Safety evaluation of fixed‐dose nivolumab in patients with gastric cancer

BACKGROUND AND AIMS: This study aimed to examine the safety of fixed‐dose nivolumab. METHODS: We 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). RESULTS: The 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. CONCLUSION: This is the first report on the safety of nivolumab at 240 mg in Japanese patients.