Pan Xuan, Zhu Huayun, Li Xingwang, Liu Siwen, Dong Shuchen, Yue Chao, Wu Pingping, Sun Yan
Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, Jiangsu, China.
Department of General Surgery, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, Jiangsu, China.
Cancer Immunol Immunother. 2025 Sep 18;74(10):311. doi: 10.1007/s00262-025-04153-6.
Immunotherapy has brought clinical benefits for patients with advanced or late-stage gastric cancer. This real-world study aimed to evaluate the efficacy and safety of neoadjuvant immunochemotherapy in patients with locally advanced gastric cancer (LAGC).
Patients with LAGC (cT2-4bN1-3M0) were enrolled in this retrospective study. Patients received either neoadjuvant immunochemotherapy or chemotherapy alone before surgery. The primary endpoint was the pathological complete response (pCR) rate.
A total of 111 patients were included in this study, with 49 received neoadjuvant PD-1 inhibitors combined with chemotherapy (Group A) and 62 received chemotherapy alone (Group B). pCR rate of Group A was significantly higher than that of Group B (22.4% vs. 4.8%, P = 0.011). Compared with the clinical TNM stage before neoadjuvant therapy, 32 (65.3%) patients in Group A had T downstaging, 27 (55.1%) had N downstaging, and 42 (85.7%) had overall TNM downstaging. There was no significant difference in 1-year OS rate (100% vs. 93.5%; P = 0.195) and 1-year DFS rate (81.6% vs. 75.8%; P = 0.144) between the two groups. 11.7% patients in Group A and 9.8% patients in Group B experienced grade ≥ 3 adverse TRAEs, myelosuppression, elevated ALT/AST, nausea, and decreased appetite. However, there was no significant difference between the two groups (P = 0.240).
Here, neoadjuvant immunochemotherapy suggested a potential clinical benefit of the pCR rate, T downstaging, and a favorable safety profile for LAGC. However, further multicenter, large-scale randomized clinical trials are urgently needed to confirm the long-term survival benefit.
免疫疗法已为晚期胃癌患者带来临床益处。这项真实世界研究旨在评估新辅助免疫化疗在局部晚期胃癌（LAGC）患者中的疗效和安全性。
LAGC（cT2 - 4bN1 - 3M0）患者纳入这项回顾性研究。患者在手术前接受新辅助免疫化疗或单纯化疗。主要终点是病理完全缓解（pCR）率。
本研究共纳入111例患者，其中49例接受新辅助PD - 1抑制剂联合化疗（A组），62例接受单纯化疗（B组）。A组的pCR率显著高于B组（22.4%对4.8%，P = 0.011）。与新辅助治疗前的临床TNM分期相比，A组32例（65.3%）患者T分期降低，27例（55.1%）患者N分期降低，42例（85.7%）患者总体TNM分期降低。两组的1年总生存率（100%对93.5%；P = 0.195）和1年无病生存率（81.6%对75.8%；P = 0.144）无显著差异。A组11.7%的患者和B组9.8%的患者发生≥3级不良治疗相关不良反应，包括骨髓抑制、ALT/AST升高、恶心和食欲下降。然而，两组之间无显著差异（P = 0.240）。
在此，新辅助免疫化疗对LAGC显示出pCR率、T分期降低方面的潜在临床益处以及良好的安全性。然而，迫切需要进一步的多中心、大规模随机临床试验来证实长期生存获益。
