• Evaluation of immune-related adverse events with pembrolizumab for the treatment of advanced metastatic melanoma

      McBride, Ali; Albright, Jason; Briones, Kimberly; Smith, Eric; College of Pharmacy, The University of Arizona (The University of Arizona., 2019)
      Specific Aims: Immune checkpoint inhibitors (CPI) have made breakthrough therapeutic advances in oncology, but are associated with a unique spectrum of side effects. A thorough understanding of immune-related adverse events (irAEs) is vital in reducing mortality and morbidity from immunotherapy. The purpose of this study was to evaluate the irAE profile of pembrolizumab, a PD-1 inhibitor, in melanoma patients treated at The University of Arizona Cancer Center. Methods: We identified patients treated with pembrolizumab for advanced melanoma between 2011 and 2017. Demographics, treatment, irAEs, and hospitalization details were collected. IrAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Results: Of the 64 patients included in this analysis, seven had unresectable stage III and 57 had stage IV melanoma. The median age was 67 with 43 patients (67.2%) being male. In total, 158 irAEs were reported, and 49 out of 64 (76.6%) patients had an irAE. 134 (84.8%) were grade 1 irAEs, 21 (13.3%) were grade 2, whereas grade 3 and 4 were 1.9%. Pruritus (20.9%) was the most common grade 1 to 2 irAE, followed by joint/muscle pain (12.7%) and diarrhea (12.0%). Conclusions: In general, treatment with pembrolizumab at our institution suggests a higher incidence of irAEs per patient compared to previous clinical trials: diarrhea (29.7% vs 14.4%, p=0.004), pruritus (51.6% vs 14.1%, p <0.00001), and rash (25% vs 13.4%, p=0.021), respectively. Most irAEs resolved with appropriate therapy or were self-limiting.