Objective: In this study, we aimed to investigate the short-term efficacy and safety of perioperative administration of the PD-1 inhibitor tislelizumab combined with the SOX regimen (oxaliplatin plus S-1) in patients with locally advanced gastric cancer, and to identify factors influencing therapeutic outcomes. Methods: In this retrospective cohort study, we analyzed clinical data of 166 patients who had undergone perioperative therapy and D2 radical gastrectomy in the Department of General Surgery, First Medical Center of Chinese PLA General Hospital between September 2021 and September 2023. The cohort comprised 140 men and 26 women, of median age 62 years (range: 30-75). The patients were allocated to two groups: 62 receiving tislelizumab plus SOX (combination therapy group), and 104 SOX alone (chemotherapy-only group). Primary outcomes included pathological complete response rate, treatment-related adverse events, and complications of surgery. Secondary outcomes comprised major pathological response rate, tumor regression grade (Grades 1-2 denoting favorable response, Grade 3 moderate, and Grades 4-5 poor response), R0 resection rate, and short-term survival outcomes (1-year disease-free and overall survivals). Risk factors associated with pCR in the combination group were also analyzed. Results: The combination therapy group exhibited significantly higher rates of pCR (25.8% vs. 8.7%, χ2=8.93, P=0.003) and Grade 1 tumor regression (25.8% vs. 16.3%, χ2=15.32, P=0.001) than the chemotherapy-only group. There were no statistically significant differences in major pathological response rates (41.9% vs. 39.4%), R0 resection rates (96.8% vs. 97.1%,), treatment- related adverse events (48.4% vs. 42.3%,), surgical complications (9.7% vs. 12.5%), 1-year disease-free survival (82.3% vs. 78.8%), or 1-year overall survival (93.5% vs. 91.3%), There were no statistically significant differences (all P>0.05). Multivariate logistic analysis identified neural invasion as an independent risk factor for reduced pCR in the combination group (OR=0.10, 95%CI:0.01-0.85,P=0.035). Conclusions: Perioperative tislelizumab combined with SOX chemotherapy improves pathological response rates in patients with locally advanced gastric cancer and has favorable short-term efficacy and safety profiles. Neural invasion may diminish the therapeutic efficacy of immunotherapy.
目的: 探讨局部进展期胃癌患者围手术期应用PD-1抑制剂替雷利珠单抗联合SOX方案(奥沙利铂+替吉奥)治疗的近期疗效及安全性,并探讨影响疗效的因素。 方法: 采用回顾性队列研究的方法。收集2021年9月至2023年9月期间,在解放军总医院第一医学中心普通外科医学部接受围手术期治疗并行D2根治性胃切除术的166例患者临床资料,其中男140例,女26例,中位年龄为62(30~75)岁;62例接受替雷利珠单抗联合SOX治疗(联合治疗组),104例单纯接受SOX方案化疗(单纯化疗组),对两组患者的近期疗效进行比较。主要观察指标为病理完全缓解(pCR)率、围手术期治疗相关不良事件(TRAE)和手术并发症发生情况;次要观察指标为主要病理缓解率(MPR)、肿瘤退缩分级(TRG,1~2级为疗效较好,3级为疗效一般,4~5级为疗效差)、肿瘤R0切除率和短期生存结局[1年无病生存率(DFS)和总体生存率(OS)];分析影响联合治疗组患者pCR的危险因素。 结果: 联合治疗组与单纯化疗组比较,pCR率[25.8%(16/62)比8.7%(9/104),χ2=8.93,P=0.003]和TRG 1级占比[25.8%(16/62)比16.3%(17/104),χ2=15.32,P=0.001]均显著增高,而两组患者的MPR率[41.9%(26/62)比39.4%(41/104)]、R0切除率(96.8%(60/62)比97.1%(101/104)]、围手术期TRAE发生率[48.4%(30/62)比42.3%(44/104)]、手术相关并发症发生率[9.7%(6/62)比12.5%(13/104)]、1年DFS(82.3%比78.8%)和1年OS(93.5%比91.3%)差异均无统计学意义(均P>0.05)。多因素logistic分析结果显示,神经浸润是影响联合治疗组pCR率的独立危险因素(OR=0.10,95%CI:0.01~0.85,P=0.035)。 结论: 围手术期应用替雷利珠单抗联合SOX方案化疗可提高局部进展期胃癌患者的肿瘤病理应答率,近期疗效及安全性良好;神经浸润可能削弱免疫治疗的效果。.