Journal of Oncology Pharmacy Practice最新文献

Introduction: Intravenous (IV) medications can be prepared using compounding devices to increase productivity, and reduce risks associated with aseptic compounding. This study evaluated the productivity and quality outcomes of the aseptic process for simulated batches of IV medications used in clinical practice produced using a semi-automated compounding device (Gri-fill; Grifols).

Methods: Simulated batches from 50 to 600 preparations were completed representing hazardous and non-hazardous drugs, including one-step single component (atropine sulfate, cisplatin) and multistep, multiple component (mitomycin C, piperacillin/tazobactam, trastuzumab, 5-fluorouracil and gemcitabine). Productivity, device autonomy, quality of the aseptic process (media-fill test) and sterility of the preparations were evaluated.

Results: A total of 2024 final preparations and 460 intermediate products were compounded during 78 working hours. For low and high complexity level preparations, median (minimum-maximum) production speed was 1.3 (0.6-1.7) and 3.7 (2.6-4.3) min per preparation, respectively. The longest process (36.2 min/bag) was the preparation of a simulated gemcitabine 3 L bulk solution bag, which included reconstitution of vials and filling the bulk bag. All operational errors (0.6%) were resolved autonomously by the user. None of the 883 media fill preparations showed microbiological growth and all 114 analyzed preparations passed the sterility test.

Conclusions: Using a semi-automated compounding device, preparation efficiency of IV medications ranged from 14 preparations/h for multicomponent preparations from vials requiring reconstitution, to 100 preparations/h for low complexity preparations using a bulk solution bag. The aseptic processes demonstrated the absence of microbial growth in all tested preparations.

Introduction: Treatment advances for hematologic malignancies (HM) have dramatically improved life expectancy, necessitating greater focus on long-term cancer pain management. This study explored real-world patterns of opioid use among patients with HM.

Methods: This retrospective cohort study identified adults diagnosed with HM from January 1, 2013 through December 31, 2019 using the Truven MarketScan Commercial Claims and Encounters database. Across several HM types, we described rates of high-risk opioid use (based on Pharmacy Quality Alliance measures) and opioid-related harms, including incident opioid use disorder (OUD) diagnoses and opioid-related hospitalizations or emergency department (ED) visits. We used multivariable Cox regression to generate adjusted hazard ratios and 95% confidence intervals comparing the risk of opioid-related harms between patients with versus without high-risk opioid use.

Results: Our sample included 43,190 patients with HM. Median age at HM diagnosis was 54 years (interquartile range  =  44-60). Most patients (61.9%) were diagnosed with lymphoma. Approximately half (49.2%) had an opioid dispensed in the follow-up period. Among all patients, 20.0% met criteria for high-risk opioid use, 0.9% had an OUD diagnosis, and 0.3% experienced an opioid-related hospitalization/ED visit in follow-up. High-risk opioid use increased the risk of an OUD diagnosis by 3.3 times (p < 0.0001) and an opioid-related hospitalization/ED visit 4.2 times (p < 0.0001).

Conclusion: High-risk opioid use was prevalent among patients with HM and significantly increased the risk of opioid-related harms. However, rates of opioid-related harms were low. These findings highlight the importance of continually monitoring pain and opioid use throughout HM survivorship to provide safe, effective HM pain management.

Introduction: To date, there is no adherence estimator to identify risk of nonadherence prior to initiating oral oncolytics.

Methods: A workgroup was assembled through the National Community Oncology Dispensing Association and tasked with creating a tool to meet this need. Tool constructs were defined after a review of the literature identifying top barriers to adherence. A second literature search was conducted to identify questions targeting specific barriers from validated adherence questionnaires. Once a finalized draft was complete, the risk assessment tool was built into an electronic survey where a risk category can be automatically calculated for the patient.

Results: The six most impactful factors affecting compliance to oral oncolytics were identified as patient's confidence, health literacy, perception of treatment, quality of life, social support, and complexity of chemotherapy regimen. A six-item questionnaire was created with five patient-directed questions and one clinician-directed question. Examples and descriptions were provided for clinicians to consider when categorizing complexity of a regimen. The tool was designed for responses to each question to be indexed into categories through a 10-point system. Results will be stratified into low, moderate, or high risk for nonadherence.

Conclusion: The creation of a tool to predict nonadherence prior to starting therapy is an unmet need for patients initiating oral oncolytics. The aim of this tool is to meet those needs and better guide clinicians to provide patients with strategies to better manage nonadherence. Next steps include tool validation and piloting in clinical practice.

Introduction: Pembrolizumab is a monoclonal PD-1 inhibitor used in the treatment of lung cancer in addition to several other malignancies. Psoriasiform dermatitis is a well-documented adverse effect.

Case report: We present a 68 year-old-male with a 50-year smoking history and a 30-year remote history of plaque psoriasis, limited to the knees and elbows, who presented with metastatic non-small cell lung cancer. He was started on a chemotherapy regimen of carboplatin, paclitaxel, and pembrolizumab. One month later, he presented to dermatology with diffuse erythematous scaly papules coalescing into plaques on 80% of body surface area (BSA).

Management & outcome: Pembrolizumab treatment was paused. The patient was prescribed triamcinolone 0.1% twice daily, but still had significant BSA at one-month and was started on an Il-17 inhibitor, ixekizumab, clearing the psoriasiform dermatitis. He was rechallenged with pembrolizumab every 3 weeks and repeat PET/CT demonstrated excellent tumor response.

Discussion: This case prompted a literature review to further characterize the use of IL-17 inhibitors for psoriasiform dermatitis in the setting of ICI therapy. All six cases demonstrated improvement of psoriasiform dermatitis, with two cases showing partial response and four cases showing complete resolution. In three of the six cases, the patients exhibited clinical response to the primary malignancy after rechallenging with ICI, while remaining on an IL-17 inhibitor. Our case, in conjunction with the other reported cases, seems to suggest that IL-17 blockade can maintain a fine balance in this challenging clinical scenario by treating psoriasiform dermatitis without compromising the efficacy of immunotherapy.

Background: With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education.

Objective: To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration.

Discussion: A multidisciplinary effort is required to attain FACT certification and implement pharmacist compounding of cellular therapy products.¹ Local preparation within a pharmacy facilitates a sound operational workflow and provides a pathway to perform aseptic manipulations of cellular therapy products safely and efficiently.

Conclusion: Safe and successful administration of cellular therapies handled and compounded by pharmacy department staff along with program validation requires a preemptive review utilizing a multidisciplinary approach for process development. This manuscript will provide a foundation based on consistency and transparency in effective cellular therapy sterile compounding and aseptic manipulation, proper handling and disposal procedures, increased communication through creation and optimization of treatment plans and order-sets, standardized medical center staff education, and development of policies and standard operating procedures for the entire health care team.

Objective: Dostarlimab, a humanized monoclonal PD-1 blocking antibody, is being tested as a cancer therapy in this review. Specifically, it addresses mismatch repair failure in endometrial cancer and locally progressed rectal cancer patients.

Data sources: A thorough database search found Dostarlimab clinical trials and studies. Published publications and ongoing clinical trials on Dostarlimab's efficacy as a single therapy and in conjunction with other medicines across cancer types were searched.

Data summary: The review recommends Dostarlimab for endometrial cancer mismatch repair failure, as supported by GARNET studies. The analysis also highlights locally advanced rectal cancer findings. In the evolving area of cancer therapy, immune checkpoint inhibitors including pembrolizumab, avelumab, atezolizumab, nivolumab, and durvalumab were discussed.

Conclusions: Locally advanced rectal cancer patients responded 100% to Dostarlimab. Many clinical trials, including ROSCAN, AMBER, IOLite, CITRINO, JASPER, OPAL, PRIME, PERLA, and others, are investigating Dostarlimab in combination treatment. This research sheds light on Dostarlimab's current and future possibilities, in improving cancer immunotherapy understanding.

Introduction: In recent years, most molecular target drugs have been administered orally, as prescribed at ambulatory services in hospitals and at patients' homes. Telephone follow-up is increasingly being used in clinical practice for patients needing additional support post-discharge and for the prevention of hospital readmissions. The purpose of this study was to clarify the clinical benefits of telephone follow-up while administering oral anticancer drugs.

Methods: This was a single-center, observational, retrospective study. We evaluated hepatocellular carcinoma patients who received sorafenib or lenvatinib between March 2010 and February 2018. The primary endpoint was the incidence of adverse events.

Results: From the total of 130 patients, 83 patients received telephone follow-up and 47 did not. The incidence of hand-foot skin reactions significantly reduced in patients with telephone follow-up (odds ratio (OR) 3.69, 95% confidence interval (CI) 1.16-11.8, p = 0.020). The median durations (ranges) of adherence to oral chemotherapy were 259 days (15-1730) for the telephone follow-up group and 121 days (14-1105) for the no-telephone follow-up group (p < 0.001). Moreover, the disease control rate was significantly higher in the telephone follow-up group (OR 2.52, 95% CI 1.15-5.53, p = 0.020).

Conclusions: Remote interventions, such as telephone follow-up, are useful means of managing adverse events in patients receiving oral anticancer drugs and can lead to improved treatment results.

Introduction: Patients diagnosed with cancer are at an increased risk of infection. Vaccines remain one of the most critical public health strategies in limiting infectious diseases, with a heightened importance in cancer patients. Data across the general US population indicates that vaccine adherence rates are suboptimal across all adult vaccine schedules. This study aims to define vaccine adherence rates within the oncology population.

Methods: This retrospective cohort study includes adult patients with a new cancer diagnosis. Vaccine administrations for COVID-19 (SARS-CoV-2), influenza, pneumococcal, tetanus/diphtheria/pertussis (TDaP), herpes zoster (RZV), human papillomavirus (HPV), and hepatitis B (hepB) were assessed. The primary outcome was complete vaccine adherence.

Results: Two hundred and eighty-three oncology patients were included. The median age at diagnosis was 63 years old, and most subjects were females (60%). The two most common malignancies were gastrointestinal and breast cancer at 26.5% and 15.2%, respectively. Suboptimal vaccine adherence rates were observed across the entire oncology population. Complete adherence was observed in only 1.4% of patients. Vaccine specific adherence rates were as follows, SARS-CoV-2: 38.9%; influenza: 11.4%; pneumococcal: 12.7%; TDaP: 13.1%; RZV: 3.5%; HPV: 0%; and hepB: 34%. Among the vaccine schedules assessed, SARS-CoV-2 vaccination rates were the highest with 38.9% of patients being fully adherent and 73% receiving at least one dose.

Conclusion: Lower vaccine adherence rates were observed in oncology patients compared to currently published rates. Providers and pharmacists can play a role in assessing and counseling patients on the importance of vaccine adherence before chemotherapy is initiated and after a remission is obtained.

Introduction: Cyclin-dependent kinase (CDK) 4/6 inhibitors have significantly changed the treatment strategy for patients with locally advanced or metastatic hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2) breast cancer. The purpose of the study was to determine the prevalence of drug-drug interactions (DDI) in breast cancer patients using CDK 4/6 inhibitors and the extent of DDI reflected in the clinic and to increase clinical awareness among physicians.

Method: The data of 115 metastatic breast cancer patients using CDK 4/6 inhibitors who were admitted to the Medical Oncology outpatient clinic between July 2021 and July 2023 were retrospectively reviewed. The Drugs.com® Drug Interaction Checker application was used for the interaction between the CDK 4/6 inhibitor and other drugs.

Results: Among patients included in the study, 97.3% had at least one additional drug use. We have identified a total of 170 potential DDI risks in 63.5 % of patients. Among these, 50.5% had a major potential DDI. In our study, there was a potential risk of QT prolongation in 45.2% of 170 DDI, an increase in the potential toxicity of the additional drug in 44.1%, an increase in the potential toxicity of the CDK 4/6 inhibitor in 5.3%, a decrease in the potential efficacy of the CDK 4/6 inhibitor in 2.9%, a decrease in the potential efficacy of the additional drug in 1.1%, and a serious potential infection risk in 1.1%. Most of the drug interactions were QT prolongation and increased toxicity of the additional drug. In terms of cardiovascular events, grade-2 and grade-3 QTc prolongation was found in 4.3% and 1.7% of these interactions, respectively. When evaluated in terms of CDK 4/6 inhibitor subtype, there was a potential risk of DDI at major level with Ribocilib and at moderate level with Palbociclib.

Conclusion: If CDK 4/6 inhibitors interact with concomitant drugs, they may cause an increase in the incidence of cardiac side effects and a decrease in the effect of the CDK 4/6 inhibitor or additional drug or an increase in toxicity. Increasing awareness of this issue will help to reduce the rates of side effects or toxicity and provide effective antitumour therapy.

Background: In recent years, a new type of immediate hypersensitivity reaction known as cytokine release began to emerge, and within this phenotype of reactions, interleukin-6 is the most frequently associated with the presence during drug administration. Chemotherapeutic agents (QT) and monoclonal antibodies.

Objective: Determine interleukin-6 levels in hypersensitivity reactions to QT and monoclonal antibodies.

Methods: Observational and prospective study that was carried out from March 1, 2021 to March 1, 2022 in a university hospital in northeastern Mexico. Symptoms, severity, interleukin-6 levels, and skin tests of hypersensitivity reaction were evaluated at QT and monoclonal antibodies.

Results: A total of 41 patients with oncological disease were included, the most frequent being ovarian cancer. Symptoms as initial hypersensitivity reaction were neuromuscular in taxanes and cutaneous in Platinums.41.5% presented elevation of interleukin-6, and it was found more frequently in presence of metastases. Positive skin tests were found more frequently in the carboplatin and doxorubicin groups. The most frequently presented phenotype was type I in paclitaxel, carboplatin, and doxorubicin, and mixed-reaction (type I and cytokine release) in oxaliplatin.

Conclusion: With the increasing prevalence of hypersensitivity reactions to biologic and antineoplastic therapies, interleukin-6 should be recognized as a biomarker in immediate hypersensitivity reactions to QT and monoclonal antibodies.