中国实用外科杂志

中国实用外科杂志 ›› 2025, Vol. 45 ›› Issue (07): 788-793.DOI: 10.19538/j.cjps.issn1005-2208.2025.07.12

• 论著 • 上一篇    下一篇

基于国内多中心真实世界数据的局部进展期胃癌新辅助治疗现状及疗效分析

张    鹏1，林建贤2，杜雨强1，王鑫鑫3，李    伟4，盛伟伟5，唐兆庆6，袁庶强7，王林俊8，曹    毅9，陶    凯10，王大广4，孙    晶11，邢加迪12，张子臻13，史    征14，尹 杰15，王    震16，曹守根17，刘鑫璐18，商    亮19，肖    华20，黄昌明2，孙益红6，练    磊21，赵玉洲22，陶凯雄1   

  1.  1华中科技大学同济医学院附属协和医院胃肠外科，湖北武汉 430022；2福建医科大学附属协和医院胃外科，福建福州 350001；3中国人民解放军总医院第一医学中心普通外科医学部，北京 100853；4吉林大学第一医院普通外科中心胃结直肠外科，吉林长春 130021；5安徽医科大学第一附属医院胃肠外科一病区，安徽合肥 230022 ；6复旦大学附属中山医院普外科，上海 200032；7中山大学肿瘤防治中心胃外科，广东广州 510060；8南京医科大学第一附属医院（江苏省人民医院）胃外科，江苏南京 210029；9南昌大学第一附属医院普外科，江西南昌 330006；10中国医学科学院肿瘤医院山西医院（山西省肿瘤医院）肝胆胰胃外科，山西太原 030013；11上海交通大学医学院附属瑞金医院普外科，上海 200025；12北京大学肿瘤医院胃肠肿瘤中心，北京 100142；13上海交通大学医学院附属仁济医院胃肠外科，上海 200127；14海军军医大学第一附属医院胃肠外科，上海 20043；15首都医科大学附属北京友谊医院普外科，北京 100050；16广西医科大学第一附属医院胃肠腺体外科，广西南宁 530021；17青岛大学附属医院普外科，山东青岛 266002；18大连医科大学附属第一医院普外一科，辽宁大连 116011；19山东第一医科大学附属省立医院普通外科，山东济南 250021；20中南大学湘雅医学院附属肿瘤医院（湖南省肿瘤医院）肝胆肠外科，湖南长沙 410013；21中山大学附属第六医院普通外科，广东广州 510655；22郑州大学附属肿瘤医院（河南省肿瘤医院）普外科，河南郑州 450008
  • 出版日期:2025-07-01 发布日期:2025-07-27

  • Online:2025-07-01 Published:2025-07-27

摘要： 目的    分析局部进展期胃癌病人行新辅助治疗的临床病理特征、诊疗方案及疗效情况。方法    回顾性分析2018年1月至2023年12月22家大型三甲医院收治的接受新辅助治疗的局部进展期（cT1~2N+M0期或cT3~4bNxM0期）胃癌病人的真实世界病例资料，均行外科手术切除，并且术前至少完成1个周期新辅助治疗。结果    共纳入3892例病人，其中男性2945例（75.7%），女性947例（24.3%）。病人初诊年龄主要分布在：65~<70岁，871例（22.4%）；60~<65岁，724例（18.6%）；55~<60岁，640例（16.4%）。行新辅助化疗2460例（63.2%），新辅助化疗联合免疫治疗1173例（30.1%）。化疗方案主要为SOX方案［1771例（45.6%）］、FLOT4方案［470例（12.1%）］、XELOX方案［412例（10.6%）］；免疫治疗主要药物为信迪利单抗［577例（45.1%）］、替雷利珠单抗［175例（13.7%）］、特瑞普利单抗［123例（9.6%）］。新辅助化疗周期数依次为3个周期［1478例（38.0%）］、4个周期［1083例（27.9%）］和2个周期［866例（22.3%）］；新辅助免疫治疗周期数依次为3个周期［548例（42.9%）］、4个周期［317例（24.8%）］和2个周期［245例（19.2%）］。R0切除率为98.4%，494例达病理完全缓解（pCR），1053例为主要病理缓解（MPR）。新辅助化疗联合免疫治疗病人R0切除率（99.2% vs. 97.8%，P=0.005）、pCR率（21.6% vs. 9.5%，P＜0.001）和MPR率（39.8% vs. 23.6%，P＜0.001）均优于单纯新辅助化疗病人。新辅助化疗组与新辅助化疗联合免疫治疗组的不良反应发生率分别为21.9%和24.6%，术后并发症发生率分别为20.6%和24.4%，差异无统计学意义（P=0.122、0.341）。结论    局部进展期胃癌新辅助治疗中新辅助化疗联合免疫治疗占比逐渐增高；相较于单纯新辅助化疗，新辅助化疗联合免疫治疗显示出更高的R0切除率和病理缓解率，且不良反应和手术并发症发生率并未增加。

关键词: 胃癌, 新辅助治疗, 真实世界研究, 临床病理特征, 安全性

Abstract: To explore the clinical and pathological characteristics, treatment strategies, and outcomes of patients with locally advanced gastric cancer receiving neoadjuvant therapy. Methods    A retrospective analysis was conducted on the data of patients with locally advanced gastric cancer (cT1-2N+M0 or cT3-4bNxM0) who received neoadjuvant therapy and underwent surgical resection at 22 hospitals, between January 2018 and December 2023. All patients completed at least one cycle of neoadjuvant therapy prior to surgery. Results    A total of 3,892 patients were included in this study, including 2,945 males (75.7%) and 947 females (24.3%). The initial diagnosis age of patients was mainly concentrated in the age groups of 65-＜70 years (871 cases, 22.4%), 60-＜65 years (724 cases, 18.6%), and 55-＜60 years (640 cases, 16.4%). Among all patients, 2,460 (63.2%) received neoadjuvant chemotherapy, 1,173 (30.1%) received neoadjuvant chemotherapy combined with immunotherapy. The commonly used chemotherapy regimens in neoadjuvant treatment were SOX regimen (1,771 cases, 45.6%), FLOT4 regimen (470 cases, 12.1%), and XELOX regimen (412 cases, 10.6%). The commonly used immunotherapeutic agents were sintilimab (577 cases, 45.1%), tislelizumab (175 cases, 13.7%), and toripalimab (123 cases, 9.6%). The common number of cycles for neoadjuvant chemotherapy were three cycles (1,478 cases, 38.0%), four cycles (1,083 cases, 27.9%), and two cycles (866 cases, 22.3%); while for neoadjuvant immunotherapy, the common number of cycles were three cycles (548 cases, 42.9%), four cycles (317 cases, 24.8%), and two cycles (245 cases, 19.2%). The R0 resection rate for the entire cohort was 98.4%, with 494 cases achieving pathological complete response (pCR) and 1,053 cases achieving major pathological response (MPR). The group receiving neoadjuvant chemotherapy combined with immunotherapy had significantly higher R0 resection rate (99.2% vs. 97.8%, P=0.05), pCR rate  (21.6% vs. 9.5%, P<0.01), and MPR rate  (39.8% vs. 23.6%, P<0.01) compared to the group receiving neoadjuvant chemotherapy alone. The incidence rates of adverse reactions were 21.9% in the neoadjuvant chemotherapy group and 24.6% in the neoadjuvant chemotherapy combined with immunotherapy group (P=0.12), and the incidence rates of postoperative complications were 20.6% and 24.4%, respectively (P=0.34), with no statistically significant differences between the two groups. Conclusion    In China, the proportion of neoadjuvant chemotherapy combined with immunotherapy shows a progressive upward trend in managing locally advanced gastric cancer. Compared with single neoadjuvant chemotherapy, the combination of chemotherapy and immunotherapy has shown higher R0 resection rate and pathological response rate, without increasing the incidence of adverse reactions and compromising surgical safety.

Key words: gastric cancer, neoadjuvant therapy, real-world study, clinicopathological characteristics, safety