Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Jiangsu Collaborative Innovation Center for Cancer Personalized Medical University, Nanjing, China.
Front Immunol. 2023 Jun 23;14:1193614. doi: 10.3389/fimmu.2023.1193614. eCollection 2023.
Recently, 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.
Herein, 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).
Five 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.
nICT 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.
最近，免疫化疗在治疗晚期胃癌（GC）中的应用越来越多，程序性死亡蛋白 1（PD-1）抑制剂联合化疗已成为晚期 GC 的一线治疗方法。然而，很少有小样本量的研究检查这种治疗方案，以评估其在可切除局部晚期 GC 的新辅助治疗阶段的有效性和安全性。
本文系统地检索了 PubMed、Cochrane CENTRAL 和 Web of Science 中关于晚期 GC 新辅助免疫化疗（nICT）的临床试验。主要结局是有效性[通过主要病理缓解（MPR）和病理完全缓解（pCR）评估]和安全性[通过 3-4 级治疗相关不良事件（TRAEs）和术后并发症评估]。对非比较二项结果进行荟萃分析，以汇总主要结局。直接比较分析用于比较新辅助化疗（nCT）与 nICT 的汇总结果。结果以风险比（RR）表示。
纳入了 5 篇来自中国人群的文章，共 206 例患者。pCR 和 MPR 的汇总率分别为 26.5%（95%CI：21.3%-33.3%）和 49.0%（95%CI：42.3%-55.9%），3-4 级 TRAEs 和术后并发症发生率分别为 20.0%（95%CI：9.1%-39.8%）和 30.1%（95%CI：23.1%-37.9%）。直接比较显示，除了 3-4 级 TRAEs 和术后并发症外，所有结局包括 pCR、MPR 和 R0 切除率均有利于 nICT 优于 nCT。
nICT 是治疗中国晚期 GC 患者的一种很有前途的策略。然而，需要更多的 III 期随机对照试验（RCT）来进一步巩固这种方案的疗效和安全性。
