PD-1/PD-L1抑制剂与化疗治疗晚期非小细胞肺癌疗效的Meta分析

目的:本文旨在系统评价PD-1/PD-L1抑制剂对比化疗治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)的有效性和安全性,采用Meta分析方法.方法:计算机检索Cochrane Library、PubMed、EM-Base、CNKI、万方数据库、VIP数据库,两名评价者独立评价纳入研究的质量、提取资料并交叉核对,运用Co-chrane量表评价纳入文献的方法学质量同质研究采用RevMan 5.3软件进行Meta分析.结果:共纳入5个随机对照试验,包括3042例病例.Meta分析结果显示:PD-1/PD-L1抑制剂相比较于对照组在总有效率OR=1.58,95%CI(1.27,1.97),P<0.0001]、总生存期HR=0.68,95%CI(0.62,0.75),P<0.00001]、无进展生存期HR=0.79,95%CI(0.72,0.86),P<0.00001]高于对照组.在亚组分析中,PD-1/PD-L1抑制剂相比较于对照组在EGFR突变型的肺癌HR=0.91,95%CI(0.76,1.11),P=0.35]中无明显差异,在EGFR野生型的肺癌HR=0.67,95%CI(0.60,0.76),P<0.00001]中有差异.任何级别不良反应事件OR=0.32,95%CI(0.27,0.39),P<0.00001]和3、4、5级不良反应事件OR=0.18,95%CI(0.11,0.30),P<0.00001]低于对照组.结论:PD-1/PD-L1抑制剂方案治疗晚期NSCLC患者的疗效高于以多西他赛为主的化疗方案,且安全性优于后者.

Efficacy and safety of antibodies targeting PD-1 / PD-L1 inhibitors versus chemothera-py in the treatment of advanced non-small cell lung cancer:A Meta-analysis

Objective:To evaluate the efficacy and safety of PD-1/ PD-L1 inhibitors in the treatment of non-small cell lung cancer (NSCLC)by Meta-analysis.Methods:Retrieved from Cochrane Library,PubMed,EMBase, CNKI,Wanfang database,VIP database,RCT about PD-1/ PD-L1 inhibitors versus chemotherapy for advanced NSCLC were included.Two reviewers independently screened literature,extracted data and assessed the risk of bias of the included studies.Results:Meta-analysis results indicated that the PD-1/ PD-L1 inhibitors group (the trial group)was superior to the chemotherapy group (the control group)in objective response rate (ORR)OR = 1.58, 95% CI(1.27,1.97),P< 0.0001],overall response rate HR = 0.68,95% CI(0.62,0.75),P< 0.00001],pro-gression-free-survival response rate HR = 0.79,95% CI(0.72,0.86),P< 0.00001].In the results of subgroup analysis,the HR for OS in NSCLC patients was HR = 0.91,95% CI(0.76,1.11),P = 0.35]in patients with mu-tant EGFR and HR = 0.67,95% CI(0.60,0.76),P< 0.00001]in patients with wild-type EGFR status.In terms of safety,any grade treatment-related adverse OR = 0.32,95% CI(0.27,0.39),P< 0.00001]and grade 3 to 5 treatment-related adverse effect OR = 0.18,95% CI(0.11,0.30),P< 0.00001]in the trial group were lower than the control group.Conclusion:Compared with chemotherapy,the efficacy of PD-1/ PD-L1 inhibitors regimen in the treatment of patients with advanced NSCLC was significantly higher than that of docetaxel-based chemothera-py,and the safety was superior to the latter.