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.
Keywords: fixed dose; gastric cancer; immune‐related adverse event; nivolumab; programmed death receptor‐1.
© 2022 The Authors. Health Science Reports published by Wiley Periodicals LLC.