Abstract
背景与目的表皮因子受体酪氨酸激酶抑制剂（epidermal growth factor receptor tyrosine kinase inhibitor, EGFR-TKI）应用于非小细胞肺癌（non-small cell lung cancer, NSCLC）一线治疗取得较好的临床疗效，然而EGFR-TKI一线用药选择仍面临很多问题。本研究应用循证医学的方法对NSCLC患者临床特征及基因突变情况对一线EGFR-TKIs治疗及化疗获益进行分析，以便指导临床用药。方法用计算机检索Pubmed、Embase、American Society of Clinical Oncology（ASCO）、European Society for Medical Oncology（ESCO）及生物医学数据库等数据库，寻找出EGFR-TKI与化疗相比一线治疗NSCLC的疗效的随机对照研究（randomized controlled trials, RCT）。对纳入RCT进行资料提取和质量评价，采用Review Manager 5.2软件分析、对比NSCLC患者在TKI治疗中的疗效。结果纳入的14项研究，共5, 000例患者。Meta分析结果显示，EGFR基因突变的NSCLC患者，EGFR-TKIs治疗与化疗相比有较好的近期有效率（RR=2.31; 95%CI: 1.88-2.84）和延长无疾病进展时间（progression free survival, PFS）（HR=0.39; 95%CI: 0.30-0.49），总生存时间（overall survival, OS）上两者无明显差异（HR=0.99; 95%CI: 0.84-1.16）。临床选择（亚裔、腺癌、不吸烟）NSCLC患者，EGFR-TKIs一线治疗与化疗相比也有较好的近期有效率（RR=1.30; 95%CI: 1.15-1.47），PFS和OS无差异（HR=0.93; 95%CI: 0.58-1.49）（HR=0.91; 95%CI: 0.81-1.02）。未经选择的患者，一线EGFR-TKIs治疗有效率、PFS与化疗无差异，但OS劣于一线接受化疗患者。结论EGFR突变的NSCLC患者一线EGFR-TKIs获益更多；对于不能耐受化疗的亚裔、腺癌、不吸烟患者，推荐一线EGFR-TKIs治疗；未经选择的NSCLC患者一线EGFR-TKIs治疗临床无获益，而且一线EGFR-TKI治疗的OS明显低于一线化疗。
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