阿法替尼治疗晚期非小细胞肺癌的快速卫生技术评估

Afatinib for the treatment of advanced non-small cell lung cancer:a rapid health technology assessment

目的:评价阿法替尼治疗晚期非小细胞肺癌(NSCLC)的有效性、安全性和经济性,为临床治疗以及国家基本药物目录的准入提供循证依据。方法:通过计算机检索PubMed、Embase、the Cochrane Library、中国知网、万方等中英文数据库。由2位评价者根据纳入与排除标准独立筛选文献、提取资料,并进行定性分析和快速卫生技术评估。结果:从946篇文献中筛选纳入2篇卫生技术评估(HTA)报告、10篇SR/Meta分析和5篇经济学研究。与吉非替尼、厄洛替尼以及标准化疗相比,阿法替尼可以显著延长晚期NSCLC患者的无进展生存期(PFS,HR=0.57,95%CI:0.42~0.76;P<0.0001),但在总生存期(OS)方面未见明显改善(HR=0.91,95%CI:0.83~0.99;P=0.562)。对于经铂化疗失败后晚期鳞状NSCLC患者,阿法替尼较厄洛替尼能显著延长PFS(HR=0.82,95%CI:0.68~1.00;P=0.0427)和OS(HR=0.81,95%CI:0.69~0.95;P=0.0077)。安全性方面,与对照组相比,阿法替尼治疗后腹泻、皮疹和口腔炎的发生率明显升高(P值均<0.05),但因药物不良事件而停止治疗和致死性不良事件(FAEs)的发生率没有显著性差异。结论:阿法替尼治疗晚期NSCLC具有良好的有效性和安全性。

Objective:To evaluate the effectiveness,safety and economy of afatinib in advanced non-small cell lung cancer(NSCLC)patients,and provide evidence for clinical treatment and the National Essential Drug List access.Methods:English and Chinese databases such as PubMed,the Cochrane Library,Embase,CNKI,and Wanfang were searched.Two reviewers independently identified literatures,extracted data and assessed the quality of included studies based on inclusion and exclusion criteria.Results:We screened 946 literatures and finally included 2 HTA reports,10 systematic review/meta-analysis and 5 pharmacoeconomic studies.Compared with gefitinib,erlotinib or the standard chemotherapy,afatinib significantly prolonged PFS(HR=0.57,95%CI:0.42~0.76;P<0.0001)of advanced NSCLC patients,but there was no significant difference in OS(HR=0.91,95%CI:0.83~0.99;P=0.562).There were significant improvements in PFS(HR=0.82,95%CI:0.68~1.00;P=0.0427)and OS(HR=0.81,95%CI:0.69~0.95;P=0.0077)for afatinib compared with erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung.In terms of safety,afatinib significantly increased the incidence of diarrhea,rash and stomatitis,compared with the control group(P<0.05).However,there was no significant difference in FAEs and discontinuation of treatment due to AEs.Conclusion:Afatinib is an efficacious and safe choice in the treatment of patients with advanced NSCLC.