%, n=50) and storage-related errors (13%, n=50). Other incidents included inappropriate final control selection (9%, n=35), errors before hood entry (7%, n=25), storage at incorrect temperature (5%, n=21), or preparation sheet errors due to incorrect packaging configuration in the hospital information system (6%, n=23). Workflow issues reflected communication failures and deviations from procedures, affecting quality of work life without compromising the compliance of finished preparations intended for administration. Among preparation errors, 44% (n=22) were volume inaccuracies; others involved incorrect medical devices (22%, n=11) or solvent selection (22%, n=11). A direct cost of €10,600 was estimated for 26 remade preparations.

Conclusion and Relevance Measures to improve workflow and quality of work life are ongoing. A storage audit in early 2026 ensured compliance. A software alert was implemented to prevent configuration errors. A severity assessment tool is in development to prioritise high-risk incidents. The only patient impact was a dispensing delay due to remanufacturing. Regular feedback and staff empowerment are key to improvement.

Background and Importance Actions to protect the environment play a crucial role in reducing pollution and promoting a more sustainable future for healthcare systems. In routine clinical settings, hazardous waste management is a critical component of oncology pharmacy practice, impacting staff safety, environmental sustainability, and healthcare costs. Overclassification of waste as cytotoxic is frequently observed, often driven by uncertainty, time pressure, and unclear guidance, reflecting key human factors in decision-making.

Materials and Methods A prospective before–after study was conducted in oncology pharmacy performing approximately 30 chemo- preparations daily within a centralized compounding unit. Baseline data were collected over 6 months, including hazardous waste volume, segregation accuracy, and staff practices. A 6-month intervention followed, based on a strategy addressing human factors: in-shift training, simplified color-coded bins, visual decision aids at wards, and streamlined one-page SOPs. Key performance indicators included hazardous waste volume (kg/month), segregation accuracy (%), and estimated management cost.

Results Hazardous waste volume decreased from approximately 95–110 kg/month at baseline to 70–85 kg/month post-intervention (−20–25%). Segregation accuracy improved from 60–65% to approximately 85–90%. Staff-reported uncertainty regarding waste disposal decreased, with improved confidence in correct segregation decisions. Estimated waste management costs were reduced by 10–15% annually.

Conclusion and Relevance Cytotoxic waste overclassification is a behavior-driven, modifiable issue even in medium- throughput oncology pharmacy settings (~30 preparations/day). A structured, low-cost, high- impact intervention addressing human factors can significantly improve waste segregation accuracy, reduce hazardous waste volume, and lower costs without compromising safety.

Background and Importance Imaging procedures in oncology are essential for diagnosis, follow-up and staging. In onco- paediatrics, imaging can be hard to perform due to children's lack of cooperation. To avoid this, we developed an intra-rectal acquous preparation of pentobarbital (PBIR) for the conscious sedation of children undergoing imaging procedures. We opted to implement a “dose banding” system allowing to compound predefined standard doses (SD) with fixed dosages ensuring efficacy and safety. The aims of this study was investigate the technical feasibility and the practical modalities to implement SD of PIBR.

Materials and Methods A literature review was done to assess dosages of phenobarbital usually used for children's conscious sedation. Once these data defined, various scenarios and different possible SD configurations were proposed: two SD levels were then selected and used to establish an algorithm correlating SD to children's weight ranges. Once this algorithm validated with paediatricians, control DS batches were manufactured. Stability studies were conducted over 90 days under three storage conditions: room temperature (RT), +2°-8°C, or -20°C. Content tests were performed monthly by LC-MS/MS (n=3/sample).

Results The PBIR dosages found in the literature for paediatric conscious sedation for imaging ranged from 3 to 6 mg/kg, capped at 100mg maximal dose. Therfore, two DS were selected for our study: pre-filled syringes dosed at 20 mg and 50 mg, allowing five combinations of DS to cover the needs of children weighing from 4 to 25kg with administered dosages ranging from 20 mg to 100 mg. The control batches were produced from a PB (Fagron®) stock solution (SS) prepared in saline and dosed at 10 mg/mL. The SS was then distributed into polypropylene syringes (BD Palstipack) filled with 2mL and 5mL with tips adapted to rectal cannulas. The stability study showed that batches were stable for at least 90 days when stored at -80°C or +2°C/+8°C, with contents of 103.8%±7.8% and 99.4%±5.0% respectively, compared to 88.4%±9.9% at room temperature.

Conclusion and Relevance Our study enabled the implementation of standard doses of PBIR for onco-paediatric imaging. It enhaces the hospital pharmacy's reactivity to the onco-paediatrics department requests and improves the quality of imaging procedure. The next step will now be to evaluate feedback from healthcare professionals on the effectiveness and iatrogenicity of the newly implemented procedure.

Background and Importance Increasing evidence has demonstrated the indispensable functions of cancer-associated stroma in malignant phenotypes. The crosstalk between cancer and its surrounding stroma depends on the biological paracrine signaling mediated by distinct ECM-derived cues. The ECM parameters including mechanical properties and micro/nano-scale architectures play crucial roles in the overall behavior of tumor organoids. However, the synergistic functions of the stromal biological component and ECM physical properties on phenotypes of cancer organoids have not been widely studied.

Materials and Methods This study was designed to establish in vitro 3D breast cancer organoid models in the recreating tumor-stroma niche. We hypothesized herein that the cryogels of alginate with appropriate pore size could be a matrix-bound EGF. The matrix-bound status of EGF was analyzed by FT-IR spectrometer and its release kinetics was quantified by ELISA. The malignant phenotypes of breast cancer were evaluated by changes in cell behaviors and drug responses.The transcriptomics and metabolomics were to reveal the underlying mechanisms of cell-stroma interactions on breast cancer progression.

Results We first evaluated EGF loading and releasing properties in the alginate cryogel. A controlled release of EGF was observed at the first 3 days. The matrix-bound EGF in the biomimetic ECM induced malignant phenotypes of breast cancer organoids in proliferation, migration, EMT and apoptosis. Especially in drug resistance, a MDR effect was observed in the comparison of EGF(+) with EGF(-). The most impressive acquired resistance occurred in PTX, in accordance with clinical evidence.By RNA sequencing, the expression profile revealed that matrix-bound EGF mainly functioned on cytokine-cytokine receptor interaction and ECM-receptor interaction, then activated PI3K-AKT pathways to express signaling molecules p-STAT, p-ERK1/2, p85, and ERK5 at higher levels, and further stimulated several tumor-promoting cytokines l, meanwhile promoted gene expression of ECM components such as FN1 and metabolic enzymes such as GOT2, finally reprogrammed breast cancer energy metabolism L-Aspartic acid.

Conclusion and Relevance This study was designed to mimic the porous ECM and present EGF in a matrix-bound state with a controlled release. The matrix-bound EGF in the ECM induced malignant phenotypes of breast cancer organoids. Mechanism study revealed key pathways finally to reprogram energy metabolism. This in vitro 3D organoids in a biomimetic ECM would be a competitive model to develop novel therapeutic strategies.

Background and Importance Platinum drugs remain central in oncology but are limited by toxicity and resistance. Platinum(IV) prodrugs offer improved selectivity through intracellular reduction to active Pt(II). Axial ligand modification enables tuning of lipophilicity, uptake, and biological behavior. Here, we designed two pyrenebutyrate-conjugated Pt(IV) complexes (mono- and bis-substituted) to examine how ligand architecture influences cytotoxicity, selectivity, uptake, and mechanism in sensitive and resistant cancer models.

Materials and Methods Two pyrenebutyrate Pt(IV) complexes were synthesized from a cisplatin precursor and characterized by NMR spectroscopy. Reduction behavior was studied using biological reductants. Cytotoxicity was evaluated in ten cancer cell lines, including resistant leukemia, and in non-malignant kidney cells. IC₅₀ values were calculated from viability assays. Platinum uptake was quantified after treatment. Apoptosis-related protein changes were analyzed in leukemia cells at equi-effective concentrations.

Results The two pyrenebutyrate Pt(IV) complexes showed distinct cytotoxic profiles, emphasizing the role of axial ligand substitution. The monosubstituted derivative exhibited strong activity, with IC₅₀ values of ~50–70 nM in leukemia cells, including a cisplatin-resistant line, surpassing cisplatin. The bis-substituted complex was largely inactive in adherent tumors and non- malignant cells but retained activity in resistant leukemia, indicating structure-driven selectivity. Higher intracellular platinum levels correlated with the greater potency of the monosubstituted compound. NMR confirmed redox activation consistent with Pt(IV) prodrug behavior. Proteome profiling showed apoptosis pathway activation with distinct patterns. Although limited to in vitro data, the results support rational axial ligand design and further in vivo evaluation.

Conclusion and Relevance Pyrenebutyrate axial modification significantly altered Pt(IV) activity and selectivity. The monosubstituted complex displayed potent, resistance-overcoming effects linked to enhanced uptake. Structural design strongly influences biological behavior. These findings support rational ligand engineering of Pt(IV) prodrugs and warrant further in vivo and pharmacokinetic evaluation.

Background and Importance Platinum(II) drugs such as cisplatin are widely used but limited by toxicity, poor selectivity, and resistance driven by altered uptake, detoxification, DNA repair, and apoptosis evasion. Platinum(IV) complexes are more inert octahedral prodrugs that can be intracellularly reduced to active Pt(II), potentially enabling tumor-selective activation. Axial ligand modification also allows tuning of pharmacological properties. However, comparative mechanistic data versus cisplatin remain limited. The main objective of this study was to evaluate the in vitro efficacy and apoptosis-related mechanisms.

Materials and Methods Cytotoxicity was assessed after 72 h exposure in leukemia (BV-173, HL-60) and solid tumor (CASKI, MDA-MB-231, MCF-7, HT-29) cell lines. IC₅₀ values were determined from metabolic assays. Mechanistic studies in BV-173 cells included apoptosis-focused proteome profiling (cleaved caspase-3, p53, Fas, FADD) and AO/AO-PI fluorescence microscopy.

Results The platinum(IV) complexes showed strong cytotoxicity across all tested cancer cell lines, with IC₅₀ values mainly in the low micromolar and, for selected compounds, nanomolar range. Leukemia cells (BV-173, HL-60) were more sensitive than solid tumors. Complexes 1 and 2 outperformed cisplatin. In BV-173 cells, treatment markedly increased cleaved caspase-3 and p53 levels, indicating activation of intrinsic apoptosis. Elevated Fas and FADD supported additional engagement of the extrinsic pathway. Fluorescence microscopy confirmed typical apoptotic morphology. Although limited to in vitro data, the results indicate enhanced dual apoptosis activation compared to cisplatin and support further preclinical evaluation.

Conclusion and Relevance The Pt(IV) complexes demonstrate potent in vitro activity and stronger dual apoptosis activation than cisplatin, particularly in leukemia cells. Further in vivo and pharmacokinetic studies are required to confirm translational potential.

Background and Importance Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are major toxicities of CD19-directed CAR-T therapy. Immunomodulatory strategies vary across indications. Oncology pharmacists play a central role in toxicity grading, dosing optimization and supportive care coordination. This study evaluates diagnosis-specific immunomodulator utilization in a regional CAR-T program in the UAE.

Materials and Methods A retrospective review of 23 CAR-T infusions (Dec 2023–May 2025) at Yas Clinic Khalifa City, UAE, was conducted. Patients included ALL, B-cell lymphoma and SLE treated with ADSCC-manufactured CD19 CAR-T. CRS and ICANS were graded using 2018 ASTCT criteria. Frequency and dosing of tocilizumab, dexamethasone and anakinra were analyzed by diagnosis. Institutional approval was obtained.

Results CRS occurred in 19/23 infusions (82.6%), predominantly grade 1–2; no ICANS cases were observed. Tocilizumab was required in 100% of SLE and 88.9% of ALL infusions versus 41.7% in lymphoma. Anakinra was used exclusively in higher-grade CRS among ALL patients. Corticosteroid use was limited and diagnosis-dependent. ALL demonstrated the highest immunomodulatory burden. These findings highlight variability in inflammatory profiles across indications and reinforce the pharmacist’s role in early recognition, grading accuracy and timely biologic intervention to optimize CAR-T outcomes.

Conclusion and Relevance This first UAE real-world CAR-T analysis demonstrates diagnosis-specific differences in CRS management needs. ALL required more intensive immunomodulatory therapy compared to lymphoma and SLE. Individualized toxicity mitigation strategies and active oncology pharmacist involvement are essential in emerging CAR-T programs.

Background and Importance Interprofessional collaboration is an essential part of counseling cancer patients, but there is a lack of understanding the competencies and priorities of different health care professionals. Communication is mostly a challenge among healthcare professionals. Therefore DGOP (Deutsche Gesellschaft für Onkologische Pharmazie) introduced an educational program involving different healthcare experts. This training format combines webinars, held by various health care professionals as well as workshops to discuss different patient cases within a “tandem“ of a pharmacist and a doctor.

Materials and Methods In 2024 the DGOP introduced short webinars (30 min) with various topics to demonstrate the different competencies of healthcare professionals involved in care of patients with cancer. As second part of this program a workshop was added to the program with “tandems” of a pharmacist and a doctor. Each of these "tandems” was presenting three to four patient cases which had been discussed in small groups for 80 min. The participants rotated through all groups and at the end of the day every participant had discussed all patient cases. Tutors and participants were asked for an evaluation..

Results Up to now eight webinars had been held by pharmacists, doctors, nurses, dietitians and radiation therapists with various topics. The average number of participants was 160 (range 104- 223). After facing initial challenges in 2024 having only 10 participants, the workshop was fully booked in 2025 with 18 participants, each of them joining three groups with different topics. The topics covered tumor types with solid tumors and hematologic malignancies. In addition to pharmacists and doctors as tutors, nurses, a dietitian and a psycho-oncologist were involved. The evaluation taken from tutors and participants included remarks such as “Although the participants prior knowledge and background varied considerably, the groups were highly motivated to discuss the cases, take a very active role in shaping the training session themselves, and make the most of the time available.” One of the challenges is the tutors cost, as this format with a 2:1 participant-to-tutor ratio is personnel-intensive.

Conclusion and Relevance The program will be continued with seven webinars and one workshop per year. 2026 we will encourage young doctors to participate to enhance interprofessional exchange. By discussing patient cases the participants should gain an understanding of the expertise and approach of the ‘other’ professional group, breaking down barriers to interprofessional collaboration, which might improve patient care.

Background and Importance Febrile neutropenia and multidrug-resistant infections cause significant morbidity in immunocompromised cancer patients receiving cytotoxic chemotherapy. WHO-priority pathogens, including Acinetobacter baumannii, MRSA, and VRE, are frequently implicated. β- Thujaplicin is a natural troponoid with antimicrobial and antioxidant properties, but its use is limited by poor aqueous solubility and chemical instability. Nanocarriers may overcome these limitations. This study evaluated the antimicrobial and antioxidant efficacy of β-thujaplicin nanoformulations against clinically important pathogens.

Materials and Methods Liposomes (LS) were prepared through ethanol injection, whereas nanoemulsions (NE) were prepared using high-pressure homogenization. Both drug carriers were loaded with β- thujaplicin. Size, PDI, and zeta potential values were determined using a Malvern Zetasizer, while the EE% value was determined using a UV-Vis spectrophotometer. MIC, MBC, and MFC were obtained for both LS and NE using the broth microdilution method against bacterial and fungal strains: A. baumannii, S. enteritidis, E. coli, S. aureus, S. haemolyticus, E. faecium, C. albicans. Antioxidant activity was assessed by DPPH assay.

Results LS and NE had an average particle size of 85 nm, PDI <0.20, and zeta potential of −41 mV. Encapsulation efficiencies were above 80%. Encapsulated forms demonstrated lower MIC and MBC values than the free drug, with the greatest difference observed against S. enteritidis, where both MIC and MBC of the nanoformulations were reduced by 50% relative to free β- thujaplicin. This is directly relevant to the Gram-negative bacteremia common in febrile neutropenia. DPPH inhibition reached up to 38% for β-thujaplicin-LS. Combining antimicrobial and antioxidant activity in a single nanoformulation addresses two concurrent issues arising in oncology supportive care, simultaneously targeting opportunistic drug-resistant pathogens and oxidative stress associated with both infection and chemotherapy. These results can serve as justification for further investigations into troponoid nanoparticles as supportive tools within the oncology pharmacist's domain of competence.

Conclusion and Relevance Liposomal and nanoemulsified β-thujaplicin showed in vitro antimicrobial effects towards multidrug-resistant pathogens clinically significant in the field of oncology, as well as antioxidant properties. This information supports the use of β-thujaplicin as a nanoplatform- based adjuvant approach for immunocompromised oncology patients.

Background and Importance Health Technology Assessment (HTA) provides a multidimensional evaluation of healthcare innovations, including clinical, economic, organizational and logistical aspects. The fixed-dose subcutaneous (SC) combination of pertuzumab–trastuzumab is an effective and innovative alternative to the intravenous (IV) formulation for HER2+ breast cancer, especially in the maintenance setting. This study evaluated the impact of introducing the SC formulation in a hospital with an oncology-integrated Antiblastic Drugs Unit, comparing time, costs and organizational efficiency

Materials and Methods A retrospective analysis was conducted between August 2023 and May 2025 on 17 patients with HER2+ breast cancer, for a total of 253 SC administrations. Preparation, administration, and post-infusion observation times were compared between IV and SC formulations. Mean direct cost per dose, including materials and devices, was calculated for both routes. Avoided costs related to central venous catheter (PICC) placement and maintenance, including staff time, were also estimated.

Results SC administration resulted in an average time saving of 198 minutes per cycle, corresponding to approximately 835 total hours saved across the study period. Although the direct cost per SC dose was slightly higher than IV, this increase was offset by significant indirect savings due to avoided PICC placement and maintenance, amounting to €16,048 and about 378 healthcare working hours. Integration of the ADU within the oncology ward further streamlined workflows, reduced waiting times, and improved multidisciplinary coordination. Additionally, the lower procedural burden of the SC formulation enhanced patient experience by reducing discomfort and overall time spent in the hospital setting.

Conclusion and Relevance The SC formulation of pertuzumab–trastuzumab represents a strategic option for more efficient and sustainable oncologic care. Organizational and economic benefits, combined with improved patient acceptability and simplified care pathways, support its systematic adoption. Ward-integrated ADU models align with HTA principles and represent a replicable best practice.

Background and Importance In Italy, genomic testing is reimbursed by the National Health Service with a dedicated fund to support the cost of use in Early Breast Cancer-EBC. From an HTA perspective, this centralized funding mechanism ensures equitable access and recognizes the clinical and economic value of genomic-guided treatment strategies. Genomic assays, such as Oncotype DX, support risk stratification in HR+/HER2 EBC, allowing CT-chemotherapy de-escalation in low-risk patients tested. The aim of this study is to estimate the theoretical cost savings, resulting from CT omission, in a real-world hospital setting.

Materials and Methods A retrospective analysis was conducted including patients undergoing Oncotype DX testing between 2022 and 2025, in Italian Breast Centre. The analysis was performed considered direct drug acquisition costs only. For patients receiving adjuvant CT, treatment regimens, number of cycles and administered dosages were collected. Mean drug cost per mg-milligram and cost per cycle were calculated. Due to the heterogeneity of treatment regimens, a weighted average cost per patient was calculated and subsequently applied to patients were spared CT.

Results Between 2022 and 2025, the adoption of Oncotype DX testing increased significantly, rising from 6 to 20 patients per year, paralleled by a reduction in chemotherapy administration in low-risk EBC patients tested (from 4 cases in 2022 to 14 in 2024–25). Among treated patients, regimens included cyclophosphamide + docetaxel, TC (n=13), cyclophosphamide + epirubicin, EC (n=1), and EC followed by paclitaxel (n=5). Since it was not possible to retrospectively assign a specific regimen to untreated patients, a weighted average cost based on the real distribution of observed regimens was applied. The overall estimated theoretical cost savings amounted to €11850,88€, highlighting an increasing economic advantage associated with the adoption of the test.

Conclusion and Relevance Implementation of genomic assay was associated with chemotherapy de-escalation (with concrete clinical benefits: reduced toxicity, improved quality of life, greater psychological and physical well-being for patients) and measurable short-term drug cost avoidance. Future HTA analyses incorporating long-term outcomes are important to provide a comprehensive assessment of cost-effectiveness.

Background and Importance Ensuring the widespread availability and accessibility of anticancer medications is crucial. This aligns with the World Health Organisation's recommendation to achieve a coverage of over 80%. This study aimed to analyse anticancer procurement data to identify utilisation patterns and expenditures, aiding future planning and investment in oncology pharmacy services. The findings can enhance resource allocation, ensuring better availability and accessibility for patient care.

Materials and Methods The study examined procurement, prescribing, and dispensing records at Benjamin Mkapa Hospital (BMH). ABC analysis classified anticancers into three categories: A, B, and C. Category A includes the top 10-20% of items consuming 75-80% of the budget. Category B has an intermediate usage (10-20%) and accounts for 15-20% of expenditure. Category C, the majority with low individual usage, makes up 5-10% of the budget.

Results The expenses linked to anticancer medications have markedly escalated, experiencing successive increases of 5.74%, 16.12%, 24.10%, and 17.73% in 2020, 2021, 2022, and 2023, respectively. Notably, Bevacizumab, Rituximab, Trastuzumab, Docetaxel, Paclitaxel and Goserelin (3.6 mcg) were the most frequently utilised anticancer medications, accounting for over 64% of total drug dispensation from 2020 to 2023. Concurrently, the availability of essential anticancer treatments significantly improved, rising from 54% in 2020 to 84% in 2022 and 2023. Over the four-year period (2020-2023), anticancer drugs comprised a mere 2.8% (580 out of 20,542) of all prescriptions, predominantly for patients aged 46 and above, with 85% covered by health insurance. Breast, prostate, and stomach cancers stood out as the most prevalent, representing over 40%, 30%, and 5% of all reported cases, respectively.

Conclusion and Relevance The most common anticancer drugs include platinum, antimetabolites, alkylating agents, and taxane analogues. The most expensive are Bevacizumab, Rituximab, Trastuzumab, Goserelin 3.6mcg, and Docetaxel. BMH's oncology pharmacy increased drug availability from 54% to 84%, within WHO guidelines. Regular use and expenditure analysis are crucial for efficient inventory management in Oncology pharmacy.

Background and Importance Improving equitable access to oncology medicines remains a major challenge in low- and middle-income countries where out-of-pocket expenditure predominates. Since 2019, Senegal has implemented a national policy funding anticancer medicines for women with breast cancer. However, affordability of cancer pharmacotherapy extends beyond chemotherapy agents alone. From an oncology pharmacy perspective, assessing residual medication costs and supply- related barriers is essential to determine whether financial protection is comprehensive. This study applied the World Health Organization/Health Action

Materials and Methods A multicentre cross-sectional observational study was conducted among 99 women receiving systemic treatment for breast cancer at two tertiary hospitals in Dakar. Data were collected through structured interviews and medical record review. Monthly household income was recorded using predefined categories (<150,000; 150,000–300,000; 300,000–450,000; >450,000 FCFA). Direct medication costs were categorized as: (1) government-funded anticancer medicines, (2) out-of-pocket supportive and adjuvant medicines, and (3) additional expenses due to anticancer medicine stock-outs. Affordability was calcula

Results Most patients (69%) reported monthly household income <150,000 FCFA, and 47% had discontinued professional activity due to illness, indicating substantial financial vulnerability. The mean cost of government-funded anticancer medicines was 43,094.86 FCFA per cycle. However, 24% of patients experienced anticancer medicine stock-outs requiring private procurement, generating an additional mean out-of-pocket cost of 45,921.96 FCFA per session (≈21.4 days’ wages). Supportive and adjuvant medicines resulted in a mean monthly out-of- pocket expenditure of 14,805.27 FCFA (≈6.9 days’ wages). Under WHO/HAI affordability standards, supportive medication costs alone represent nearly one week of wages, indicating limited affordability despite chemotherapy coverage. Stock-outs further increased financial burden and risk of treatment interruption. From an oncology pharmacy standpoint, these findings highlight deficiencies in supply chain reliability and incomplete financial coverage of essential sup

Conclusion and Relevance Although government funding of anticancer medicines improves access, breast cancer pharmacotherapy remains insufficiently affordable under WHO/HAI criteria. Strengthening pharmaceutical supply systems and expanding reimbursement to essential supportive

medicines are critical to improving financial protection and treatment continuity. These findings are applicable to similar resource-limited hospit

Background and Importance Pembrolizumab (Pb) is an immunotherapy whose expanding indications have led to a substantial increase in its use in oncology. Initially administered based on weight, non-inferiority studies later validated fixed doses (fd) of 200 mg and 400 mg with comparable efficacy and safety. Supported by stability data, these regimens allow anticipatory infusion bag preparation and improve day-hospital organization. However, the high cost places a growing burden on national health insurance and hospital cash flow, prompting reassessment of weight-based dosing while considering organizational impact.

Materials and Methods We conducted a single-centre retrospective pharmacoeconomic study including all patients who received a Pb containing regimen during 2025. Data were extracted from Chimio® and validated against hospital billing data (French discharge database). For each patient, a simulated dose based on weight was calculated and compared to the fd actually administered.The associated costs were estimated in order to assess the potential savings. Finally, with a view to striking a balance between economic efficiency and organisational constraints, different dose standardisation strategies were evaluated.

Results 64 patients received a total of 476 Pb cycles in 2025. Among them, 58 patients received 200 mg every 3 weeks (Q3W) (440 cycles ; mean weight μ=69.4 kg, median m=67 kg [41–126]), resulting in a mean theoretical weight-based dose (μtd) of 139 mg, 30% lower than the fd. 6 patients received 400 mg every 6 weeks (Q6W) (36 cycles ; μ=83.7 kg, m=78.5 kg [60–118]), with a μtd of 335 mg, 16% lower. For patients >100 kg, the weight-based dose was capped at the standard fd (200 mg Q3W or 400 mg Q6W). Total actual cost was €2,244,588, while strict weight-based dosing would have cost €1,545,469, yielding potential annual savings of €699,119 (~319 vials). Intermediate strategies using multiple standardized doses based on quartiles (125, 150, 175, 200 mg) or two fd (140 and 200 mg) could save €448,808 and €343,264, respectively. In the absence of a sufficient cohort, it is difficult to predict new QW6 standards at this time. Weight- based dosing remains the preferred method for our institution.

Conclusion and Relevance Weight-adjusted pembrolizumab dosing could generate substantial savings without reducing efficacy shown by non-inferiority studies. In the absence of individualised pharmacokinetic data, institutions can help control costs. These findings may apply to other expensive immunotherapies, warranting the establishment of multicentre studies and working groups focused on its implementation.

Background and Importance Advanced renal cell carcinoma treatment has been revolutionized by immune checkpoint inhibitor and tyrosine kinase inhibitor combinations. However, these high-cost therapies represent a significant burden for National Health Service budgets, highlighting the need for real- world evidence to support both clinical choices and resource allocation. This study evaluates the safety, clinical efficacy, and economic sustainability of Pembrolizumab plus Lenvatinib versus Nivolumab plus Cabozantinib as first-line treatments within the daily clinical practice of an Italian Local Health Unit.

Materials and Methods An observational, retrospective, single-center study was conducted on consecutive patients with advanced renal cell carcinoma treated between February 2023 and June 2025. Progression- free survival (PFS) was estimated using the Kaplan-Meier method. Economic analysis focused on annual direct costs per patient, calculated using ex-factory prices and regional fees for drug preparation and administration. Safety was assessed through adverse events recorded in clinical databases, electronic records, and national registries.

Results Twenty-four patients were analyzed (N=10 Nivolumab + Cabozantinib; N=14 Pembrolizumab + Lenvatinib) with a median follow-up of 6.8 months. Nivolumab + Cabozantinib showed a 12- month PFS probability of 80% versus 62% for Pembrolizumab + Lenvatinib (p=0.45), with no statistically significant difference observed in clinical efficacy between the two regimens in a real-world setting. Treatment-related adverse events occurred more frequently in the Pembrolizumab + Lenvatinib group (36% vs 10%). From an economic perspective, Nivolumab + Cabozantinib was associated with a lower annual direct cost per patient (€155,000) compared to Pembrolizumab + Lenvatinib (€160,000), resulting in an average saving of €5,000 per patient. This difference is mainly due to the lower unit cost of Nivolumab. Despite the small sample size, these findings suggest that Nivolumab + Cabozantinib offers a more favorable economic and safety profile for the National Health Service.

Conclusion and Relevance Both regimens show comparable effectiveness in real-world practice. However, Nivolumab plus Cabozantinib appears more sustainable for the National Health Service due to its favorable safety profile and lower direct costs. These results highlight the value of pharmacoeconomic evaluations in hospital pharmacy. Further studies are needed to confirm these findings over a longer follow-up period.

Background and Importance Lutetium vipivotide tetraxetan (177Lu-PSMA) is a radiopharmaceutical combining lutetium-177 with a ligand targeting prostate-specific membrane antigen (PSMA), indicated for adults with progressive PSMA-positive metastatic castration-resistant prostate cancer. Although commercially available in Portugal since 2022, access remains complex and restricted as it is undergoing the public reimbursement process. Treatment is provided only through an Early Access Program (EAP), requiring specialized infrastructure for handling, administration, and inpatient care.

Materials and Methods Analysis of the 177Lu-PSMA clinical pathway in a Portuguese Local Health Unit (Group D) without a Nuclear Medicine Department (NMD).

Results Inclusion in the EAP requires case-by-case authorization by INFARMED, the Portuguese medicines regulatory authority, and approval by local hospital committees. Since May 2024, 12 requests for 177Lu-PSMA have been submitted. Care is coordinated between the referring hospital, responsible for the request and funding, and a hospital with a NMD, which evaluates, authorizes, and administers the radiopharmaceutical. Only 6 patients initiated therapy, with a mean interval of 82 days between request and first administration. In hospitals without NMD, access depends on external institutional availability and responsiveness, resulting in prolonged referral times. These delays are often incompatible with oncologic disease progression and may compromise treatment efficacy due to clinical deterioration. Delayed initiation was associated with clinical worsening and unfavorable outcomes, including mortality, largely reflecting the limited capacity and geographic concentration of NMD-equipped centers.

Conclusion and Relevance Despite marketing authorization, access to 177Lu-PSMA in Portugal remains limited by administrative complexity, high costs, and regulatory constraints. Its use is restricted to institutions with NMD, requiring referral from hospitals without this capacity, making treatment initiation dependent on external availability and leading to significant delays that may compromise oncologic outcomes.

Background and Importance ERBB2 (HER2) mutations occur in 2–4% of NSCLC. No targeted therapies are reimbursed by the Italian Medicines Agency for this population, making early access programs essential. Therapeutic continuity relies on two regulatory frameworks: Law 94/1998 (off-label use) and D.M. 7/09/2017 (compassionate use, including Named Patient Programs, NPP, and Early Access Programs, EAP). Objective: Describe the sequential management of a HER2-mutated NSCLC patient and quantify the pharmacoeconomic impact of transitioning between access pathways through oncologist-pharmacist multidisciplinary collaboration.

Materials and Methods Single-patient retrospective case report. Clinical and pharmacological data were collected from medical records. Three sequential treatment lines were administered through distinct access pathways. Pharmacoeconomic evaluation of trastuzumab deruxtecan [T-DXd](Enhertu®) was based on the AIFA ex-factory price (€2,332.56/100 mg vial), calculating institutional expenditure under Law 94/1998 and potential savings achievable through early NPP activation under D.M. 7/09/2017.

Results A 41-year-old non-smoking woman with stage IV lung adenocarcinoma harbouring an ERBB2 exon 20 insertion mutation received three sequential treatment lines. First-line carboplatin + pemetrexed + cemiplimab (Libtayo®) under standard AIFA reimbursement resulted in progressive disease after 3 cycles. T-DXd was then initiated off-label (Law 94/1998), achieving partial response over 12 cycles, later transitioned to NPP. Under Law 94/1998, costs are borne by the local institution; under D.M. 7/09/2017 NPP, by the manufacturer. Nine off-label cycles cost €62,979.12 to the institution; NPP transition saved €20,992.68. Early NPP activation from cycle 1 would have avoided €83,973.36. Following progression, proactive pharmacist-oncologist collaboration enabled rapid NPP activation for sevabertinib — not commercially available in Italy and still in clinical trials — provided free of charge within only 2 weeks. Limitation: single-patient report; generalisability constrained by population rarity.

Conclusion and Relevance In ultra-rare oncological indications, therapeutic continuity is only achievable through sequential use of available access pathways. The hospital pharmacist plays a pivotal role in their timely activation, with measurable impact on patient outcomes and institutional costs. This model is replicable in any oncology centre managing patients with rare molecular drivers and unmet needs.

Background and Importance Early access programs (EAP) and Named Patient Programs (NPP) are two distinct compassionate use pathways regulated in Italy under D.M. 7/09/2017, enabling oncology patients to receive innovative therapies prior to national reimbursement. The hospital pharmacist plays a central role throughout the entire lifecycle of these programs, yet the economic and clinical value generated is rarely quantified at institutional level. Objective: describe the hospital pharmacist's role in managing EAPs and NPPs and estimate the economic value of free drug supply obtained for the local healthcare institution.

Materials and Methods Retrospective descriptive analysis of all EAPs and NPPs managed by the Hospital Pharmacy Unit in collaboration with the Medical Oncology Units of the San Jacopo (Pistoia) and SS. Cosma e Damiano (Pescia) Hospitals, Italy, in 2025. Data collected included the number of programs, drugs, oncological indications, patients enrolled and treated, and quantities supplied free. The economic value was calculated using official AIFA ex-factory prices. Two programs (sevabertinib and repotrectinib), lacking official pricing, were excluded from the economic analysis but included in the descriptive overview.

Results In 2025, 11 EAP/NPP programs were active across 10 oncological indications (breast, lung, urothelial, gastric and endometrial cancers), involving 22 patients treated. Economic analysis was restricted to 9 programs involving 20 patients, coordinated by the hospital pharmacist, with confirmed AIFA ex-factory pricing: trastuzumab deruxtecan, durvalumab (3 indications), pembrolizumab + enfortumab vedotin, ribociclib, amivantamab, dostarlimab and zolbetuximab. Total institutional savings amounted to ~€761,728. Ribociclib was the largest contributor (€268,721), reflecting the high local prevalence of HR+/HER2- early breast cancer. Sevabertinib and repotrectinib, lacking official Italian pricing, were excluded from the economic analysis but represent additional clinical value. EAPs/NPPs provided patients access to therapies 12–24 months before expected national reimbursement. Limitation: savings reflect gross ex-factory values; actual savings may differ based on negotiated discounts.

Conclusion and Relevance A proactively managed EAP/NPP portfolio, coordinated by the hospital pharmacist, generates substantial and measurable economic value — nearly €762,000 in free drug supply from certified programs alone — while expanding patient access to innovative oncology treatments,

otherwise unavailable, ahead of formal reimbursement. This model is replicable across oncology centres.

Background and Importance Subcutaneous (SC) formulations of monoclonal antibodies allow faster and less invasive administration than intravenous (IV) routes, with comparable efficacy and safety. Beyond clinical equivalence, SC administration may reduce hospital resource use, improve patient experience, and increase treatment capacity, contributing to the sustainability of oncology care. This study aimed to develop and apply a hospital-based, multidisciplinary model to assess the economic and organisational impact of IV-to-SC transitions in oncology

Materials and Methods A hospital-based HTA evaluated the budget impact and organisational capacity of transitioning from IV to SC monoclonal antibodies in oncology using real-world data from a high-volume oncology centre collected before price renegotiations. The analysis included drug acquisition, pharmacy preparation, nursing administration, chair occupancy, and staff time, with preparation costs estimated through Time-Driven Activity-Based Costing. The model was applied to two monoclonal antibodies, identifying eligible patients from institutional registries and simulating partial and full IV-to-SC substitution.

Results The analysis showed that transitioning oncology monoclonal antibodies from IV to SC administration can significantly reduce organisational burden while keeping overall budget effects limited. Using real-world data from a high-volume cancer centre, the analysis included drug acquisition, pharmacy preparation, nursing time, chair occupancy, and staff workload, with TDABC used to estimate preparation costs. For mAb X, full SC transition increased treatment capacity by ~36%, with €123.354,00 in additional drug expenditure and an overall budget impact of €66.778,00. For mAb Y, full SC adoption raised capacity by ~19%, requiring €42.473,00 in added drug spending and a total budget impact of €6.671,00. Scenario simulations showed that SC substitution consistently reduced preparation and administration time, freeing clinical resources and improving throughput. Overall, adopting the SC route enabled better use of clinical time and expanded care opportunities while keeping the budget impact low.

Conclusion and Relevance SC-related efficiency gains are highly context dependent and are maximized in settings with latent capacity demand. The proposed hospital-based HTA framework supports evidence-based adoption strategies and informs sustainable pricing and organisational decision-making in oncology.

Background and Importance Targeted therapies, also known as molecularly targeted therapies, are innovative pharmacological treatments that specifically act on cancer cells. However, access to these therapies is not always guaranteed. In Tunisia, the "ACCESS Program" is a tripartite agreement between the PCT (Central Pharmacy of Tunisia), the DPM (Directorate of Pharmacy and Medicines), and donor laboratories, designed to provide these treatments to indigent patients. This study aims to describe the access to treatment via the ACCESS Program for indigent patients managed at the Salah Azaiez Institute.

Materials and Methods This is a retrospective descriptive study reviewing the status of ACCESS Program targeted therapies available at the Salah Azaiez Institute during the year 2024. It describes their provision and identifies the challenges surrounding these treatments.

Results A total of 728 patients were included in the study. 605 patients (83.1%) received injectable treatments, while 123 patients (16.89%) received oral therapies. The injectable targeted therapies used at our institute included: Trastuzumab, Bevacizumab, Pertuzumab, and Rituximab. The oral targeted therapies dispensed were: Sunitinib, Ribociclib, Abiraterone, Palbociclib, and Pazopanib. Most patients (35.17%) received Trastuzumab, followed by Bevacizumab (22.90%) and Rituximab (13.24%). The availability of these treatments was inconsistent, with frequent stockouts noted. This issue directly impacts patient management (treatment delays, interruptions), potentially leading to complications, relapses, or disease progression. Healthcare professionals are also affected, as they must manage the psychological distress of patients and their families, who experience heightened anxiety due to the uncertainty of treatment availability.

Conclusion and Relevance Targeted therapies represent an innovative alternative in cancer treatment; however, disrupted availability calls their therapeutic benefits into question. A revision of the pricing for these treatments could serve as a corrective solution to address these availability issues.