PD-1抑制剂对晚期非小细胞肺癌治疗的有效性和安全性的meta分析

Efficacy and safety of PD-1 inhibitors in the treatment of advanced non-small cell lung cancer:a meta-analysis

目的通过meta分析探讨PD-1抑制剂对晚期非小细胞肺癌(NSCLC)患者治疗的有效性和安全性,为临床应用提供循证参考。方法检索自建库起至2019年7月收录于Cochrane图书馆、PubMed、Embase、中国期刊全文数据库、维普数据库、万方数据库、CNKI的文献,全面收集PD-1抑制剂(试验组)对比多西他赛(对照组)治疗晚期NSCLC的临床随机对照试验(RCT),对符合标准的文献进行资料提取,并采用Cochrane系统评价手册5.1.0进行文献质量评价,采用RevMan 5.3软件对晚期NSCLC治疗的总生存期(OS)、无进展生存期(PFS)、总体药物不良反应(ADR)发生率、3~5级ADR发生率进行meta分析。结果共纳入4个RCT,包括2299例晚期NSCLC患者。meta分析结果显示:与对照组比较,试验组患者OS[HR=0.67,95%CI:0.61~0.74,P<0.01]和PFS[HR=0.80,95%CI:0.73~0.88,P<0.01]提高;试验组总体ADR发生率[RR=0.77,95%CI:0.74~0.81,P<0.01]和3~5级ADR发生率[RR=0.25,95%CI(0.17,0.39),P<0.01]均明显低于对照组,差异有统计学意义。结论PD-1抑制剂对晚期NSCLC患者治疗的有效性和安全性均优于多西他赛。

Objective To systematically evaluate the effectiveness and safety of PD-1 inhibitors in the treatment of patients with advanced non-small cell lung cancer(NSCLC),and to provide evidence-based references for clinical applications.Methods Retrieved the documents collected in the Cochrane Library,PubMed,Embase,Chinese Journal Full-text Database,VIP Database,Wanfang Database,CNKI from the establishment of the databases to July 2019.Randomized controlled trials(RCTs)about PD-1 inhibitors(the test group)compared with docetaxel(the control group)in treatment of advanced NSCLC were collected.Literatures that meet the criteria were extracted,extracted datas from the literatures that met the standard,and the Cochrane Systematic Review Manual 5.1.0 was used for quality evaluation of the literatures,the RevMan 5.3 software was used to perform meta-analysis on the overall survival(OS),progression-free survival(PFS),overall incidence adverse drug reaction(ADR),and incidence of grade 3 to 5 of ADR of the two groups.Results A total of 4 RCTs were included,including 2299 patients with advanced NSCLC.Meta analysis results show that,compared with the control group,the overall survival[HR=0.67,95%CI:0.61-0.74),P<0.01]and PFS[HR=0.80,95%CI:0.73-0.88),P<0.01]in the test group were improve;the overall incidence of ADR[HR=0.77,95%CI:0.74-0.81),P<0.01]and grades 3 to 5 of ADR[HR=0.25,95%CI:0.17-0.39,P<0.01]in the test group were significantly lower than those in the control group,the differences were statistically significant.Conclusion PD-1 inhibitors are more effective and safer for patients with advanced NSCLC than docetaxel.