PDF(Pubmed)
Abstract：
Background: 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. Methods: 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. Results: 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; P = .002), PFS (HR, 0.79; 95% CI 0.63-0.99; P ＜ .001) and ORR (relative ratio [RR], 1.20; 95% CI 1.11-1.30; P < .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 (P > .05). Conclusions: 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.
摘要：
背景：免疫检查点抑制剂（ICI）加化疗对晚期胃癌或胃食管交界癌（G/GEJ）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。方法:PubMed,WebofScience,从数据库成立到2021年12月，对Embase和Cochrane数据库进行了系统搜索。纳入比较ICI加化疗与化疗一线治疗晚期G/GEJ癌的随机试验。结果是总生存期（OS），无进展生存期（PFS），客观反应率（ORR），和不良事件（AE）。在Stata14.0软件中进行分析。研究方案在PROSPERO注册，编号CRD42022300907。结果：纳入5项试验进行分析，涉及2,814名患者。ICI加化疗可以显著提高OS(危险比[HR]，0.86；95%CI0.78-0.94；P=.002），PFS(HR,0.79；95%CI0.63-0.99；P＜.001）和ORR（相对比率[RR]，1.20；95%CI1.11-1.30；P<.001）。在安全分析中，所有不良事件的发生率没有显着差异，治疗相关不良事件（TRAE），3级或更高的TRAE，严重的TRAE和TRAE导致两臂之间死亡(P>.05)。结论：ICI联合化疗对晚期G/GEJ癌的一线治疗比化疗改善OS更为有效。PFS和ORR,不增加TRAE风险。这项研究将重新定义ICI联合化疗在G/GEJ癌症一线治疗中的作用。为临床治疗提供参考。
