Retrospective study evaluating immune-related adverse events in cancer patients treated with pembrolizumab.

INTRODUCTION: Pembrolizumab has been on the market for several years, but most of the safety data is based on clinical trials with limited literature evaluating post-marketing immune-related adverse events (irAEs) associated with its use. This study aimed to evaluate the characteristics of irAEs associated with pembrolizumab. METHODS: We included adult patients who had received pembrolizumab between January 2016 and December 2020. The patient electronic profiles and the pharmacy adverse event reporting system were reviewed to identify adverse events. Patients were followed from the start of treatment until 12 months after the last dose, end of the study, or death. The characteristics of the patients and the irAEs were recorded. Univariate and multivariate logistic regression analyses were performed to identify variables associated with the development of irAE. RESULTS: During the study period, 223 patients and 1601 cycles of pembrolizumab were evaluated. A total of 67 irAEs were reported in 58 patients. The median age was 53 years (range 18-84), and most patients were males (75%) with metastatic lung cancer (62%). The most common irAEs were respiratory (30%), followed by gastrointestinal (25%), endocrine (24%), and dermatologic (21%). Among the reported irAEs, 28 were associated with hospital admission, 15 required long-term treatment, and 9 resulted in pembrolizumab discontinuation. In logistic regression, there were no significant predictors associated with irAE. CONCLUSIONS: Respiratory irAEs were the most common in our population. We were unable to identify predictors of irAE in this cohort. Further studies are necessary to identify predictors of adverse events.

Impact of Clinical Pharmacy Services on Patient Management in the Chemotherapy Infusion Clinics: A 5-Year Study at a Comprehensive Cancer Center.

BACKGROUND: Chemotherapy requires careful dosing and monitoring and is associated with numerous adverse events. There is limited data describing the impact of clinical pharmacists in the chemotherapy ambulatory setting. OBJECTIVE: This study aimed to evaluate the impact of clinical pharmacy services on patient management in the adult chemotherapy infusion clinics. METHODS: This was a 5-year retrospective study that utilized the pharmacy electronic documentation system to determine the type of interventions and adverse drug events (ADEs) reported by the clinical pharmacists in the chemotherapy infusion clinics. Interventions were described based on the type of intervention and medication involved. ADEs were evaluated based on the type of ADE, the suspected medication, and the required management. RESULTS: During the study period, 3,279 interventions and 1,445 ADEs were reported. The most common interventions involved dose adjustments (51%), followed by addition (23%) or discontinuation (21%) of prescribed medications. Carboplatin (20%) and zoledronic acid (14%) were the most common medications that required pharmacist interventions. The most common types of ADEs were hematologic (22%) and infusion-related reactions (20%). Docetaxel was the most common medication associated with ADEs (20%). Among the reported ADEs, most required adding supportive care (44%), followed by adjusting chemotherapy doses (22%). CONCLUSION: Clinical pharmacy services at the chemotherapy infusion clinics play an important role in optimizing the chemotherapy regimens as well as identifying and managing ADEs. Future studies should be directed to measure the impact of these services on patient outcomes as well as, physicians and pharmacy operational workload and cost savings.