Association between immune-related adverse events and recurrence-free survival among patients with stage III melanoma randomized to receive pembrolizumab or placebo: A secondary analysis of a randomized clinical trial
JAMA Jan 11, 2020
Eggermont AMM, Kicinski M, Blank CU, et al. - Investigators sought to examine the correlation among immune-related adverse events (irAEs) and recurrence-free survival (RFS) in the double-blind EORTC 1325/KEYNOTE-054 clinical trial comparing pembrolizumab therapy and placebo for the treatment of individuals with high-risk stage III melanoma. They randomly selected a total of 1,019 adults with stage III. Of which 1,011 individuals who began treatment with pembrolizumab therapy or placebo, 622 were males and 389 were females, 386 people were aged 50 to 64 years, 377 were younger than 50 years, and 248 were 65 years and older. Consistent with the reported main analysis in the intent-to-treat population, in comparison with the placebo arm (hazard ratio [HR], 0.56 ), RFS was longer in the pembrolizumab arm, in individuals who started treatment. In the pembrolizumab arm (HR, 0.61), the occurrence of an irAE was correlated with a longer RFS in both males and females. But, in the placebo arm, this correlation was not meaningful. The overall study suggests that in the pembrolizumab arm, the occurrence of an irAE was correlated with a longer RFS.
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