Clinical efficacy analysis of immune checkpoint inhibitor combined with surgery in stage Ⅳ gastric cancer:A multicenter retrospective study

WANG Heng-yue; CHEN Jie; WANG Shu-chang; LUO Tian-hang; Huang-chen; ZHAGN Zi-zhen; ZHENG Rui; FANG Yuan; MA Jun-jun; ZHANG Lu-yang; LI Shu-chun; LIN Zhong-jun; ZHAO En-hao; LIU Feng-lin; ZANG Lu

doi:10.19538/j.cjps.issn1005-2208.2025.04.09

Abstract：Objectives To explore the efficacy and safety of applying immune checkpoint inhibitors combined with surgery in patients with stage Ⅳ gastric cancer or esophagogastric junction adenocarcinoma.Methods The clinical data of 112 patients with gastric cancer or esophagogastric junction adenocarcinoma who were treated with immune checkpoint inhibitors before surgery at 5 centers in Shanghai between May 2021 and August 2023 were retrospectively analyzed.The study cohort comprised 43 patients with stage cⅣ A and 69 patients with stage cⅣB.All patients received immune checkpoint inhibitors targeting the programmed cell death-1.Chemotherapy regimens mainly included SOX,XELOX regimen,etc.Targeted therapeutic drugs include trastuzumab and apatinib.Observation indicators include treatment-related adverse events,operation conditions and operation-related complications,the short-term efficacy,and the prognosis.Results In the whole group of 112 patients,the main treatment-related adverse events were bone marrow suppression and fatigue,among which grade Ⅲ and above adverse events accounted for 30.4％(34/112),and the main immune-related adverse events were rash and hypothyroidism with an incidence of immune-related adverse events was 19.6％(22/112).The median treatment period before surgery was 4(4,6),and the RO resection rate reached 82.1％(92/112).The incidence of surgery-related complications was 14.3％(16/112),mainly including anastomotic leakage and chylous leakage.There were 13 cases with grade Ⅰ to Ⅱ complications(11.6％),3 cases with grade Ⅲ complications(2.7％),and no case with grade Ⅳ or above complications.In the whole group,ORR was 79.5％(89/112),pCR rate was 20.5％(22/112),and MPR rate was 44.6％(50/112).The median follow-up time of the whole group was 22.6(95％CI 19.8-25.4)month,the median overall survival(OS)was 37.3(95％CI 20.6-54.0)months,and the median progression free survival(PFS)was 22.5(95％CI 15.8-29.2)months.The 1-and 2-year OS rates were 86.6％and 65.0％.The 1-and 2-year PFS rates were 73.2％and 44.9％.Conclusion For patients with stage Ⅳ gastric cancer or adenocarcinoma of esophagogastric junction,preoperative application of immune checkpoint inhibitors combined with surgery has a good therapeutic effect and prognosis.The incidence of treatment-related adverse reactions and surgery-related complications are acceptable.