中文摘要：

目的 评价阿法替尼治疗EGFR突变型晚期非小细胞肺癌的有效性与安全性。方法 计算机检索Cochrane图书馆、Pub Med、Embase、CNKI、万方数据库。两名评价者独立评价纳入研究的质量、提取资料并交叉核对,同质研究采用Rev Man 5.3软件进行meta分析,对不能合并的数据采用描述性分析。主要结局指标包括无进展生存期（Progression free survival,PFS）、总生存期（Overall survival,OS）及毒性反应。结果 纳入4篇RCT,共2144例患者,EGFR突变1007例,实验组670例,对照组307例,Meta结果显示阿法替尼可显著延长EGFR突变型晚期非小细胞肺癌患者的PFS,差异有统计学意义（HR=0.49,95%CI：0.43~0.56,P〈0.001）,但对患者的OS（HR=1.07,95%CI：0.90~1.27,P=0.47）无明显改善。对毒性反应进行meta分析,阿法替尼组增加了患者3级以上腹泻（RR=37.19,95%CI：7.42~186.32,P〈0.0001）、皮疹（RR=24.28,95%CI：6.01~98.06,P〈0.00001）、便秘（RR=15.42,95%CI：3.75~63.36,P=0.0001）的发生率。结论 阿法替尼可显著延长EGFR突变型晚期非小细胞肺癌的PFS,无论年龄、性别、种族、EOCG评分、突变位点及吸烟史的EGFR阳性患者均可获益,但对患者的OS无明显改善,阿法替尼增加了腹泻、皮疹及便秘的发生率,副反应相对可控,严重不良反应发生率低,安全性较高,可作为晚期非小细胞肺癌患者的一线用药选择。

英文摘要：

Objective To review the effectiveness and safety of Afatinib in the treatment of advanced non-small cell lung cancer harbouring EGFR mutations. Methods The Cochrane Library, Pubmed, Embase, CBM, CNKI and V1P were searched. The quality of trials was evaluated by 2 reviewers independently. The randomized controlled trials （RCTs） were analyzed by RevMan 5.3 software, and those data which cannot be merged got descriptive analysis. The outcomes included progression-free survival （PFS）, overall survival （OS） and toxicity. Results Data of 2144 patients from four III phase trials were analyzed, totally 1007 cases of EGFR（＋）, 670 cases in the afatinib group, and 307 eases in the control group. Compared with chemotherapy alone, afatinih significantly prolonged the PFS （HR=0.49, 95% CI： 0,43-0.56, P 〈 0.001）, but showed no significantly greater effect on the OS in patients with EGFR mutations （HR=1.07, 95% CI： 0.90-1.27, P= 0.47）. In addition, afatinib increased the risk of grade ≥3 diarrhoea （95% CI： 7.42-186.32, P〈0.0001）, rash or acne （RR=24.28, 95% CI： 6.01-98.06, P〈0.00001）, constipation （RR=15.42, 95% CI： 3.75-63.36, P= 0.0001）. Conclusion Afatinib significantly prolonged PFS of advanced NSCLC patients with EGFR mutations, including all subgroups of sex, smoking, EOCG scores, EGFR mutation sites. But afatinib could not improve the OS of patients. The major adverse event afatinib caused were diarrhea, rash/acne, constipation, and all can be tolerated. Afatinib could be an option as first line drug for advanced non-small cell lung cancer.