Wan Linghong, Tian Fanxuan, Wang Lei, Hou Yongying, Liu Wenkang, Liu Qin, Chen Dongfeng, Li Xianfeng, Xiang Junyv, Qin Zhong-Yi, Wang Tao, Mao Bijng, Wu Linyu, Hu Lu
Department of Gastroenterology and Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), 10 Changjiang Branch Road, Yuzhong District, Chongqing, 400042, P. R. China.
Department of Pathology, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China.
Cell Oncol (Dordr). 2024 Dec;47(6):2335-2347. doi: 10.1007/s13402-024-01021-w. Epub 2024 Dec 5.
Neoadjuvant immunochemotherapy is emerging as a promising regimen for patients with locally advanced gastric and gastroesophageal junction (G/GEJ) adenocarcinoma. However, it remains unclear whether immunochemotherapy will bring more adverse events (AEs) leading to a delay or even cancellation of surgeries. We aimed to provide a comprehensive analysis of the toxicity profiles for immune checkpoint inhibitors (ICIs) combined with chemotherapy among patients with G/GEJ adenocarcinoma.
Published trials up to January 2024 were identified on Web of Science, Cochrane Library, Embase, and PubMed. Single-group and controlled clinical trials with ICIs in combination with chemotherapy in patients with G/GEJ adenocarcinoma were included. Two reviewers independently extracted data including incidence rate of AEs. The primary outcomes included the proportion of patients with adverse events leading to treatment discontinuation, grade 3 or higher adverse events, and serious adverse events. This study is registered with PROSPERO (CRD42023492676).
Twenty studies were included for a total of 6692 patients. In patients receiving immunochemotherapy, 17% (95% confidence interval (CI), 11-23%) had adverse events leading to treatment discontinuation, 23% (95% CI, 19-27%) had serious adverse events, and 64% (95% CI, 58-70%) had grade 3 or higher adverse events. Compared with patients receiving chemotherapy alone, patients with immunochemotherapy were associated with higher rates of adverse events leading to discontinuation (RR, 1.45; 95% CI, 1.32-1.60), serious adverse events (RR, 1.27; 95% CI, 1.04-1.57), and grade 3 or higher adverse events (RR, 1.15; 95% CI, 1.07-1.23).
In conclusion, the incidence of adverse events leading to discontinuation, serious adverse events, and grade 3 or higher adverse events were higher in patients receiving immunochemotherapy compared to those with chemotherapy.
新辅助免疫化疗正成为局部晚期胃癌和胃食管交界部（G/GEJ）腺癌患者一种有前景的治疗方案。然而，免疫化疗是否会带来更多不良事件（AE）导致手术延迟甚至取消仍不清楚。我们旨在全面分析免疫检查点抑制剂（ICI）联合化疗在G/GEJ腺癌患者中的毒性特征。
在Web of Science、Cochrane图书馆、Embase和PubMed上检索截至2024年1月发表的试验。纳入G/GEJ腺癌患者中ICI联合化疗的单组和对照临床试验。两名研究者独立提取包括不良事件发生率的数据。主要结局包括导致治疗中断的不良事件患者比例、3级或更高等级不良事件以及严重不良事件。本研究已在PROSPERO注册（CRD42023492676）。
纳入20项研究，共6692例患者。接受免疫化疗的患者中，17%（95%置信区间（CI），11 - 23%）发生导致治疗中断的不良事件，23%（95%CI，19 - 27%）发生严重不良事件，64%（95%CI，58 - 70%）发生3级或更高等级不良事件。与单纯接受化疗的患者相比，接受免疫化疗的患者发生导致治疗中断的不良事件（RR，1.45；95%CI，1.32 - 1.60）、严重不良事件（RR，1.27；95%CI，1.04 - 1.57）和3级或更高等级不良事件（RR，1.15；95%CI，1.07 - 1.23）的发生率更高。
总之，与化疗患者相比，接受免疫化疗的患者发生导致治疗中断的不良事件、严重不良事件以及3级或更高等级不良事件的发生率更高。
