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...

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Detalles Bibliográficos
Autores principales: Iikura, Yusuke, Aoyama, Takeshi, Hiraide, Makoto, Wakatsuki, Takeru, Nakayama, Izuma, Ogura, Mariko, Ooki, Akira, Takahari, Daisuke, Chin, Keisho, Yamaguchi, Kensei, Hama, Toshihiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9165198/
https://www.ncbi.nlm.nih.gov/pubmed/35662976
http://dx.doi.org/10.1002/hsr2.673
Descripción
Sumario: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.

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