EGFR-TKI联合化疗对比单用EGFR-TKI治疗EGFR突变的晚期非小细胞肺癌疗效与安全性Meta分析

EGFR-TKI Plus Chemotherapy Versus EGFR-TKI Alone in Non-small Cell Lung Cancer with EGFR Mutations:a Meta-analysis

[目的]评价表皮生长因子受体酪氨酸激酶抑制剂（epidermal growth factor receptortyrosine kinase inhibitor,EGFR-TKI）联合化疗治疗EGFR突变的晚期非小细胞肺癌（non-small cell lung cancer,NSCLC）患者的疗效与安全性。[方法]计算机系统检索PubMed及其他数据库中截止至2017年10月所有使用EGFR-TKI联合化疗对比单用EGFR-TKI治疗EGFR突变晚期NSCLC患者的随机对照试验（randomized controlled trial,RCT）。[结果]包含862例患者的5项临床研究符合纳入条件。EGFR-TKI联合化疗可显著延长EGFR突变的晚期NSCLC患者的无进展生存期（progression-free survival,PFS）（HR=0.72,95%CI：0.58～0.91,P=0.006）。两种治疗方式的客观反应率（objective response rate,ORR）（RR=1.06,95%CI：0.94～1.19,P=0.35）及总生存期（overall survival,OS）（HR=1.00,95%CI：0.68～1.47,P=0.99）无差异显著性。两种治疗方法的不良事件（adverse event,AE）发生率较低且相近。[结论] EGFR-TKI联合化疗在EGFR突变的晚期NSCLC患者中极具应用前景,值得进一步研究。

[Purpose] To assess the efficacy and safety of epidermal growth factor receptor-tyrosine kinase inhibitor（EGFR-TKI） plus chemotherapy in treating patients having advanced non-small cell lung cancer（NSCLC） with EGFR mutations. [Methods] PubMed,Cochrane Library,Embase and ClinicalTrials. gov were searched for randomized controlled trial（RCT） on EGFR-TKI plus chemotherapy in treating advanced NSCLC patients with EGFR mutations up to April,2017. [Results] Five RCTs involving 862 patients were eligible. Our meta-analysis demonstrated that EGFR-TKIs plus chemotherapy was significantly better than EGFR-TKI alone in progress free survival（PFS）（HR=0.72,95%CI：0.58～0.91,P=0.006） for advanced NSCLC patients with EGFR mutations. No significant differences were found in either ORR（RR=1.06,95%CI：0.94～1.19,P=0.35） or OS（HR=1.00,95% CI：0.68 ～1.47,P =0.99）. The adverse effect（AE） of both treatments was similarly low.[Conclusion] EGFR-TKI plus chemotherapy is a promising treatment for advanced NSCLC patients with EGFR mutations.