摘要
Abstract
Objective To explore the short-term efficacy and safety of immunotherapy in the neoadjuvant therapy for locally advanced gastric cancer(LAGC).Methods The clinicopathological data of 73 LAGC patients who received neoadjuvant therapy at our hospital from September 2021 to December 2023 were retrospectively analyzed.The patients were divided into the neoadjuvant immunotherapy com-bined with chemotherapy group(n=38)and the chemotherapy alone group(n=35)according to whether immunotherapy was added.The short-term efficacy of the two groups was analyzed,including overall response rate(ORR),disease control rate(DCR),pathologic complete response(pCR)rate and main pathologic response(MPR)rate.Subgroup analysis was performed to explore the population that could ben-efit from neoadjuvant immunotherapy.Results The ORRs of the neoadjuvant immunotherapy combined with chemotherapy group and the chemotherapy alone group were 47.4%and 14.3%,respectively(P=0.002),while the DCRs were 97.4%and 91.4%,respectively(P>0.05).The neoadjuvant immunotherapy combined with chemotherapy group was superior to the chemotherapy alone group in terms of the overall tumor regression grade(TRG,P=0.049),with an increased pCR rate(25.0%vs 3.3%,P=0.023).However,there was no significant differ-ence in MPR between the two groups(42.9%vs 23.3%,P>0.05).Subgroup analysis based on programmed death-ligand 1(PD-L1)showed that there were no significant differences in TRG,pCR,and MPR between patients with combined positive score(CPS)≥1 and CPS<1(all P>0.05).The pCR rates of patients with CPS≥5 and CPS<5 were 100.0%and 13.6%,respectively(P<0.05),while the MPR rates were 100.0%and 36.4%,respectively(P>0.05).Among patients with clinical stage Ⅱ,there were no significant differences in TRG,pCR,and MPR between the neoadjuvant immunotherapy combined with chemotherapy group and the chemotherapy alone group(all P>0.05).In patients with stage Ⅲ,the neoadjuvant immunotherapy combined with chemotherapy group had a better TRG(P=0.026)and an increased pCR rate(31.6%vs 0.0%,P=0.024),but there was no significant difference in MPR between the two groups(P>0.05).There were no sig-nificant differences in the incidence of all adverse reactions and grade 3-4 adverse reactions during neoadjuvant therapy and the incidence of perioperative complications between the two groups(all P>0.05).Conclusions Immunotherapy has good short-term efficacy and safety in the neoadjuvant treatment of LAGC.It can improve pCR,especially in patients with PD-L1 CPS≥5 and stage Ⅲ.However,its long-term efficacy needs to be confirmed by further follow-up and clinical studies.关键词
局部进展期胃癌/免疫治疗/新辅助化疗/短期疗效/安全性Key words
locally advanced gastric cancer/immunotherapy/neoadjuvant chemotherapy/short-term efficacy/safety