Journal of Oncology Pharmacy Practice最新文献

Objectives: The study aimed to: 1) Describe the carboplatin dosing criteria in obese patients in routine clinical practicein a general university hospital. 2) Evaluate toxicity based on the dosing criterion used. 3) Assess effectiveness in major diagnoses according to the dosing criterion employed.

Methodology: An observational, retrospective, descriptive study, including all obese patients (BMI ≥ 30 kg/m²) who started carboplatin treatment between 1^st January 2012 and 31^st January 2015. Data on patient characteristics, disease and treatment were collected. As a result variables were collected: carboplatin dosing methods, dosage criteria, alternative dosing approaches, treatment delays, dose reductions, relative dose intensity, adverse reactions and severity (CTCAE v. 4.0) as well as overall survival and progressive free survival for major diagnoses.

Conclusions: 1) Carboplatin dosing at the centre used Calvert's formula for calculating AUC and Cockcroft-Gault's formula for estimating glomerular filtration rate. 2) Cockcroft-Gault's formula employed actual body weight and ideal adjusted body weight in similar proportions. 3) The ideal adjusted body weight was more commonly used in patients with higher obesity and diabetes. 4) In the general population, the developmental trend of toxicity during treatment was greater in the group dosed by actual body weight, reaching significant differences in thrombopenia, neutropenia, GOT elevation, hyporexia and myalgias. 5) Major diagnoses in the present study were ovarian cancer and non-small cell lung cancer. The effectiveness in terms of overall survival and progression-free survival, comparing the groups dosed by actual body weight and ideal adjusted body weight within each pathology did not show statistically significant differences.

Purpose: To examine the feasibility and utility of a clinical pharmacist-led multidisciplinary deprescribing intervention in hospitalized cancer patients.

Methods: We performed a retrospective cohort study among cancer patients hospitalized in oncology department who underwent a medication review by a clinical pharmacist. The pharmacist's recommendations were evaluated by a multidisciplinary team. We collected demographic and clinical information, including information on medication burden before and after intervention and number and types of deprescribing recommendations and their acceptance, and compared them among patients with different estimated life expectancies.

Results: During a 2-year study period, 392 patients evaluated by the clinical pharmacist received 2808 prescriptions (median, 7 per patient). The clinical pharmacist recommended deprescribing of 559 medications (19.9%; 95 CI, 18.4-21.4%), at least 1 medication in 321 patients (82%). The multidisciplinary team accepted 89.6% of deprescribing recommendations, resulting in a reduction of the medication burden by 501 medications (P < 0.001). 12.8% of deprescriptions addressed clinically manifested adverse drug effects in 15.1% of patients. The estimation of life expectancy by the senior oncologist was reasonably accurate, but did not affect deprescribing rate.

Conclusions: A clinical pharmacist-led deprescribing intervention within a multidisciplinary team effectively reduces medication burden and addresses adverse drug effects in cancer patients. Deprescribing interventions should be incorporated in cancer patients at any stage of the disease.

Introduction: There exists some apprehension by prescribers, healthcare providers, and other stakeholders regarding the real-world safety and effectiveness of biosimilars. While some of the apprehension is likely due to clinician knowledge gaps in the biosimilarity exercise, additional data (including those generated from the real-world) regarding safety and efficacy could reduce a clinician's perception of biosimilar uncertainty and can potentially increase biosimilar acceptance and uptake. The published literature is lacking regarding the real-world impact on healthcare costs and clinical outcomes when a single healthcare institution converts from filgrastim to filgrastim-sndz as its short-acting Granulocyte Colony Stimulating Factor (GCSF), especially within diverse populations and indications not explicitly studied through the registration trials. Specifically, both filgrastim and filgrastim-sndz possess FDA-approved indications within patients with hematologic malignancies receiving high-dose chemotherapy and in those undergoing bone marrow transplantation. As a biosimilar to filgrastim, the FDA did not require prospective, randomized controlled trials to obtain these indications for filgrastim-sndz. The purpose of this study is to describe real-world healthcare resource costs, utilization patterns, and clinical outcomes in patients with hematologic malignancies who received filgrastim-sndz or filgrastim to support neutrophil recovery following chemotherapy (i.e., induction or consolidation) or a bone marrow transplant (BMT) at Yale New Haven Hospital (YNHH).

Methods: A total of 148 patients were identified and met the following criteria: at least 18 years old, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, absence of fever or infection, newly diagnosed acute myeloid leukemia or newly post-bone marrow transplant and received filgrastim-sndz (Zarxio^®) or reference filgrastim (Neupogen^®).

Results: Healthcare resource utilization outcomes were compared between biosimilar and reference filgrastim using descriptive statistics. There were no major differences between either cohort, including duration of hospitalization, the number of overall emergency room visits and additional hospital admissions with a primary diagnosis of febrile neutropenia or neutropenia within 30 days post-discharge from initial hospital admission, time to neutrophil recovery following GCSF support, and the incidence and duration of both fever and febrile neutropenia. The total cost based on treatment of all patients in each arm differed significantly with filgrastim-sndz being the most cost-effective choice.

Conclusion: filgrastim-sndz significantly reduced healthcare utilization costs compared to reference filgrastim with similar effect on absolute neutrophil count, incidence of fever, and febrile neutropenia.

Introduction: Second-generation androgen receptor antagonists, including enzalutamide, apalutamide, and darolutamide, are commonly used to treat metastatic and non-metastatic prostate cancer. Although these medications are typically well-tolerated, falls were reported in 4.2-15.6% of patients and fractures in 4.2-11.7% of patients enrolled in the phase III clinical trials evaluating these drugs in prostate cancer. However, post-marketing studies have reported a lower incidence than reported in clinical trials. The objective of this study is to determine the prevalence of falls and fractures in patients with prostate cancer receiving second-generation androgen receptor antagonists at UConn Health and identify potential risk factors associated with falls and fractures in these patients.

Methods: A retrospective chart review involving patients with prostate cancer treated with darolutamide, enzalutamide, or apalutamide from March 1, 2022, to March 31, 2023, at UConn Health Carole & Ray Neag Comprehensive Cancer Center. Data recorded includes basic demographics, history of fall or fracture, presence of metastases, fall risk, history of osteoporosis, prescribed second-generation androgen receptor antagonist, and other comorbidities. Data was evaluated using descriptive statistics.

Results: Twenty-six men were included, all of whom were receiving enzalutamide. At baseline, 96.1% of patients had bone metastases, 15.4% had osteoporosis, 15.4% had osteopenia, and 34.6% had neuropathy. The incidence of falls was 19.2% and the incidence of fractures was 26.9%. The mean length of therapy at time of a fall was 19.44 months (range, 6-31 months). The mean length of therapy at time of a fracture was 19 months (range, 1-33 months). In patients experiencing fall, 100% had arthralgia, 60% had neuropathy, 40% had a gait problem, 40% had hypertension, and 80% of them were at risk of fall. In patients experiencing fracture, 28.6% had osteoporosis, 42.9% had osteopenia, 100% had bone metastases, and 57.1% were on denosumab at time of fracture.

Conclusion: The prevalence of falls and fractures in patients receiving enzalutamide were higher in this retrospective chart review than reported in clinical trials and post-marketing studies. This could be due to the small patient population or the patient's comorbidities such as osteoporosis, bone metastases, or neuropathy. Fall/fracture risk with enzalutamide and other risk factors for fall and fracture should be considered when discussing treatment and developing a monitoring plan.

Introduction: Hypomagnesemia is a common issue in patients with cancer due to magnesium wasting drugs like calcineurin inhibitors, chemotherapy sides effects such as diarrhea, and poor oral intake. Historically, magnesium has been given over prolonged infusions due to concern for rapid elimination of magnesium when large doses are administered. At UW Health, magnesium was given at a rate of 1g/60 min. A prolonged infusion rate often creates logistical issues including limited IV access, incompatibility concerns and increased chair time. The purpose of this project is to increase the infusion rate of IV magnesium without compromising therapeutic repletion, benefit, and safety.

Methods: The magnesium infusion rate was increased to the following rates: 4g/60 min, 2g/30 min, 1g/15 min. The primary outcome is the grams of IV magnesium replaced per outpatient visit between the pre-intervention (prolonged) and post-intervention (rapid) groups. Secondary outcomes include assessment of differences in chair time between groups and total incidence of critical magnesium lab values.

Results: There was no statistically significant difference in magnesium requirements per outpatient visit between a prolonged and rapid magnesium infusion rate (2.18g vs 2.15g; p = 0.49). Additionally, there was no difference in number of outpatient visits (3 vs 3; p = 1). The average chair time was decreased by 110 min per outpatient encounter between the prolonged and rapid magnesium infusion rate, which was determined to be clinically and statistically significant.

Conclusion: This study suggests that there is no difference in magnesium requirements between a rapid or prolonged magnesium infusion in both solid and liquid tumor patients.

Background: Adherence to chemotherapy regimens is crucial for achieving optimal treatment outcomes in cancer patients. However, measuring adherence remains a significant challenge. This study aimed to develop and validate a comprehensive self-report tool for assessing chemotherapy adherence.

Methods: The Chemotherapy Adherence Assessment Scale (CAAS) was developed through a multi-stage process involving literature review, expert input, and pilot testing. Face validation was conducted with 23 subject experts, and content validity was assessed using the Content Validity Index (CVI). The CAAS was pilot-tested on 28 cancer patients undergoing chemotherapy. Psychometric properties were evaluated through internal consistency analysis (Cronbach's alpha) and Exploratory Factor Analysis (EFA).

Results: Face validation revealed 85% agreement among experts regarding grammar, clarity, and content. The CVI was 0.81 for individual items and 0.83 for the overall scale, indicating good content validity. Cronbach's alpha was 0.789, demonstrating strong internal consistency. The EFA yielded a robust five-factor structure, explaining 94.63% of the total variance. Most items exhibited strong factor loadings (>0.7) and high communalities (>0.7), supporting the construct validity of the CAAS.

Conclusions: The CAAS demonstrated robust psychometric properties, including good content validity, high internal consistency, and a well-defined factor structure capturing key dimensions of chemotherapy adherence. The CAAS represents a valuable contribution to adherence assessment in oncology settings, with potential applications in clinical practice and adherence interventions.

Introduction: Monoclonal antibodies represent a significant improvement in the treatment of the HER2 + metastatic cancer, which is associated with a worse prognosis. The objective of this study was to compare overall survival (OS) data in patients treated with trastuzumab + pertuzumab followed by trastuzumab-emtansine (T-DM1) in the second line of metastatic treatment (Arm A) versus patients treated with trastuzumab alone (Arm B). Progression-free survival (PFS) in first-line metastatic patients was also compared in both arms. Methods: This single-center retrospective study included patients from February 2008 to August 2022. OS and PFS of both arms were described and estimated using the Kaplan-Meier method. Data were extracted from electronic medical records and CHIMIO prescribing software. Results: The total duration of metastatic treatment of the 82 patients was significantly longer in the arm A (43.2 ± 28 months vs 33.6 ± 28.9 months), as was the median time to death (59 vs 52 months). The OS data showed a significant reduction in the risk of death in the arm A (Hazard Ratio = 0.59; 95% Confidence Interval [0.37-0.94]; p = 0.02). No difference was shown for PFS. Conclusion: The trastuzumab/pertuzumab/T-DM1 combination showed a significant improvement in OS. Our results are in line with the CLEOPATRA and EMILIA studies, but long-term responders in the arm A may have impacted our results. The absence of difference in term of PFS in first metastatic line may be explained by a selection bias, as patients in the arm A potentially have more aggressive forms.

Background: The CREATE-X trial demonstrated that adjuvant capecitabine was effective in prolonging survival in high-risk triple-negative breast cancer (TNBC) patients. However, the recommended dose is generally not well tolerated by the US population. The goal of this study is to analyze dosing patterns in an ethnically diverse cohort to better characterize tolerability and inform future dosing guidelines.

Methods: In our single-center retrospective study, we evaluated safety and tolerability in TNBC patients undergoing adjuvant capecitabine treatment. The primary endpoint, relative dose intensity (RDI) across eight cycles, was examined alongside subgroup analyses based on age, race, BMI, and initial dose. Secondary endpoints include capecitabine-related side effects and survival.

Results: 67 patients who completed adjuvant capecitabine at University of Chicago Medicine (UCM) between January 2017 and November 2022 were eligible. The mean RDI across eight cycles of treatment was 60.2% (95% CI: 0.554-0.650). When compared to the CREATE-X trial, the RDI in our population was significantly lower (0.602 vs. 0.787, p < 0.001). There was no statistically significant difference in average RDI across eight cycles for patients stratified by age, BMI, race, or initial starting dose. The most frequently reported adverse events were hand-foot syndrome (73%), diarrhea (27%), and fatigue (22%), consistent with prior studies.

Conclusions: Our data demonstrates that a significant portion of patients have a lower tolerated dose of capecitabine in comparison to the recommended adjuvant dose. Acknowledging the limitations of our single-center analysis, RDI was not significantly affected by age, race, BMI, or initial starting dose.

Introduction: The demand for oncology pharmacy services is set to increase as the burden of cancer rises in sub-Saharan Africa. Oncology pharmacists may be exposed to antineoplastic drugs (ADs) and need comprehensive health and safety guidelines. The objective of the study was to assess the effectiveness of the local oncology pharmacy practice standards, by critically evaluating them against international best practice standards.

Methods: We compared the Independent Clinical Oncology Network (ICON) administration of ADs standards resource document (ICON standards) and Good Pharmacy Practice (GPP) standards with the International Society of Oncology Pharmacy Practitioners (ISOPP) Standards for the safe handling of cytotoxics, and the Quality standard for the oncology pharmacy service (QuaPos), using 10 domains: transport of ADs, working arrangements, education and training, engineering controls, use of personal protective equipment, risk management, medical monitoring of personnel, cleaning procedures, accident management and documentation, labelling and checking procedures.

Results: The ICON standards align closely with international best practice standards, but the GPP standards focus only briefly on the compounding of ADs.The GPP standards are outdated and some of the stipulations are erroneous. Oncology pharmacists would do better to adhere to the more comprehensive ICON standards, although these standards also need to be updated in line with best practice.

Conclusion: Revising and improving both these local standards in consultation with key role players in the oncology pharmacy industry will go a long way in protecting the health and safety of oncology pharmacists in South Africa.

Objective: To develop a sustainable three-step method for titrating first and second taxane exposures through integration of best practices in patient and environmental safety; and to evaluate the impact on immediate hypersensitivity rates.

Methods: A quality improvement study was initiated at a large, NCI-designated comprehensive cancer center in the U.S. to determine a sustainable method of slow, upward titration for reducing taxane-related hypersensitivity reactions. Multidisciplinary collaboration led to the incorporation of best practices for safe preparation and administration of high risk, hazardous drugs. Retrospective data from the electronic health records of 690 patients who received 1221 taxane doses were analyzed. Non-titrated infusions were compared with infusions titrated using a method initially tested for efficacy; and infusions titrated using a method revised for greater compliance with safety standards. Two-sided Fisher's exact tests at a 0.1 level of significance were used to detect differences in the rate of HSR between the three groups.

Results: A method of taxane titration that incorporated standardized, preprogrammed infusion rates and tubing primed with inert IV fluid showed a significant reduction in HSR incidence in comparison to non-titrated infusions (6% v. 19%, P = 0.001) and a similar decrease in the rate of HSR (6%) to the initial method previously studied (7%) (P = 0.659) which was not sustainable due to patient and environmental safety concerns.

Conclusions: A three-step titration method using standardized, preprogrammed infusion rates and tubing primed with inert IV fluid reduced taxane-related HSRs and was adopted as sustainable practice in ambulatory cancer care.