阿法替尼治疗晚期非小细胞肺癌的Meta分析

目的:评价阿法替尼治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效及安全性.方法:通过PubMed、The Cochrane Library、Web of Science、EMbase、万方数据库和中国期刊全文数据库,检索阿法替尼治疗晚期NSCLC的随机临床对照试验.提取资料,采用RevMan5.3进行Meta分析.结果:纳入6项RCT研究,2 610例患者,荟萃分析显示阿法替尼治疗可显著延长晚期NSCLC的无进展生存期(progression-free survival,PFS)(HR=0.59,95%CI:0.46~0.74,P<0.000 1).亚组分析示阿法替尼组较传统化疗组(HR=0.54,95%CI:0.45~0.64,P<0.000 01)及一代EGFR-TKI组(HR=0.79,95%CI:0.67~0.92,P=0.002)PFS改善更加明显,差异有统计学意义.同时,阿法替尼治疗亦可延长患者的总生存期(overall survival,OS)(HR=0.90,95%CI:0.82~0.99,P=0.03).亚组分析示阿法替尼组较一代EGFR-TKI组(HR=0.82,95%CI:0.72~0.95,P=0.006)OS改善更加明显,差异有统计学意义;而与传统化疗组(HR=0.93,95%CI:0.78~1.10,P=0.38)相比,OS改善未显示出明显优势.安全性方面,阿法替尼治疗最主要的不良反应为腹泻(RR=9.99,95%CI:5.61~17.78,P<0.000 01)和口腔炎(RR=14.67,95%CI:4.72~45.56,P<0.000 01)而皮疹、乏力、食欲下降、恶心、呕吐不良反应,两组差异均无统计学意义.结论:阿法替尼治疗可延长晚期NSCLC患者的PFS及OS,与传统化疗及一代EGFR-TKI相比有明显优势.并具有良好安全性,可作为药物治疗晚期NSCLC的优先选择.

A systematic review:The efficacy and safety of Afatinib in the treatment of advanced non-small cell lung cancer

Objective:To review the effectiveness and safety of Afatinib in the treatment of advanced non-small cell lung cancer.Methods:Afatinib in the treatment of advanced non-small cell lung cancer were searched through PubMed,The Cochrane Library,Web of Science,EMbase,Wanfang data and CNKI to collect randomized controlled trials(RCTs).The bias of data was analyzed by using RevMan5.3 software,Begg's funnel plot and Egger's methods.Results:Totally 6 RCTs including 2 610 patients were analyzed.The Meta-analyses showed that Afatinib significantly prolonged the PFS(HR=0.59,95%CI:0.46~0.74,P<0.000 1).Subgroup analysis show that compared with the chemotherapy alone(HR=0.54,95%CI:0.45~0.64,P<0.000 01)and first EGFR-TKI(HR=0.79,95%CI:0.67~0.92,P=0.002),Afatinib significantly prolonged the PFS,respectively.Afatinib also significantly prolonged the OS(HR=0.90,95%CI:0.82~0.99,P=0.03).Subgroup analysis show that compared with the first EGFR-TKI(HR=0.82,95%CI:0.72~0.95,P=0.006),Afatinib significantly prolonged the OS.But showed no significantly greater in chemotherapy group(HR=0.93,95%CI:0.78~1.10,P=0.38).The main adverse reactions were diarrhea(RR=9.99,95%CI:5.61~17.78,P<0.000 01) and stomatitis(RR=14.67,95%CI:4.72~45.56,P<0.000 01).Grade 3/4 rash,fatigue,decreased appetite,nause and vomiting,the difference between the two groups had no statistical significance.Conclusion:Afatinib significantly prolonged PFS and OS of advanced NSCLC patients.The major adverse event Afatinib caused diarrhea,stomatitis,and all can be tolerated.Afatinib could be an option as first line drug for advanced non-small cell lung cancer.