Third Department of Internal Medicine, University of Toyama, Toyama, Japan;
Department of Medical Oncology, Toyama Red Cross Hospital, Toyama, Japan.
In Vivo. 2021 Jan-Feb;35(1):475-482. doi: 10.21873/invivo.12281.
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 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.
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).
The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC.
免疫检查点抑制剂（ICI），包括纳武利尤单抗和帕博利珠单抗，是治疗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（irAEs）的频率以及 irAEs 与其在 AGC 病例中的疗效之间的相关性。
根据 irAE 的发生情况将患者分为两组。评估 irAEs 的频率以及治疗结果（缓解率[RR]、无进展生存期[PFS]和总生存期[OS]）。考虑到领先时间偏倚，通过 landmark 分析评估生存率。
在接受纳武利尤单抗或帕博利珠单抗治疗的 108 例患者中，有 17 例（15.7%）发生了 irAEs。在 4 周 landmark 分析中，有 irAEs 的患者的 RR、中位 PFS 和中位 OS 分别为 28.5%、3.9 个月（95%CI=2.8-9.3）和 12.2 个月（95%CI=3.8-NA），而无 irAEs 的患者的 RR、中位 PFS 和中位 OS 分别为 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）。多变量分析显示，irAEs 与 PFS 改善相关（HR=2.08，95%CI=1.34-3.21）。
irAEs 的发生与 AGC 患者接受 ICI 治疗的临床结局改善相关。
