Department of oncology, Changzhou Hospital of Traditional Chinese Medicine, Changzhou, China.
Department of Pharmacy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241273286. doi: 10.1177/15330338241273286.
Immune checkpoint inhibitor (ICI) plus chemotherapy is effective in advanced gastric or gastroesophageal junction (G/GEJ) cancer. This study aims to evaluate the clinical effect of first-line immunotherapy in combination with chemotherapy for advanced G/GEJ cancer PubMed, Web of Science, Embase and Cochrane databases were systematically searched from the inception of the databases to December 2021. Randomized trials comparing ICI plus chemotherapy with chemotherapy in first-line treatment for advanced G/GEJ cancer were included. The outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Analyses were performed in Stata 14.0 software. The study protocol was registered with PROSPERO, number CRD42022300907. Five trials were included for analysis, involving 2, 814 patients. ICI plus chemotherapy can significantly improve OS (hazards ratio [HR], 0.86; 95% CI 0.78-0.94; = .002), PFS (HR, 0.79; 95% CI 0.63-0.99; ＜ .001) and ORR (relative ratio [RR], 1.20; 95% CI 1.11-1.30; < .001). In safety analyses, there were no significant differences in incidence of all AEs, treatment-related adverse event (TRAE), TRAE of grade 3 or higher, serious TRAE and TRAE leading to death between two arms ( > .05). ICI plus chemotherapy is more effective first-line treatment for advanced G/GEJ cancer in contrast to chemotherapy regrading to improving OS, PFS and ORR, without increasing TRAE risk. This study will redefine the role of ICI in combination with chemotherapy in the first-line setting for G/GEJ cancer, and provide reference for clinical treatment.
免疫检查点抑制剂（ICI）联合化疗在晚期胃或胃食管结合部（G/GEJ）癌中有效。本研究旨在评估一线免疫治疗联合化疗治疗晚期 G/GEJ 癌的临床效果。我们系统地检索了 PubMed、Web of Science、Embase 和 Cochrane 数据库，检索时间从数据库建立到 2021 年 12 月。纳入比较 ICI 联合化疗与化疗作为晚期 G/GEJ 癌一线治疗的随机试验。主要结局为总生存（OS）、无进展生存（PFS）、客观缓解率（ORR）和不良事件（AEs）。采用 Stata 14.0 软件进行分析。研究方案已在 PROSPERO 注册，编号为 CRD42022300907。纳入 5 项研究进行分析，共 2814 例患者。ICI 联合化疗可显著改善 OS（风险比 [HR]，0.86；95%CI，0.78-0.94； = .002）、PFS（HR，0.79；95%CI，0.63-0.99； < .001）和 ORR（相对比 [RR]，1.20；95%CI，1.11-1.30； < .001）。安全性分析结果显示，两组患者的所有 AEs、治疗相关不良事件（TRAE）、3 级及以上 TRAE、严重 TRAE 和导致死亡的 TRAE 发生率差异均无统计学意义（ > .05）。与化疗相比，ICI 联合化疗作为晚期 G/GEJ 癌的一线治疗更为有效，可改善 OS、PFS 和 ORR，且不增加 TRAE 风险。本研究将重新定义 ICI 联合化疗在 G/GEJ 癌一线治疗中的作用，为临床治疗提供参考。
