阿法替尼治疗晚期非小细胞肺癌有效性和安全性的系统评价

Efficacy and safety of afatinib in the treatment of advanced non-small cell lung cancer: a systematic review

目的系统评价阿法替尼治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的有效性和安全性。方法计算机检索The Cochrane Library、Pub Med、EMbase、CNKI、Wan Fang Data和VIP数据库,搜集有关阿法替尼治疗晚期非小细胞肺癌的随机对照试验(RCT),检索时限均为建库到2016年10月。由两位评价者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入8个RCT。Meta分析结果显示:阿法替尼可明显延长腺癌患者的无进展生存期[HR=0.43,95%CI(0.32,0.57),P<0.000 01],但两组在腺癌患者的总生存期方面差异无统计学意义[HR=1.03,95%CI(0.85,1.23),P=0.79]。阿法替尼会明显增加患者的不良反应,包括腹泻、皮疹、恶心、呕吐等。结论阿法替尼可改善晚期NSCLC中腺癌患者的无进展生存期,但无法延长总体生存期。受纳入研究的数量和质量限制,上述研究尚需开展更多高质量研究予以验证。

Objective To systematically review the clinical efficacy and safety of afatinib in the treatment of advanced non-small cell lung cancer （NSCLC）. Methods We electronically searched databases including The Cochrane Library, PubMed, EMbase, CNKI, WanFang Data and VIP to collect randomized controlled trials （RCTs） about the afatinib for advanced non-small cell lung cancer from inception to October 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. Results Eight RCTs were included. The results of meta-analysis showed that afatinib could significantly prolonged progression-free survival （PFS） for lung adenocarcinoma patients （HR=0.43, 95%CI 0.32 to 0.57, P〈0.000 01）, but there was no significant difference between the two groups in terms of overall survival （OS） in patients with lung adenocarcinoma （HR=1.03, 95%CI 0.85 to 1.23, P=0.79）. In addition, afatinib significantly increased the patient＇s adverse reactions including diarrhea, skin rashes, nausea and vomiting. Conclusion Afatinib can improve PFS in patients with lung adenocarcinoma, but it does not prolong OS. Due to the limited quantity and quality of included studies, the above conclusions are still needed to be verified by more high quality studies.