ICI联合化疗一线治疗广泛期小细胞肺癌效果及安全性的Meta分析  

Efficacy and safety of ICI combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer:a meta-analysis

作　　者：蒋美桥 邵丽华 董玉梅 马晶 魏世鸿 Jiang Meiqiao;Shao Lihua;Dong Yumei;Ma Jing;Wei Shihong(College of Integrative Chinese and Western Medicine,Gansu University of Traditional Chinese Medicine,Lanzhou 730030,China;Department of Radiotherapy,Gansu Hospital,Sun Yat-sen University Cancer Hospital,Lanzhou 730050,China)

机构地区：[1]甘肃中医药大学中西医结合学院,兰州730030 [2]中山大学附属肿瘤医院甘肃医院放疗科,兰州730050

出　　处：《肿瘤研究与临床》2024年第10期773-783,共11页Cancer Research and Clinic

基　　金：甘肃省卫生健康行业科研计划(GSWSKY2021-057)。

摘　　要：目的探讨免疫检查点抑制剂(ICI)程序性死亡受体1(PD-1)抑制剂、程序性死亡受体配体1(PD-L1)抑制剂治疗广泛期小细胞肺癌(ES-SCLC)的疗效及安全性。方法检索中国知网、万方、维普、PubMed、Embase和Cochrane临床对照试验中心注册(CENTRAL)数据库,查阅自建库至2023年10月4日公开发表的ICI治疗ES-SCLC的随机对照试验文献。按照纳入排除标准筛选文献和提取资料后,应用Review Manager 5.4软件评估研究的偏倚风险,对全组和肝转移、脑转移亚组中ICI联合化疗(试验组)与化疗±安慰剂(对照组)患者疾病缓解、预后、不良事件(AE)等进行比较。结果共纳入随机对照试验11篇文献,试验组2243例,对照组2059例。纳入的研究数据完整且未见选择性偏倚。与对照组相比,试验组患者的客观缓解率(ORR)高[对照组比试验组,64%(864/1358)比70%(1088/1532),RR=1.08(95%CI:1.03~1.14),P=0.003],差异有统计学意义;无进展生存(PFS)[试验组比对照组中位PFS时间,5.14个月(95%CI:4.88~5.40个月)比4.76个月(95%CI:4.70~4.82个月),HR=0.72(95%CI:0.67~0.78),P<0.001]和总生存(OS)[试验组比对照组中位OS时间,12.89个月(95%CI:12.18~13.60个月)和10.41个月(95%CI:10.03~10.79个月),HR=0.72(95%CI:0.67~0.78),P<0.001]均得到改善,差异均有统计学意义。基线肝转移试验组患者OS优于对照组[试验组比对照组,HR=0.82(95%CI:0.71~0.95),P=0.009],差异有统计学意义,而基线脑转移试验组和对照组患者OS差异无统计学意义[试验组比对照组,HR=0.84(95%CI:0.66~1.08),P=0.170]。试验组AE发生率[试验组比对照组,31%(597/1952)(95%CI:24%~37%)比14%(255/1762)(95%CI:9%~22%),RR=2.25(95%CI:1.67~3.02),P<0.001]和因AE导致停药或剂量改变发生率[试验组比对照组,21%(379/1774)(95%CI:12%~41%)比19%(307/1588)(95%CI:6%~25%),RR=1.20(95%CI:1.07~1.33),P=0.001]均较对照组高,差异均有统计学意义;但试验组和对照组严重(≥3级)AE发生率均为34%(620/1814、557/1632)(均95%CI:32Objective To investigate the efficacy and safety of immune checkpoint inhibitors(ICI),programmed death receptor 1(PD-1)inhibitors and programmed death receptor-ligand 1(PD-L1)inhibitors in the treatment of extensive-stage small cell lung cancer(ES-SCLC).Methods The databases of CNKI,Wanfang,VIP,China Biology Medicine disc,PubMed,Embase,and Cochrane Clinical Controlled Trial Center Registry(CENTRAL)were retrieved,and the randomized controlled trial literature on the treatment of ES-SCLC with immune checkpoint inhibitors published from the establishment of the database until October 4,2023 were reviewed.After screening literature and extracting data according to inclusion and exclusion criteria,the risk of bias in the study was evaluated using Review Manager 5.4 software.The disease remission,prognosis and adverse events(AE)of patients treated with ICI combined with chemotherapy(experimental group)and placebo±chemotherapy(control group)in the whole group and liver metastases and brain metastases subgroups were compared.Results A total of 11 randomized controlled trials were included,with 2243 cases in the experimental group and 2059 cases in the control group.The included research data were complete and showed no selective bias.Compared with the control group,the objective response rate(ORR)of patients in the experimental group was higher[control group vs.experimental group,64%(864/1358)vs.70%(1088/1532),RR=1.08(95%CI:1.03-1.14),P=0.003],and the difference was statistically significant;progression free survival(PFS)[experimental group vs.control group,the median PFS time,5.14 months(95%CI:4.88-5.40 months)vs.4.76 months(95%CI:4.70-4.82 months),HR=0.72(95%CI:0.67-0.78),P<0.001]and overall survival(OS)[experimental group vs.control group,the median OS time,12.89 months(95%CI:12.18-13.60 months)vs.10.41 months(95%CI:10.03-10.79 months),HR=0.72(95%CI:0.67-0.78),P<0.001]were all improved,and the differences were statistically significant.The OS of patients with baseline liver metastasis in the experimental group was be

关 键 词：肺肿瘤 癌 小细胞 免疫疗法 免疫检查点抑制剂 药物疗法 预后 

分 类 号：R734.2[医药卫生—肿瘤]