Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China; Fujian Province Minimally Invasive Medical Center, Fuzhou, China.
Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China; Fujian Province Minimally Invasive Medical Center, Fuzhou, China.
Eur J Surg Oncol. 2023 Oct;49(10):107007. doi: 10.1016/j.ejso.2023.107007. Epub 2023 Aug 9.
The number of randomized controlled trials (RCTs) investigating the systemic treatment of gastric or gastroesophageal junction adenocarcinoma (GA-RCTs) is increasing. We aimed to describe the characteristics and evaluate the clinical benefit of GA-RCTs over the past 20 years.
We searched for RCTs of systemic treatment in GA published in eight major journals between 2001 and 2020 in PubMed. From the included studies, the characteristics and results of GA-RCTs were extracted. Clinical benefit was assessed using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
About 93 RCTs with 38365 patients were included. Seventy-one (76.3%) studies received external funding, with an increase from 27.3% (2001-2005) to 94.1% (2016-2020). RCTs on targeted therapy and/or immunotherapy have also increased over time, but only 14 (41.2%) were restricted to specific biomarkers. Forty-four (47.3%) studies met their primary endpoint (defined as positive RCTs), but median overall survival has not improved over time. Moreover, only 16 (36.4%) studies met the ESMO-MCBS threshold. RCTs whose study design and results met the ESMO-MCBS thresholds has not increased over time (p = 0.827 and p = 0.733, respectively).
GA-RCTs are increasingly focused on targeted therapy and/or immunotherapy, and are more likely to receive external funding. However, the effect size has not shown significant improvement in the past 20 years. Only a few RCTs with positive results met ESMO thresholds. Future RCTs should prioritize the clinical benefits and provide direct evidence to optimize and reform GA treatment practices.
针对胃或胃食管结合部腺癌（GA）的系统治疗的随机对照试验（RCT）数量正在增加。我们旨在描述过去 20 年来 GA-RCT 的特征并评估其临床获益。
我们在 PubMed 中检索了 2001 年至 2020 年间发表于八大期刊的 GA 系统治疗 RCT。从纳入的研究中，提取了 GA-RCT 的特征和结果。使用欧洲肿瘤内科学会临床获益量表（ESMO-MCBS）评估临床获益。
共纳入了约 93 项包含 38365 例患者的 RCT。71 项（76.3%）研究获得了外部资助，这一比例从 2001-2005 年的 27.3%上升至 2016-2020 年的 94.1%。靶向治疗和/或免疫治疗的 RCT 也在增加，但仅有 14 项（41.2%）仅限于特定的生物标志物。44 项（47.3%）研究达到了主要终点（定义为阳性 RCT），但中位总生存期并未随时间改善。此外，仅有 16 项（36.4%）研究达到了 ESMO-MCBS 标准。符合 ESMO-MCBS 标准的 RCT 数量并未随时间增加（p=0.827 和 p=0.733）。
GA-RCT 越来越关注靶向治疗和/或免疫治疗，并且更有可能获得外部资助。然而，过去 20 年来，疗效大小并未显示出显著改善。仅有少数阳性结果的 RCT 达到了 ESMO 标准。未来的 RCT 应优先考虑临床获益，并提供直接证据以优化和改革 GA 治疗实践。
