Background: Immune-checkpoint inhibitors (ICI), including nivolumab and pembrolizumab, are among the standard treatments for previously treated advanced gastric cancer (AGC). This study aimed to evaluate the frequency of immune-related adverse events (irAEs) and the correlation between irAEs and their efficacy in AGC cases. Patients and Methods: Patients were divided into two groups according to irAE occurrence. The frequency of irAEs and the treatment outcome (response rate [RR], progression-free survival [PFS], and overall survival [OS]) were evaluated. The survival rates were evaluated by landmark analysis considering lead-time bias. Results: Among 108 patients who received nivolumab or pembrolizumab, 17 (15.7%) had irAEs. In a 4-week landmark analysis, the RR, median PFS, and median OS were 28.5%, 3.9 months (95% CI=2.8-9.3), and 12.2 months (95% CI=3.8-NA) in patients with irAEs, while 3.0% (2/65), 1.8 months (95% CI=1.4-2.1), and 3.5 months (95% CI, 2.9-5.1) in patients without irAEs, respectively. In multivariate analysis, irAEs were associated with better PFS (HR=2.08, 95% CI=1.34-3.21). Conclusion: The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC.

中文翻译：

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接受纳武单抗或派姆单抗治疗的晚期胃癌患者免疫相关不良事件的预后：一项多中心回顾性分析

背景：免疫检查点抑制剂 (ICI)，包括纳武单抗和派姆单抗，是既往治疗过的晚期胃癌 (AGC) 的标准治疗方法之一。本研究旨在评估免疫相关不良事件 (irAE) 的频率以及 irAE 与其在 AGC 病例中的疗效之间的相关性。患者和方法：根据irAE的发生将患者分为两组。评估了 irAE 的频率和治疗结果（反应率 [RR]、无进展生存期 [PFS] 和总生存期 [OS]）。考虑到提前期偏差，通过标志性分析评估存活率。结果：在接受纳武单抗或派姆单抗治疗的 108 名患者中，17 名 (15.7%) 出现 irAE。在为期 4 周的标志性分析中，RR、中位 PFS 和中位 OS 分别为 28.5%、3.9 个月（95% CI=2.8-9.3）和 12 个月。irAE 患者为 2 个月（95% CI=3.8-NA），而 irAE 患者为 3.0%（2/65）、1.8 个月（95% CI=1.4-2.1）和 3.5 个月（95% CI，2.9-5.1）分别为没有 irAE 的患者。在多变量分析中，irAE 与更好的 PFS 相关（HR=2.08，95% CI=1.34-3.21）。结论： irAEs 的发生与 AGC 患者 ICIs 更好的临床结果相关。