Meta-analysis Of Efficacy And Safety Of Immunotherapy In Patients With Advanced Gastric Cancer

Background and Objective:Immune checkpoint inhibitor(ICIs)shows a good application prospect in advanced gastric cancer,and many clinical trials have been carried out.In this study,we used meta analysis to evaluate the efficacy and safety of ICIs in patients with advanced gastric cancer.Methods:Wanfang data,CNKI,CBM,Pub Med,Cochrane Library,Web of Science and other large English databases was searched to find the published literatures about clinical trials of immune checkpoint inhibitors in the treatment of advanced gastric cancer in the past 10 years.The data were obtained and statistically analyzed by Review Manager5.3 software.The efficacy evaluation mainly analyzed the median OS and median PFS,and the setting subgroup analysis mainly included immunosuppressant category,patient age,patient sex,area,MSI-H and so on.In addition,the safety of treatment was analyzed by comparing the occurrence of adverse reactions among the groups.Results:Finally,6 articles were included,all of which were RCT trials,including a total of 4042 patients,of which 4 were PD-1 treatment trials and 2 were PD-L1treatment trials.The results showed that immunotherapy could significantly improve OS compared with traditional chemotherapy(HR:0.84%;95%CI:0.73-0.97;P=0.02;I2=62%),and PD-1 inhibitor was more effective than PD-L1 inhibitor(HR=0.77,95%CI:0.70-0.86 VS HR=0.98,95%CI:0.84-1.14),but PFS had no significant difference.PD-1 therapy may be more effective in PD-L1 positive patients(HR=0.82,95%CI 0.70-0.97,P=0.02,I2=60%).The ORR of patients with MSI-H was significantly higher than that of MSS patients(HR=0.32,95%CI 0.19-0.54,P<0.001,I2=0%).The overall incidence of adverse reactions and the incidence of severe adverse reactions(≥grade 3)in the anti-PD-1/PD-L1 group were lower than those in the chemotherapy group.Conclusion:Immunotherapy improved OS in patients with advanced gastric cancer,but did not prolong PFS.Sex,age and area had no significant influence on the curative effect of ICIs.Patients with PD-L1 positive and MSI-H had higher clinical benefits;PD-1 inhibitors significantly prolonged OS;immunotherapy in patients with advanced gastric cancer compared with chemotherapy,the overall incidence of adverse events(RR=0.77,95%CI 0.61-0.97,P=0.03,I2=92%)and severe TRAE(≥grade3)(RR=0.50,95%CI 0.30-0.85,P=0.01,I~2=92%)were lower,and may have higher safety.