Iikura Yusuke, Aoyama Takeshi, Hiraide Makoto, Wakatsuki Takeru, Nakayama Izuma, Ogura Mariko, Ooki Akira, Takahari Daisuke, Chin Keisho, Yamaguchi Kensei, Hama Toshihiro
Department of Pharmacy Cancer Institute Hospital, Japanese Foundation for Cancer Research Koto City Tokyo Japan.
Division of Applied Pharmaceutical Education and Research Hoshi University Shinagawa-Ku Tokyo Japan.
Health Sci Rep. 2022 Jun 3;5(4):e673. doi: 10.1002/hsr2.673. eCollection 2022 Jul.
This study aimed to examine the safety of fixed-dose nivolumab.
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).
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.
This is the first report on the safety of nivolumab at 240 mg in Japanese patients.
本研究旨在检验固定剂量纳武利尤单抗的安全性。
我们回顾性分析了113例先前接受过细胞毒性化疗并开始使用纳武利尤单抗治疗的日本胃癌患者的病历。终点指标为常规剂量（3mg/kg）组和固定剂量组（240mg）中2级或更高等级免疫相关不良事件（irAE）的发生率。
常规剂量组和固定剂量组irAE的发生率分别为29.9%和19.4%，2级或更高等级irAE的发生率分别为23.3%和19.4%，两组之间无显著差异，这表明240mg的纳武利尤单抗与3mg/kg剂量一样安全。
这是关于240mg纳武利尤单抗在日本患者中安全性的首份报告。
