Journal of Oncology Pharmacy Practice最新文献

Background: Systemic mastocytosis (SM) is a rare and potentially severe hematologic disorder characterized by the clonal proliferation of mast cells (MCs) into various organs. The clinical manifestations of advanced SM are caused by the uncontrolled release of cytokines and vasoactive amines from MC and disease-induced organ dysfunction. Patients with SM typically present with symptoms such as flushing, pruritus, diarrhea, and headaches, but outcomes following active treatment have not been well characterized. In this study, the clinical characteristics, treatment patterns, and natural history of an SM patient cohort diagnosed and treated within a community hematology network in the United States is described.

Methods: We identified 105 patients who were diagnosed and managed in one of 19 community hematology clinics up to an index date of 1 October 2022. Data collection included patient and disease characteristics, baseline biochemistry and hematology, SM diagnostic criteria being met, biomarkers tested, CD2 and/or CD25 expression in MCs as well as serum tryptase levels at presentation. Data abstraction also included supportive care drugs and anticancer therapy used, treatment response, reason for discontinuation, and overall survival by disease subtype.

Results: A total of 105 SM patients were identified who met the inclusion criteria. The specific SM subtypes were indolent (47.6%), aggressive (9.5%), SM with an associated hematological neoplasm (19.0%), MC leukemia (1.9%), and subtype not documented (21.9%). Regardless of subtype, approximately 62% of patients did not receive SM-directed active therapy. Only 26% of patients with indolent systemic mastocytosis (ISM) received treatment compared to 65.6% with advanced subtypes. Relative to ISM cohort, the relative risk of death in patients with the advanced SM subtypes was approximately 15 times greater (hazard ratio = 15.0; 95% confidence interval: 3.3 to 66.5).

Conclusions: SM patients present with multiple underlying symptoms, within various disease subtypes that are difficult to diagnose in a timely manner. As a result, many patients do not receive active drug therapy for their disease. Therefore, greater disease awareness is required as well as new tools for earlier disease detection.

Purpose: Chemotherapies are medications with narrow therapeutic indices and potential for severe adverse events that account for at least 1 to 3% of medication errors in all adult and pediatric oncology patients. The use of an electronic chemotherapy order verification (ECOV) checklist can standardize the steps of chemotherapy verification by pharmacists, which can potentially increase medication error detection at the point of dispensing. This study evaluated the implementation of a standardized chemotherapy order verification checklist on pharmacist error reporting, particularly good-catches or near-misses type errors.

Methods: This retrospective, quasi-experimental, pre-/post-analysis of internal voluntary medication errors reported from 12 University Hospitals Seidman oncology infusion centers from June 2022 through December 2022. Error reports, categorized based on severity, were compared pre/post-implementation of the ECOV checklist.

Results: A total of 62 and 71 cases of medication errors were reported in the pre-intervention and post-intervention periods, respectively. The rate of pharmacy reported medication errors was 2.4 times greater in the post-intervention period of the ECOV checklist (p < 0.006). Pharmacy reported errors increased among all error severities reported. However, the finding did not deduce a statistically significant difference (p < 0.244).

Conclusion: This study demonstrates the effectiveness of implementing the ECOV checklist in increasing the rate of pharmacy reported medication errors. The checklist was designed to complement existing pharmacist workflow and provide a source of documentation for steps of sequential pharmacist evaluation.

Objective: Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common subtype. Abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6, was approved to reduce risk of recurrence in high-risk, HR+, HER2-, early breast cancer based on the monarchE trial. The most common adverse events reported in monarchE were diarrhea, neutropenia, and fatigue. Real-world tolerability data and incidence of adverse events with abemaciclib in the adjuvant setting versus the metastatic setting is lacking.

Data sources: This is a retrospective analysis of HR+, HER2- breast cancer patients on abemaciclib from March 2018 to September 2021 at Robert H. Lurie Comprehensive Cancer Center in Chicago, Illinois. Incidence, grade of adverse events, dose reductions, and discontinuations were evaluated in patients taking abemaciclib in the adjuvant setting and the metastatic setting.

Data summary: Of the 30 patients included in this analysis, 100% experienced an adverse event of any grade. During treatment, 12.5% treated in the adjuvant setting and 35.7% in the metastatic setting experienced grade ≥3 adverse events. Adverse events leading to discontinuation of abemaciclib occurred in 18.8% of patients in the adjuvant setting and 57.1% in the metastatic setting.

Conclusions: This data suggests abemaciclib is better tolerated in high-risk, HR+, HER2-, node-positive, early breast cancer treated in the adjuvant setting compared to the metastatic setting. Management of adverse events is crucial to help patients stay on therapy to improve clinical outcomes. Real-world tolerability of abemaciclib in both the adjuvant and metastatic settings is of importance.

Objective: To study the role of Osteoclast inhibitors in advanced prostate cancer metastasis treatment and their efficacy in reducing skeletal related events.

Methods: data source: A comprehensive search was done using search terms as "osteoclast inhibitors" "Bisphosphonates" "Zoledronic acid" " pamidronate" " Alendronate" "Denosumab" " Prostate cancer metastasis" in pubmed and Google scholar. Relevant articles were screened and collected . The collected articles were used to frame the review and data showing use of Osteoclast inhibitors In prostate cancer bone metastasis was collected.

Data summary: Prostate cancer metastasizes most commonly to the skeleton thus leading to significant morbidity ranging from pain, pathological fractures to spinal cord compression and are the primary cause of patient disability and reduced quality of life.Initially, radiation therapy and radiopharmaceuticals were the mainstay of treatment however the role of Bisphosphonates and denosumab has become an integral part of therapy to manage metastatic prostate cancer. These agents significantly decrease skeletal related events and enhance patients quality of life. Emerging therapies like Radium-223 have also shown promise in reducing skeletal related events and also improving survival rates in patients with bone metastasis. Other treatment options which are being used are systemic agents like Docetaxel, cabazitaxel, hormonal therapies like abiraterone and enzalutamide. Immunotherapy with sipuleucel-T has demonstrated a reduction in mortality among prostate cancer patients with metastasis, highlighting the need for further research in this area. Ongoing studies are investigating novel agents that target both tumor cells and the bone microenvironment.

Conclusion: Osteoclast inhibitors are effective in reducing skeletal related events in advanced bone metastasis and improve the quality of life of patients.

Objective: Despite significant advances in cancer treatment with targeted therapies and immunotherapies, cytotoxic chemotherapies are still extensively used. Potential cytotoxic contamination in preparing and administrating cytotoxics is still a major source of concern. Besides advanced protections including biological safety cabinets, work surface contamination needs to be continuously controlled to ensure that handling procedures and cleaning were appropriate. Contamination monitoring needs to be standardized.

Data sources: The study searched Pubmed/Medline and Embase with"hazardous drug", "cytotoxic drug", "surface contamination", "environmental contamination", "wipe sample", "pharmacy", "care unit", and selected studies reporting contamination results in work environment for pharmacy technicians and nurses, from 1 January 2017 to 31 December 2022.

Data summary: The 29 studies totalized 16,196 samples and 189,571 assays. Contamination results showed 39.8% sample positivity, and 8.2% assay positivity. Multicentric studies gathering at least 500 samples or up to 800 samples would limit heterogeneity in sample positivity. In addition, monitoring of an appropriate tracer selection including at least the 7 tracers with the highest contamination frequencies (cyclophosphamide, gemcitabine, fluorouracile, ifosfamide, platinum derivatives, paclitaxel and methotrexate) would facilitate contamination comparisons amongst studies and local results. Most recent studies reported thresholds for cyclophosphamide close to 0.1 ng/cm² at the 90^th percentile.

Conclusions: The overall risk of exposure for healthcare professionals is a major concern. Sample size in multicentric studies would require at least 500 samples; quantification of all tracers with the highest contamination frequencies need to be quantified. This approach would provide a basis to develop guidelines to appropriately monitor contamination in pharmacies and patient care area managers.

Introduction: Mutated rearranged during transfection (RET) kinase is found in approximately 1-2% non-small-cell lung cancer (NSCLC) patients. These patients are typically younger, non-smokers, and have non-squamous histology. Pralsetinib is a novel RET inhibitor that showed promising efficacy and tolerability in the ARROW trial. Due to the small percentage of patients that have RET mutated NSCLC, real world data on safety is still needed.

Case report: This case report outlines a patient who was initiated on pralsetinib for RET mutated NSCLC and subsequently developed reactivation of cytomegalovirus (CMV) viremia and hepatitis B.

Management and outcome: The patient was initiated on valganciclovir and entecavir with subsequent improvement in viral loads. They were able to reinitiate pralsetinib at a lower dose following improvement of CMV and hepatitis B viral load with continuation of entecavir.

Discussion: RET is responsible for activation of several signaling paths including PI3K/AKT and JAK/STAT. Those pathways are involved in the immune system. When reviewing current JAK inhibitors and PI3K inhibitors on the market, there is mixed data on HBV reactivation and CMV viremia, though theoretically possible. Therefore, this should be evaluated and addressed in further studies. The educational value of this case could provide valuable insights for baseline monitoring and management for similarly effected patients.

Introduction: Exposure of healthcare workers to hazardous drugs may result in adverse health effects underscoring the importance of validating working procedures and safety precautions to minimise the risk. The objective was to monitor environmental contamination caused by the hazardous drug workflow: from drug vials, compounding process, to patient administration.

Methods: Surface wipe samples were collected from potentially contaminated surfaces in the compounding department and in the administration department. The outside of drug vials, compounded syringes, bags, elastomeric pumps, and gloves used by the nurses for administration were also monitored. Stationary air samples were collected near the isolators and above the bench top. Personal air samples were collected from pharmacy technicians, pharmacists, and nurses. Monitoring was performed in three trials during two-months. Samples were analysed for cyclophosphamide, 5-fluorouracil, docetaxel, and paclitaxel using liquid chromatography tandem mass spectrometry.

Results: Contamination was mainly found for 5-fluorouracil and cyclophosphamide on isolator surfaces, bench top, trays, and compounded products. Lower levels of contamination were measured in the administration department on trays, trolley arms and gloves of the nurses. Paclitaxel and docetaxel were incidentally detected. Air contamination was found for paclitaxel in the compounding department in one trial, and 5-fluorouracil was detected once in front of an isolator. Docetaxel was found in one air sample of a nurse.

Conclusions: Contamination was mainly found for 5-fluorouracil and cyclophosphamide on the products compounded in the isolators. Contamination was further spread along the workflow towards the administration department causing surfaces in between being contaminated too.

Introduction: The purpose of this study was to assess and compare the effectiveness of seven different closed system transfer device (CSTD) product lines following the 2015 NIOSH Vapor Containment Performance Protocol, using a Gasmet™ DX5000 Terra multigas FTIR analyzer.

Methods: Seven different CSTD systems were assessed using a two-task evaluation on their capacity to contain the NIOSH-specified challenge agent, 70% isopropyl alcohol (IPA). Task 1 simulated reconstitution and compounding steps while Task 2 simulated compounding and administration steps. Vial adapters, syringe adapters, IV bag adapters, and y-site adapters from each CSTD product line were tested. All tasks were performed in a custom-built environmental test chamber as outlined in the 2015 NIOSH protocol, with isopropyl alcohol (IPA) release detected and measured by a Gasmet™ analyzer.

Results: The BD PhaSeal™ CSTD product line effectively contained IPA vapor during both tasks with a task performance metric of 0.00 ppm for each task. BD PhaSeal™ Optima, Equashield^®, Yukon Medical Arisure^®, ICU Medical ChemoLock™, BD Texium™, and ICU Medical ChemoClave™ non-vented CSTDs demonstrated detectable and quantifiable IPA leakage during each task. The leaks occurred at different steps within the protocol, and the amount of IPA vapor detected varied.

Conclusion: In this study, one CSTD product line (i.e., PhaSeal™) successfully contained IPA vapor below the Gasmet™ analyzer's limit of quantification (LOQ) for IPA of 0.04 ppm for both Tasks 1 and 2, demonstrating it to be a validated closed system per the study protocol. All other CSTD product lines demonstrated some level of IPA leakage with task performance metrics above the analyzer's LOQ. However, these results tell us little about how well CSTDs contain hazardous drugs (HDs), as a universal HD surrogate for effectively assessing the closedness of all types of CSTDs has yet to be identified.

Background: Previous research has shown community pharmacists do not have high perceived competence or confidence providing care to patients on oral anti-cancer medications. There is a paucity of evidence when it comes to hospital pharmacists providing care to oncology patients admitted to the hospital for a reason other than cancer.

Objective(s): To assess the perceived competence of hospital pharmacists not working in oncology in managing patients taking anticancer drugs. Additionally, identify factors impacting, potential interventions increasing, and any factors that improve perceived competence.

Methods: An anonymous cross-sectional survey distributed to hospital pharmacists throughout Canada.

Results: Mean perceived competence results ranged from 2.52 to 3.97 out of 7.00 with respondents reporting most perceived competence managing electrolyte disturbances and least competence managing drug-disease interactions and intervening on hepatic dysfunction. Low confidence in knowledge received from previous oncology training was reported with a mean of 2.82 on the 7-point Likert Scale. Continuing education sessions were perceived as the intervention which would most improve perceived competence with a mean value of 5.92 to 5.94 on a 7-point Likert Scale. The number of CE hours completed in the last five years was the only factor shown to have a statistically significant correlation with perceived competence.

Conclusion: Hospital pharmacists do not perceive themselves as competent in providing care to oncology patients. The implementation of a continuing education program related to oncology may improve perceived and actual competence.

Background: Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) have improved the efficacy of endocrine therapy in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) and are now used in both early-stage and metastatic disease. Recent case reports suggest that pseudo-serum creatinine (Scr) elevations are likely a class effect of CDK4/6i.

Methods: This single-center retrospective analysis included patients aged ≥18 years who received at least one dose of palbociclib, ribociclib, or abemaciclib for the treatment of HR+/HER2- BC in the early or advanced setting. The primary objective was the incidence of pseudo-Scr elevation for each of the three agents. CDK4/6i-induced pseudo-Scr elevation was suspected when the Scr elevation could not be fully attributed to other causes. Secondary endpoints included the grade, onset, duration, and clinical consequences of pseudo-Scr elevation.

Results: 143 patients were included. Pseudo-Scr elevation was suspected in patients treated with palbociclib, ribociclib, or abemaciclib, with incidences of 16% (8/50), 14% (6/43), and 20% (10/50), respectively. Rates did not significantly differ between agents (p = 0.727). Among patients with CDK4/6i-induced pseudo-Scr elevation, all events were grade 1 (8.3%) or 2 (91.7%). The median onset from treatment initiation to first Scr elevation was 33.5, 42, and 21.5 days, for palbociclib, ribociclib, or abemaciclib, respectively.

Conclusion: Pseudo-Scr elevation appears to be a class effect of CDK4/6i, with similar rates of Scr elevation observed across the three agents currently FDA approved.