Journal of Oncology Pharmacy Practice最新文献

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.

Introduction: 5-azacitidine is a hypomethylating agent (HMA) used for treating myelodysplastic syndrome (MDS) and certain myeloproliferative neoplasms (MPNs). Common side effects include myelosuppression, nausea and injection site reactions. Serious allergic reactions are rare with this class of agents.

Case report: We describe a 71-year-old man with MDS/MPN who developed repeated episodes of angioedema after starting treatment with subcutaneous 5-azacitidine. Angioedema involved multiple body areas including the neck, genitalia, lower back and gastrointestinal system. Causality assessment linked this entity to 5-azacitidine via the Naranjo nomogram questionnaire, by scoring 9.

Management and outcome: 5-azacitidine was discontinued due to recurrent episodes of angioedema that occurred even after dose reduction. Steroids were helpful in terms of reversing this reaction. Afterwards, no further episodes of angioedema have been documented. The patient's thrombocytosis is currently well-controlled with low dose hydroxyurea.

Discussion/conclusion: We report herein a unique case of recurrent, multisystem angioedema likely related to 5-azacitidine. The exact mechanism of azacitidine-induced angioedema is not currently known. Symptoms, clinical findings and timing of presentation are not always clear-cut, and it may take more than one cycle of 5-azacitidine before the diagnosis is made. Supportive and symptomatic treatment will be provided based on the severity of the reaction. Future studies may offer more insights into the mechanism underlying this rare and serious, yet intriguing side effect.

Introduction: To minimize the risk of hypersensitivity reactions (HSRs) caused by paclitaxel infusion, premedication with corticosteroid, H1-antagonist and H2 antagonist (ranitidine) was standard of care. Discontinuation of ranitidine in 2020 led to adjustments in premedication regimens and a new regimen without ranitidine was implemented in our center. This study aimed to compare the incidence of HSRs during paclitaxel treatment of a standard premedication regimen including ranitidine with a new premedication regimen without ranitidine and with a titrated infusion rate during the first two administrations.

Methods: Retrospective data analysis was performed on two cohorts of adult patients with solid tumors who started treatment with paclitaxel and received a premedication regimen with and without ranitidine over the years 2021 and 2023 respectively (before and after ranitidine withdrawal). Univariable and multivariable logistic regression models were used to investigate any associations with H2 antagonist treatment adjusting for confounding variables.

Results: A total of 319 patients were included. 158 patients received the standard premedication regimen with ranitidine compared to 161 patients who did not received ranitidine. HSRs were observed in 10 of 1101 administrations of paclitaxel (0,90%) in ranitidine group compared to 2 of 899 (0,22%) in the ranitidine-free cohort (p = 0.048). Analysis incidence per patient also found results with statistically significant differences: 5.7% (9 of 158 patients) in the ranitidine cohort compared to 1.2% (2 of 161 patients) in the ranitidine-free cohort (p = 0.029).

Conclusions: The results of the study show the effectiveness of a premedication regimen including only dexchlorpherinamine and dexamethasone, along with a titrated infusion rate during the first two administrations, in reducing the incidence of paclitaxed-induced HSRs.

Introduction: 5-Fluorouracil (5-FU) is a chemotherapeutic agent used to treat various types of cancers. Although widely used, it has consistently been attributed to cardiotoxicities after administration. The purpose of this study was to assess the parameters and predictors of cardiotoxicities associated with various 5-FU-based chemotherapeutic protocols in patients with GI/colorectal cancer, as well as the correlation of these cardiotoxic events with age, sex, cumulative dose, and risk factors such as obesity, hypertension, and family history of cardiac diseases.

Methods: A prospective study consisting of 396 patients of both sexes was conducted in the oncology ward of Nishtar Hospital in Multan, Pakistan. Patients were grouped according to the therapeutic protocol they received (5-FU monotherapy or in combination, with different dosing regimens). Electrocardiography and serum troponin levels were used to assess 5-FU-induced cardiotoxicity. In cases where cardiotoxicity was detected, 5-FU treatment was interrupted; nitroglycerin, nitrates, and calcium channel blockers were administered; and cardiac monitoring was initiated. 5-FU was discontinued in all cases of acute myocardial infarction.

Results: Of the 396 patients, 28.5% reported different cardiotoxic symptoms after receiving various 5-FU-containing protocols. 35% had anginal pain, 13% suffered a myocardial infarction, 11% developed hypertension, and 10% presented heart failure. Patients receiving 5-FU combination therapy showed cardiotoxic events that were significantly different from those on 5-FU monotherapy. Based on the ECG results, only the QTc-d interval increased significantly (p < 0.001) after therapy. 68% of the patients had troponin levels > 2 ng/mL at the end of treatment.

Conclusions: Pre-existing cardiac diseases, treatment duration, smoking, and obesity were found to be influential components in the development of cardiotoxicity, and patients with cancer should be closely monitored during 5-FU chemotherapy.

Objective: Most intravenous anticancer drugs are administered in a dose per unit area or body weight, if not promptly administered to another patient cytotoxic leftover would be destroyed. To contain wastage, low-cost measures are highly desirable to contain and reduce expenditures without impairing the quality of care. The objective of the study is to evaluate the cost saved through the use of the two cytotoxic waste management techniques implemented in National Institute of Oncology's centralized chemotherapy preparation unit, vial sharing and dose rounding.

Method: A 6-month prospective single centre study from 1 February to 1 August 2023 at the National Institute of Oncology of Rabat in Morocco. The number of prepared preparations and amount of drug saved by both vial sharing and dose rounding was collected using the centralized chemotherapy preparation unit's 'leftover tracking file', the corresponding cost saved were calculated and then compared for each technique and with 2018 results.

Results: In total, 18,218 preparations were considered in the 6-month study. With the vial sharing technique 636,524.5 mg were saved corresponding to 246,031.4 (USD) saved cost, against 212,838.4 mg by dose rounding corresponding to 75,598.5 (USD) saved cost. This saving corresponded to a total of 321,629.4 (USD). Compared to the 2018 results leftovers costs saved by vial sharing corresponded to 289,972.05 (USD) by vial sharing technique for 1-year extrapolated period, and this study shows a saved cost of 321,629.9 (USD) by both vial sharing and dose rounding techniques.

Conclusion: Dose rounding technique combined with vial sharing allowed National Institute of Oncology's centralized chemotherapy preparation unit to limit expensive cytotoxic cost wastage, highlighting these technique benefits.

Introduction: Fanconi anemia (FA) is a genetic disorder characterized by bone marrow failure typically developing in the first decade of life, congenital abnormalities, and an increased predisposition to malignancy. However, patients with FA can remain undiagnosed until adulthood and present with solid organ malignancies. Due to impaired DNA repair mechanisms, patients with FA are highly susceptible to severe bone marrow toxicity when treated with cisplatin.

Case report: A 38-year-old woman, diagnosed with locally advanced squamous cell carcinoma (SCC) of the uterine cervix, underwent treatment with weekly cisplatin concurrent with radiotherapy. After the second week of cisplatin treatment, she presented with severe pancytopenia. The prolonged and severe pancytopenia following cisplatin and radiation, along with cervical SCC in the absence of risk factors and the presence of parental consanguinity, raised the possibility of FA as the underlying cause. Whole exome sequencing revealed a homozygous FANCI c.668A > C (p.Lys223Thr) missense variant confirming the diagnosis of FA.

Management and outcome: The pancytopenia exhibited a protracted course, necessitating admission and supportive treatment with antibiotics, red blood cell and platelet transfusions, as well as filgrastim and eltrombopag. Eventually, the pancytopenia improved after approximately 40 days of hospitalization.

Discussion: SCC of the head and neck or gynecologic organs in a young adult without known risk factors should prompt consideration of FA. Cisplatin should be avoided in patients with FA.