PD-1抑制剂治疗晚期黑色素瘤疗效的Meta分析

Efficacy of PD-1 inhibitors in the treatment of advanced melanoma:A Meta analysis

目的:本文旨在系统评价PD-1抑制剂对比化疗及CTLA-4抑制剂治疗晚期黑色素瘤(advanced melanoma)的有效性和安全性,采用Meta分析方法。方法:计算机检索Cochrane图书馆、Pubmed、Embase、CNKI、CBM、万方数据库、维普数据库,作者独立提取资料,并反复核对,运用Cochrane量表评价纳入文献的方法学质量,同时采用RevMan5.3软件进行Meta分析。结果:本文共纳入8个随机对照试验,包括5 533例病例。Meta分析结果显示:PD-1抑制剂相比较于化疗在无进展生存期[HR=0.54,95%CI(0.48,0.60),P<0.000 01]、总生存期[HR=0.78,95%CI(0.65,0.93),P=0.005]、客观缓解率[RR=3.60,95%CI(2.70,4.80),P<0.000 01]高于对照组,任何级别不良反应事件[RR=0.90,95%CI(0.86,0.95),P<0.000 1],3,4,5级不良反应事件[RR=0.50,95%CI(0.42,0.60),P<0.000 01]低于对照组。PD-1抑制剂相比较于CTLA-4抑制剂在无进展生存期[HR=0.59,95%CI(0.52,0.66),P<0.000 01]、总生存期[HR=0.67,95%CI(0.58,0.76),P<0.000 01]、客观缓解率[RR=2.49,95%CI(2.15,2.88),P<0.000 01]高于对照组,任何级别不良反应事件[RR=0.99,95%CI(0.91,1.07),P=0.80],3,4,5级不良反应事件[RR=0.63,95%CI(0.42,0.96),P=0.03]低于对照组。结论:PD-1抑制剂方案治疗晚期黑色素瘤患者的疗效高于化疗及CTLA-4抑制剂,且安全性优于后者。

Objective:To systematically evaluate the efficacy and safety of PD-1 inhibitors versus chemotherapy and CTLA-4 inhibitors in the treatment of advanced melanoma by meta-analysis.Methods:Literatures were retrieved from the Cochrane Library,Pubmed,Embase,CNKI,CBM,Wanfang database,and Weipu database.The author independently extracted the data and repeatedly checked it.The Cochrane scale was used to evaluate the methodological quality of the included literature.RevMan5.3 software was used for Meta-analysis.Results:This article include a total of 8 randomized controlled trials,including 5 533 cases.Meta-analysis results showed that PD-1 inhibitors group(the trial group) was superior to the chemotherapy(the control group) in progression-free survival[HR= 0.54,95%CI(0.48,0.60),P<0.000 01],overall survival[HR=0.78,95%CI(0.65,0.93),P=0.005],objective response rate[RR=3.60,95%CI(2.70,4.80),P<0.000 01],and any grade of adverse events[RR=0.90,95%CI(0.86,0.95),P<0.000 1],grade 3,4,and 5 adverse events[RR= 0.50,95%CI(0.42,0.60),P<0.000 01] was lower than the control group.PD-1 inhibitors group(the trial group) was superior to the CTLA-4 inhibitors(the control group) in progression-free survival[HR=0.59,95%CI(0.52,0.66),P<0.000 01],overall survival [HR=0.67,95%CI(0.58,0.76),P<0.000 01],objective response rate[RR=2.49,95%CI(2.15,2.88),P<0.000 01],and any grade of adverse events[RR=0.99,95%CI(0.91,1.07),P=0.80],grade 3,4,5 adverse events[RR=0.63,95%CI(0.42,0.96),P=0.03] was lower than the control group.Conclusion:The PD-1 inhibitors regimen is more effective than chemo-therapy and CTLA-4 inhibitors in the treatment of advanced melanoma patients,and the safety is better than the latter.