Safety evaluation of fixed-dose nivolumab in patients with gastric cancer.

Abstract

Background and AimsThis study aimed to examine the safety of fixed‐dose nivolumab.MethodsWe retrospectively reviewed the medical records of 113 Japanese patients with gastric cancer who were previously treated with cytotoxic chemotherapy and initiated nivolumab. The endpoints were the incidence of Grade 2 or higher immune‐related adverse events (irAEs) in the conventional dose (3 mg/kg) and fixed‐dose groups (240 mg).ResultsThe incidence rates of irAEs in the conventional‐dose and fixed‐dose groups were 29.9% and 19.4%, respectively, and the rates of Grade 2 or higher irAEs were 23.3% and 19.4%, respectively, with no significant difference between the two groups, suggesting that nivolumab at 240 mg is as safe as the 3 mg/kg dose.ConclusionThis is the first report on the safety of nivolumab at 240 mg in Japanese patients.