Nivolumab in Resected and Unresectable XXXX : Characteristics of Immune-Related Adverse Events and Association with Outcomes.

@entity1 @entity1910 @entity55 @entity1694 @entity1960 @entity2744 @entity3 @entity320 @entity1349
PURPOSE: Retrospective analysis of irAEs in @entity320 @entity1 treated with nivolumab. EXPERIMENTAL DESIGN: Data were pooled from 148 @entity1 (33 resected, 115 unresectable) treated with nivolumab plus peptide vaccine or nivolumab alone every 2 weeks for 12 weeks. @entity1 with stable disease or regression received an additional 12-week cycle, then nivolumab alone every 12 weeks for up to 2 additional years. Frequency, grade, and characteristics of immune-related adverse events (irAE) were analyzed. A 12-week landmark survival analysis using a multivariate time-dependent Cox proportional hazard model assessed difference in @entity1349 ( @entity1349 ) in the presence or absence of irAEs. RESULTS: IrAEs of any grade were observed in 68.2% of @entity1 (101 of 148). Grade III/IV irAEs were infrequent: 3 (2%) had @entity1910 , 2 (1.35%) had asymptomatic grade III elevation in amylase/lipase, and 2 (1.35%) had @entity1960 . A statistically significant @entity1349 difference was noted among @entity1 with any grade of irAE versus those without (P  <= 0.001), and @entity1349 benefit was noted in @entity1 who reported three or more irAE events (P  <= 0.001). Subset analyses showed statistically significant @entity1349 differences with rash [P = 0.001; HR, 0.423; 95% confidence interval (CI), 0.243-0.735] and @entity1694 (P = 0.012; HR, 0.184; 95% CI, 0.036-0.94). @entity1910 and @entity1694 also correlated with statistically significant @entity1349 differences in @entity1 with @entity3 (P = 0.004 and P = 0.028, respectively). No significant survival differences were seen with other irAEs ( @entity2744 , @entity1960 , or @entity55 ). CONCLUSIONS: Cutaneous irAEs are associated with improved survival in @entity320 @entity1 treated with nivolumab, and clinical benefit should be validated in larger prospective analyses. Clin Cancer Res; 1-9.   2015 AACR.
