本研究对 2018 年 4 月至 2022 年 3 月在日本埼玉癌症中心从参比曲妥珠单抗转用其生物仿制药曲妥珠单抗-NK 的胃癌患者的输注反应 (IR) 进行了安全性分析。如果患者出现症状，就会发现 IR。服用当天或次日出现发热、寒战、输注相关反应、过敏、皮疹、瘙痒、荨麻疹、全身性疾病或免疫系统疾病等。参考曲妥珠单抗组的 IR 发生率为 14%，曲妥珠单抗-NK 组为 33%，转换组为 33%。参考曲妥珠单抗组和曲妥珠单抗-NK 组之间的 IR 发生率没有显着差异 (p = 0.235)。在转换组中，经历过 IR 的三名患者中只有一名出现与转换相关的反应。这些发现表明，转换组胃癌中 IR 的频率与其他组相当，表明转换是经过适当管理的可行治疗选择。此外，该研究中的 45 名患者中有 37 名是男性，这提供了此前未曾报道过的关于男性患者转为胃癌的新安全信息。

This study presents a safety analysis of infusion reactions (IRs) in gastric cancer patients who switched from reference trastuzumab to its biosimilar, trastuzumab-NK, at the Saitama Cancer Center in Japan from April 2018 to March 2022. IRs were identified if patients developed symptoms such as fever, chills, infusion-related reactions, hypersensitivity, rash, pruritus, urticaria, systemic disorders, or immune system disorders on the day of administration or the following day. The incidence of IRs was 14% in the reference trastuzumab group, 33% in the trastuzumab-NK group, and 33% in the switching group. There was no significant difference in IR incidence between the reference trastuzumab and trastuzumab-NK groups (p = 0.235). Among the switching group, only one of the three patients who experienced an IR had a reaction associated with the switch. These findings suggest that the frequency of IRs in the switching group gastric cancer is comparable to the other groups, indicating that switching is a viable treatment option with appropriate management. Additionally, 37 of the 45 patients in the study were male, provides new safety information on switching in gastric cancer for male patients that has not been previously reported.