EGFR-TKIs二线治疗EGFR野生型非小细胞肺癌的系统评价

EGFR Tyrosine Kinase Inhibitors in Treatment of Non-small Cell Lung Cancer Patients with Wild-Type EGFR:A Meta-Analysis

[目的]评价化疗与TKI二线治疗EGFR野生型的NSCLC患者的疗效,为临床用药提供参考。[方法]计算机检索Pub Med、Clinical Trials.gov、CNKI中文数据库,按照制订的纳入与排除标准筛选关于化疗与TKI二线治疗EGFR野生型的NSCLC患者的研究,检索时限为数据库建库至2015年12月。使用Rev Man5.4.1进行统计分析。[结果]共纳入7项研究。Meta分析发现：（1）二线治疗接受TKI的EGFR野生型患者与接受化疗的患者ORR无显著性差异,合并OR为0.68（95%CI：0.30~1.51）;（2）在野生型NSCLC患者,化疗二线治疗野生型NSCLC患者PFS获益较TKI有效,合并HR为1.27（95%CI：1.4~1.55）;（3）与化疗相比,TKI并未使野生型EGFR的NSCLC患者OS获益,合并HR为1.09（95%CI：0.95~1.25）。[结论 ]化疗二线治疗野生型EGFR的NSCLC患者可延长患者PFS,生存获益优于TKI;但PFS获益并未转换为OS获益。

[Objective] To review the efficacy of tyrosine kinase inhibitors（TKI） in treatment of non-small cell lung cancer（NSCLC） patients with wild-type EGFR. [Methods] The database of Pubmed,Clinical Trials.gov and CNKI were searched for studies on TKI and chemotherapy as second-line or further-line treatment in NSCLC patients. A total of 7 RCTs were included in the meta-analysis. Objective response rate（ORR）,progression-free survival（PFS） and overall survival（OS） were analyzed from included studies. [Results] The pooled ORR of TKI/chemotherapy in wild-type EGFR NSCLC patients was 0.68（95%CI：0.30~1.51）. Among wild-type NSCLC patients,PFS benefited from chemotherapy（HR=1.27,95%CI：1.4~1.55）. However,the PFS benefit failed to translate into improvement in OS（HR =1.09,95% CI：0.95 ~1.25）. [Conclusions] In patients with wild-type EGFR,chemotherapy improves PFS significantly compared with TKI.