晚期食管癌PD-1/PD-L1免疫检查点抑制剂疗法的Cochrane Meta分析  

PD-1/PD-L1 immune checkpoint inhibitor therapy of advanced esophageal cancer:a Cochrane Meta-analysis

作　　者：许雨柔 邹宜丰 蔡宁 范佳慧 陈兴栋 索晨[2] XU Yu-rou;ZOU Yi-feng;CAI Ning;FAN Jia-hui;CHEN Xing-dong;SUO Chen(Department of Epidemiology,School of Public Health,Fudan University,Shanghai 200032,China;Key Laboratory of Public Health Safety(Fudan University),Ministry of Education,Shanghai 200032,China;State Key Laboratory of Genetic Engineering,Human Phenome Institute,Fudan University,Shanghai 200438,China;Taizhou Institute of Health Sciences,Fudan University,Taizhou 225300,Jiangsu Province,China;Yiwu Research Institute,Fudan University,Yiwu 322000,Zhejiang Province,China)

机构地区：[1]复旦大学公共卫生学院流行病学系,上海200032 [2]复旦大学公共卫生安全教育部重点实验室,上海200032 [3]复旦大学人类表型组研究院遗传工程国家重点实验室,上海200438 [4]复旦大学泰州健康科学研究院,泰州225300 [5]复旦大学义乌研究院,义乌322000

出　　处：《复旦学报（医学版）》2023年第5期660-669,682,共11页Fudan University Journal of Medical Sciences

基　　金：上海市“科技创新行动计划”自然科学基金(20ZR1405600);国家重点研发计划(2019YFC1315804);国家自然科学基金(82073637,82122060)。

摘　　要：目的评价现有免疫检查点抑制剂疗法对接受手术、放疗或化疗的食管癌患者的疗效和安全性,比较使用与不使用免疫检查点抑制剂治疗方案的疗效。方法计算机检索Cochrane Library、PubMed、Embase等数据库,查询食管癌免疫疗法的相关研究,采用RevMan5.4软件进行Meta分析。纳入的研究为临床Ⅱ期或Ⅲ期的双盲随机对照试验(randomized controlled trials,RSTs)。结果共纳入10项RSTs,包含6497例晚期食管癌患者。Meta分析结果显示,使用PD-1/PD-L1抑制剂干预的免疫检查点抑制剂疗法和/或联合手术、放化疗,能有效提高食管癌患者的总体生存率(overall survival,OS)(HR=0.75,95%CI:0.71~0.80,P<0.0001;异质性:I^(2)=48%,P=0.05)、无进展生存期(progression-free survival,PFS)(HR=0.77,95%CI:0.66~0.90,P=0.0008;异质性:I^(2)=90%,P<0.001)、客观缓解率(objective response rate,ORR)(RR=1.28,95%CI:1.20~1.36,P<0.0001;异质性:I^(2)=49%,P=0.06)和疾病控制率(disease control rate,DCR)(RR=1.07,95%CI:1.02~1.12,P=0.003;异质性:I^(2)=28%,P=0.24),且具有可管理的安全性。结论基于PD-1/PD-L1抑制剂的免疫检查点抑制剂疗法和/或联合传统疗法可以提高食管癌的总体生存水平和疗效,显示出优于传统放化疗的安全性。Objective To evaluate the efficacy and toxicity of existing immune checkpoint inhibitor therapy in patients with esophageal cancer undergoing surgery,radiotherapy or chemotherapy,and to compare the efficacy of different treatment strategies.Methods Literatures from Cochrane Library,PubMed,EMBASE were searched to query the related studies of immunotherapy for esophageal cancer.Revman5.4 was used for Meta-analysis.The inclusion criteria for the studies were double-blind randomized controlled trials in clinical phaseⅡorⅢ.Results A total of 10 randomized controlled trials(RCTs)and 6497 patients with advanced esophageal cancer.Meta-analysis showed that the immune checkpoint inhibitor therapy of PD-1/PD-L1 inhibitor and/or combined operation,radiotherapy and chemotherapy can effectively improve the overall survival(OS)(HR=0.75,95%CI:0.71-0.80,P<0.0001;heterogeneity:I^(2)=48%,P=0.05),progression-free survival(PFS)(HR=0.77,95%CI:0.66-0.90,P=0.0008;heterogeneity:I^(2)=90%,P<0.001),objective response rate(ORR)(RR=1.28,95%CI:1.20-1.36,P<0.0001;heterogeneity:I^(2)=49%,P=0.06)and disease control rate(DCR)(RR=1.07,95%CI:1.02-1.12,P=0.003;heterogeneity:I^(2)=28%,P=0.24)of esophageal cancer with manageable safety.Conclusion Immunotherapy for esophageal cancer based on PD-1/PD-L1 immune checkpoint inhibitors and/or combined traditional therapy can improve the overall survival and overall response of esophageal cancer,which shows better safety than traditional radiotherapy and chemotherapy.

关 键 词：食管癌 免疫疗法 免疫检查点抑制剂 随机对照试验(RST) META分析 

分 类 号：R735.1[医药卫生—肿瘤] R730.51[医药卫生—临床医学]