Table_1_Evaluation of neoadjuvant immunotherapy plus chemotherapy in Chinese surgically resectable gastric cancer: a pilot study by meta-analysis.docx

BackgroundRecently, the use of immunochemotherapy in the treatment of advanced gastric cancer (GC) has been increasing and programmed cell death protein 1 (PD-1) inhibitors combined with chemotherapy has become the first-line treatment for advanced GC. However, few studies with small sample sizes have examined this treatment regimen to assess its effectiveness and safety in the neoadjuvant treatment phase of resectable local advanced GC.
Materials and methodsHerein, we systematically searched PubMed, Cochrane CENTRAL, and Web of Science for clinical trials on neoadjuvant immunochemotherapy (nICT) in advanced GC. The primary outcomes were effectiveness [evaluated by major pathological response (MPR) and pathological complete response (pCR)] and safety [assessed by grade 3–4 treatment-related adverse events (TRAEs) and postoperative complications]. A meta-analysis of non-comparative binary results was performed to aggregate the primary outcomes. Direct comparative analysis was used to compare pooled results of neoadjuvant chemotherapy (nCT) with nICT. The outcomes emerged as risk ratios (RR).
ResultsFive articles with 206 patients were included, and all of them were from the Chinese population. The pooled pCR and MPR rates were 26.5% (95% CI: 21.3%–33.3%) and 49.0% (95% CI: 42.3%–55.9%), while grade 3–4 TRAEs and post-operative complication rates were 20.0% (95% CI: 9.1%–39.8%) and 30.1% (95% CI: 23.1%–37.9%), respectively. Direct comparison showed that with the exception of grade 3–4 TRAEs and postoperative complications, all outcomes including pCR, MPR, and R0 resection rate favoured nICT to nCT.
ConclusionnICT is a promising strategy for use as an advisable neoadjuvant treatment for patients with advanced GC in Chinese population. However, more phase III randomized controlled trials (RCTs) will be required to further consolidate the efficacy and safety of this regimen.

研究背景
近年来，免疫化疗在晚期胃癌（gastric cancer, GC）治疗中的应用日益增多，程序性细胞死亡蛋白1（programmed cell death protein 1, PD-1）抑制剂联合化疗已成为晚期胃癌的一线治疗方案。然而，目前仅有少量小样本量的研究针对该治疗方案在可切除局部晚期胃癌新辅助治疗阶段的有效性与安全性进行评估。
材料与方法
本研究系统检索了PubMed、Cochrane CENTRAL及Web of Science数据库中关于晚期胃癌新辅助免疫化疗（neoadjuvant immunochemotherapy, nICT）的临床试验。主要结局指标包括有效性[以主要病理缓解（major pathological response, MPR）及病理完全缓解（pathological complete response, pCR）进行评估]与安全性[以3~4级治疗相关不良事件（treatment-related adverse events, TRAEs）及术后并发症进行评估]。采用非比较二分类结果的Meta分析汇总主要结局指标；采用直接比较分析法对比新辅助化疗（neoadjuvant chemotherapy, nCT）与nICT的合并结果，结局指标以风险比（risk ratio, RR）表示。
结果
最终纳入5项研究，共206例患者，且所有研究均来自中国人群。合并后的pCR率为26.5%（95%CI：21.3%~33.3%），MPR率为49.0%（95%CI：42.3%~55.9%）；3~4级TRAE发生率为20.0%（95%CI：9.1%~39.8%），术后并发症发生率为30.1%（95%CI：23.1%~37.9%）。直接对比结果显示，除3~4级TRAE及术后并发症外，nICT在pCR、MPR及R0切除率等所有结局指标上均优于nCT。
结论
对于中国人群的局部晚期胃癌患者，nICT是一种极具应用前景的理想新辅助治疗方案。但仍需开展更多Ⅲ期随机对照试验（randomized controlled trials, RCTs）以进一步巩固该治疗方案的有效性与安全性。