Journal of Oncology Pharmacy Practice最新文献

BackgroundRibociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor used in metastatic breast cancer, is a time-dependent inhibitor of cytochrome P450 (CYP) 3A4. While interactions with direct oral anticoagulants (DOACs) are recognized, interactions with warfarin may be underrecognized.Case PresentationA woman in her late 70's taking warfarin for atrial fibrillation developed a critically elevated international normalized ratio (INR) of 16.4 and epistaxis approximately 2 weeks after initiation of ribociclib for breast cancer. She had been transitioned from apixaban to warfarin approximately 2 months earlier due to concern for a potential interaction between apixaban and ribociclib. Her INR had remained stable prior to ribociclib initiation, with a time in therapeutic range (TTR) of 78%.Management and OutcomeThe patient required reversal with vitamin K and 4-factor prothrombin complex concentrate (4F-PCC). Ribociclib-associated CYP3A4 inhibition was considered the most plausible contributing factor to the critically elevated INR. Warfarin was resumed at a reduced dose with close outpatient monitoring.DiscussionThis case highlights the risk of a clinically significant anticoagulant interaction following ribociclib initiation. Although warfarin allows monitoring via INR, insufficient early monitoring may increase patient risk. Weekly INR monitoring during the first 2 cycles of ribociclib may improve safety.

BackgroundSystemic anticancer cytotoxic therapies (SACT) often have complications that can lead to unexpected hospital attendances usage (UHA) and protocol modifications (PM). UHA have been associated with poorer median survival and increased economic burden on healthcare systems. Our study aims to identify any significant predictors for UHAs and PMs.MethodsOur single centre retrospective cohort study aims to identify any significant predictors for UHAs and PMs. Patient demographics, details of UHA and SACT regimen data were collected for each patient between March 2024 to March 2025. For our univariate analysis of possible predictors, we used chi squared for any association between categorical variables and independent t tests for continuous variables. While for multivariate analysis, binary logistic regression was conducted to identify any significant predictors.Results534 patients were analysed with 218 (40.8%) having stage IV disease. 314 patients (58.8%) had at least one UHA and 378 patients (70.8%) had PMs. There were no significant predictors for UHAs. While patients who progressed on SACT was a predictor for PMs (HR 2.514, 95%CI 1.216-5.198, p = 0.013). Furthermore, progression on SACT (HR 0.441, 95%CI 0.232-0.841, P = 0.013) and line of therapy (HR 0.719, 95%CI 0.567-0.912, P = 0.0006) were predictors for completing all SACT cycles. Finally, age (HR 1.026, 95% CI 1.002-1.051, p = 0.036) and line of therapy (HR 0.679, 95% CI 0.530-0.870, p = 0.002) were predictors for dose reduction.DiscussionLine of therapy was a predictor for patients completing their SACT and undergoing a dose reduction. Potentially, older patients could have an upfront dose reduction to improve their quality of life. Our limitations consisted of our study being a single centre and using retrospective data collection. Future multi centre prospective studies are needed to understand the scale of the problem and validate this study results.

To review pharmacology, pharmacokinetics, therapeutic use, product safety/description and perspectives on use of lutetium Lu 177 vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). Data sources: A literature search was conducted using PubMed/Dynamed (October 2013-May 2025), limited to English language, humans, clinical trials, case reports, and guidelines. Data summary: Lutetium Lu 177 vipivotide tetraxetan is comprised of the beta-emitting radioisotope lutetium Lu-177 linked to a peptide, vipivotide tetraxetan, which binds to cells expressing prostate-specific membrane antigen (PSMA), resulting in cell death from the radiation. Kidney excretion may result in increased renal toxicity in patients with reduced renal function. Based on 2 phase III clinical trials, lutetium Lu 177 vipivotide tetraxetan 7.4 GBq administered intravenously every 6 weeks for up to 6 doses is effective in patients with mCRPC and PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor and docetaxel therapy or an androgen receptor pathway inhibitor alone, by significantly improving radiographic progression-free survival. It is generally well tolerated, with asthenia/fatigue, dry mouth, mild nausea and low-grade anemia most commonly occurring. Severe adverse drug reactions are uncommon. It should only be administered by trained personnel in a designated clinical setting with existing radiation safety protocols. Patients must limit close contact, use precautions with using the bathroom and other daily activities in days following treatment. Patient education is necessary to ensure safe daily practices. Several ongoing trials are evaluating lutetium Lu 177 vipivotide tetraxetan in combination with other anticancer agents for treatment of mCRPC, using different dosing strategies, or in other settings (metastatic castration-sensitive prostate cancer and early-stage prostate cancer). Conclusion: Lutetium Lu 177 vipivotide tetraxetan is an effective and well tolerated treatment for patients with mCRPC, PSMA-positive metastases after progressing on an androgen receptor pathway inhibitor ± docetaxel. Ongoing studies evaluating its use in earlier disease stages and with different dosing strategies, will better define the role of this therapy in the treatment of prostate cancer.

IntroductionElranatamab, a bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, has demonstrated remarkable efficacy in relapsed or refractory multiple myeloma (RRMM). With the growing clinical use of BCMA-directed bispecific antibodies, their safety profile continues to evolve; however, progressive multifocal leukoencephalopathy (PML) has not been systematically described with elranatamab to date.Case ReportA 67-year-old woman with RRMM achieved a complete response following elranatamab therapy. After the seventh treatment cycle, she developed neurological symptoms including dysarthria and gait disturbance. Brain magnetic resonance imaging revealed multifocal, non-enhancing white-matter lesions, and cerebrospinal fluid polymerase chain reaction confirmed JC virus infection, establishing the diagnosis of PML.Management and OutcomeElranatamab was discontinued immediately. Despite treatment with intravenous immunoglobulin, mirtazapine, and compassionate-use nivolumab, her neurological status progressively worsened, necessitating intubation and intensive care management.DiscussionThis case suggests a probable association between elranatamab therapy and JC virus reactivation leading to PML. The pathogenesis is likely multifactorial, reflecting both prior cumulative immunosuppression and elranatamab-induced plasma-cell depletion with resultant hypogammaglobulinemia. Clinicians should maintain vigilance for new or unexplained neurological manifestations in patients receiving BCMA-directed T-cell-redirecting therapies. Early neuroimaging and cerebrospinal fluid JC virus testing, combined with proactive immunoglobulin replacement and systematic pharmacovigilance, are essential for timely diagnosis and improved outcomes. Overall, this case highlights the need for early JC virus monitoring and awareness of delayed neuroinfectious complications associated with BCMA-targeted immunotherapies.

BackgroundAlthough syringe preparation for large-volume (>3 mL) subcutaneous (SC) drugs represents a significant workflow burden for pharmacists, their preferences for alternatives such as on-body delivery systems (OBDSs) are unexplored.ObjectiveTo evaluate pharmacists' preferences for preparing OBDSs vs. syringes.MethodsIn this cross-sectional study, pharmacists in US academic or community settings with experience preparing SC daratumumab/hyaluronidase (HYAL), rituximab/HYAL, pertuzumab/trastuzumab/HYAL, and/or efgartigimod/HYAL completed a double-blinded, 21-item, online survey that included questions about preferences regarding the preparation of prefilled syringes versus an OBDS.ResultsThirty pharmacists completed the survey. 100% responded that the OBDS appeared to be easy to prepare and easy to learn how to prepare and preferred it to syringe preparation. In response to a preparation scenario without reduced warming time that included preparation specifics, 86.67% preferred OBDS preparation to the syringe used to administer daratumumab/HYAL due to (1) time required to prepare the drug, (2) effort required to prepare the drug, and (3) optionality in drug preparation location. 29 pharmacists (96.67%) felt that the OBDS would reduce burden, 30 (100%) felt that it would improve efficiency, and 27 (90%) felt that it would reduce preparation errors. 22 pharmacists (73.33%) felt that the OBDS could provide optionality since it can be prepared outside of the pharmacy, and 100% felt that OBDS preparation would eliminate needlestick injuries.ConclusionPharmacists reported that an OBDS would be easy to prepare and to learn how to prepare and would improve pharmacy efficiency and safety compared with syringes used for large-volume SC drug administration.

IntroductionChemotherapy-induced alopecia results in a poor quality of life, compromised immune system, and adverse effects on cancer prognosis. Its prevention is vital in patients with gastrointestinal cancer; however, there are no standard guidelines for prevention. The efficacy of a scalp alpha lipoic acid derivative-containing lotion (ALADL) remains unknown. Therefore, we evaluated the effects of ALADL on chemotherapy-induced alopecia in patients with gastrointestinal cancer.MethodsThis single-center prospective cohort study included 21 patients with gastric and colorectal cancer who received chemotherapy between May 2021 and December 2023. The patients were divided into two groups: those who used ALADL and those who did not. Gross alopecia score and head hair diameter were measured immediately before initiating chemotherapy and after one and three courses.ResultsNo significant differences existed in age, sex, cancer type, chemotherapy regimen, clinical stage of TNM classification, Eastern Cooperative Oncology Group performance status, comorbidity, or medication between the two groups. After three courses of chemotherapy, a significant difference was observed between the ALADL and the non-ALADL groups, with the ALADL group showing significantly larger hair diameters (whole, pigmented, white) (p = 0.022, 0.029, 0.020). Patients who underwent one and three courses of chemotherapy and used ALADL showed a significant increase in white and pigmented hair diameters compared with that noted in patients before chemotherapy (p < 0.05). In the group that did not use ALADL, there were significantly more patients with grade 1 or higher gross alopecia after three courses of chemotherapy compared with that before chemotherapy (p < 0.05).ConclusionsIn this study, an increase in hair diameter after chemotherapy was found in the ALADL-treated group including patients with gastric or colorectal cancer undergoing chemotherapy; no significant worsening of gross alopecia grade was confirmed. However, as this was an observational study, a randomized controlled trial is warranted to verify the effects of ALADL.

IntroductionChemotherapy and monoclonal antibodies are increasingly associated with hypersensitivity reactions (HSRs), including anaphylaxis. Desensitization modulates allergic responses to drugs, facilitating temporary tolerance to full therapeutic doses.MethodsObservational, descriptive, ambispective study from August 2020 to August 2024, including cancer patients who came for treatment administration and developed a hypersensitivity reaction, and underwent 3-bag 12-step desensitization in 5.67 h. Demographic variables, atopic and oncological history, hypersensitivity reactions, breakthrough reactions (BTR) during desensitization, and safety of the protocols were reported.Results927 desensitization in 219 patients, 20.7% with personal atopy and 84% female. The most common oncological diagnoses were: breast cancer (23.3%), ovarian (22.1%), and cervical (15.9%). The drugs of the most hypersensitivity reactions were Paclitaxel 372 (40.2%), Carboplatin 172 (18.7%), Oxaliplatin 66 (7.1%), Docetaxel 59 (6.4%), Rituximab 40 (4.3%) and Trastuzumab 40 (4.3%). The most frequent hypersensitivity reactions were cutaneous 172 (18.6%), respiratory 173 (18.7%) and cardiovascular 165 (17.8%) with a severity scale of Brown I 12.1%, Brown II 43.3% and Brown III 44.6%. During desensitization 80/927 cases (8.6%) had breakthrough reactions: cutaneous 56 (6%), respiratory 18 (1.9%) and cardiovascular 17 (1.8%), of which the majority were mild reactions. All patients completed their desensitization with no deaths reported.ConclusionsOur study reports that patients undergoing desensitization protocols had a lower percentage of breakthrough reactions compared to the previous hypersensitivity reactions, showing that this procedure is safe and effective to continue first-line oncological treatment.

PurposeOsimertinib, which is a key treatment for patients with epidermal growth factor receptor gene mutation-positive non-small cell lung cancer (EGFR mt NSCLC), causes intractable adverse events for some patients. The objective of this study was to assess the impact of pharmacist consultation in a pharmacist-led outpatient clinic (PLOC) and the effectiveness of pharmacist interventions on osimertinib treatment.Patients and MethodsThis observational cohort study included patients who started osimertinib for EGFR mt NSCLC at Aichi Medical University Hospital between April 2018 and December 2021. The duration of treatment and occurrence of adverse events were compared according to whether they consulted a PLOC pharmacist, and whether they received pharmacist intervention. This study was approved by the ethical review board of the university (approval no. 2019-203).ResultsThe median duration of treatment was significantly longer for the patients who consulted with the PLOC pharmacist than for those who did not (561 vs 203 days, hazard ratio 0.40, p < 0.001). The median duration of treatment was significantly longer for patients who received pharmacist intervention than for those who did not. (774 vs 237 days, hazard ratio 0.39, p < 0.001). The discontinuation rate was significantly lower in patients who consulted a PLOC pharmacist than for those who did not (73% vs 97%, p = 0.008). However, the rates and reason for osimertinib discontinuation or dose reduction did not differ between groups.ConclusionPLOC consultation and intervention for the treatment of adverse events might have led to extending the duration of osimertinib treatment.

ObjectiveTo summarize the current status, mechanisms, challenges, and future directions of immunotherapy in advanced rectal cancer.Data SourcesPublished clinical trials, translational studies, and mechanistic reports on immunotherapeutic strategies for colorectal and rectal cancer.Data SummaryImmune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 and CTLA-4 blockade, show promise in MSI-H rectal cancer, while combination therapies are under investigation for microsatellite stable (MSS) tumors. Tumor vaccines and T-cell-based approaches, such as CAR-T and TCR-engineered therapies, are emerging strategies. Major barriers include immune evasion, microenvironment heterogeneity, and resistance mechanisms in MSS disease.ConclusionsImmunotherapy is transforming the treatment landscape of advanced rectal cancer, yet challenges persist. Continued mechanistic exploration and rational combination strategies are essential to improve response rates and expand benefit to MSS patients.