Leng Jun, Liu Min, Wang Qianwen, Jiang Huaiwu, Chen Jin
North Sichuan Medical College, Nanchong, Sichuan, China.
Department of General Surgery, Mian Yang 404 Hospital, Mianyang, Sichuan, China.
Front Med (Lausanne). 2025 Aug 5;12:1625259. doi: 10.3389/fmed.2025.1625259. eCollection 2025.
Neoadjuvant chemotherapy, particularly neoadjuvant immunotherapy, has achieved significant progress in treating gastric cancer (GC) and gastroesophageal junction (GEJ) adenocarcinoma. While PD-1/PD-L1 inhibitors have improved survival outcomes in some patients, the efficacy of combining neoadjuvant chemotherapy with PD-1/PD-L1 inhibitors remains insufficiently validated.
This study aims to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with PD-1/PD-L1 inhibitors in GC/GEJ adenocarcinoma and enhance statistical power through meta-analysis.
We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library up to October 5, 2024, for original clinical studies on neoadjuvant PD-1/PD-L1 inhibitors combined with chemotherapy for GC/GEJ adenocarcinoma. Eligible studies were evaluated using the Methodological Index for Non-Randomized Studies (MINORS) Criteria. Meta-analysis was performed using R 4.4.2 software.
A total of 12 studies involving 428 patients were included. The primary efficacy outcomes were pathological complete response (pCR) and major pathological response (MPR), while secondary outcomes included disease control rate (DCR) and the rate of lymph node downstaging to ypN0. The effect size (ES) for pCR was 20.94% [95% CI: 0.1698; 0.2518], and for MPR, the ES was 55.86% [95% CI: 0.4891; 0.6271]. Safety was evaluated using the incidence of grade ≥3 treatment-related adverse events (trAEs), immune-related adverse events (irAEs), postoperative complications, and R0 resection rate. The meta-analysis revealed that 406 patients underwent surgical intervention, with 88 achieving pCR. The pooled effect size for R0 resection rate was 95.2% [95% CI: 0.896; 0.989]. The ES values for grade ≥3 adverse events, immune-related adverse events, and postoperative complications were 0.54 [95% CI: 0.30; 0.77], 0.17 [95% CI: 0.07; 0.31], and 0.28 [95% CI: 0.15; 0.44], respectively.
Neoadjuvant PD-1/PD-L1 inhibitor-based chemotherapy demonstrates promising therapeutic efficacy and safety in patients with gastric and gastroesophageal junction (GEJ) cancer. However, limitations such as small sample sizes and insufficient follow-up duration in current studies highlight the need for further randomized controlled trials and multicenter research to establish optimal treatment strategies.
Identifier, CRD42024619916.
新辅助化疗，尤其是新辅助免疫治疗，在治疗胃癌（GC）和胃食管交界（GEJ）腺癌方面取得了显著进展。虽然PD-1/PD-L1抑制剂改善了部分患者的生存结局，但新辅助化疗联合PD-1/PD-L1抑制剂的疗效仍未得到充分验证。
本研究旨在评估新辅助化疗联合PD-1/PD-L1抑制剂治疗GC/GEJ腺癌的疗效和安全性，并通过荟萃分析提高统计效能。
我们系统检索了截至2024年10月5日的PubMed、Embase、Web of Science和Cochrane图书馆，以查找关于新辅助PD-1/PD-L1抑制剂联合化疗治疗GC/GEJ腺癌的原始临床研究。使用非随机研究方法学指数（MINORS）标准对符合条件的研究进行评估。使用R 4.4.2软件进行荟萃分析。
共纳入12项研究，涉及428例患者。主要疗效指标为病理完全缓解（pCR）和主要病理缓解（MPR），次要指标包括疾病控制率（DCR）和淋巴结降期至ypN0的比例。pCR的效应量（ES）为20.94%[95%CI：0.1698；0.2518]，MPR的ES为55.86%[95%CI：0.4891；0.6271]。使用≥3级治疗相关不良事件（trAE）、免疫相关不良事件（irAE）、术后并发症的发生率和R0切除率评估安全性。荟萃分析显示，406例患者接受了手术干预，88例达到pCR。R0切除率的合并效应量为95.2%[95%CI：0.896；0.989]。≥3级不良事件、免疫相关不良事件和术后并发症的ES值分别为0.54[95%CI：0.30；0.77]、0.17[95%CI：0.07；0.31]和0.28[95%CI：0.15；0.44]。
基于新辅助PD-1/PD-L1抑制剂的化疗在胃癌和胃食管交界（GEJ）癌患者中显示出有前景的治疗疗效和安全性。然而，当前研究存在样本量小和随访时间不足等局限性，凸显了进一步开展随机对照试验和多中心研究以建立最佳治疗策略 的必要性。
标识符，CRD42024619916。
