一线用药EGFR-TKIs与化疗治疗非选择型NSCLC效果的Meta分析

A meta-analysis on effectiveness of EGFR-TKIs compared with chemotherapy as first line treatment of the unselected non-small-cell lung cancer

目的系统评价一线用药表皮生长因子受体酪氨酸激酶抑制剂（EGFR—TKIs）与化疗治疗非选择型非小细胞肺癌（NSCLC）的效果。方法白PubMed、CochraneLibrary、EMBASE中检索相关的主题词及自由词．收集EGFR—TKIs与化疗相比一线治疗非选择型NSCLC效果的随机对照研究（RCT）。按纳入及排除标准筛选文献，采用Cochrane偏倚风险评估表对纳入文献进行质量评价，自纳入文献中提取有效数据．应用RevMan5．3．5和STA—TA12．0分析并对比非选择型NSCLC患者在EGFR—TKIs治疗中的效果。敏感性分析和发表偏倚分析评价结果的稳定性和可靠性。结果共纳入7篇RCT．共2612例患者，Meta分析结果显示．对于非选择型晚期NSCLC患者：一线EGFR—TKIs治疗的PFS（日R=1．18；95％CI：0．96～1．45；P=0．12）、OS（HR=I．24；95％CI：0．97～1．57；P=0．08）、ORR（RR=0．71；95％CI：0．35～1．43；P=0．33），与化疗比较差异无统计学意义；EGFR—TKIs联合化疗的一线治疗与单纯化疗市目比，PFS（日R=0．69；95％CI：0．34～1．42；P=0．32）、OS（月R=1．06；95％CI：0．91—1．24；P=0．43）、ORR（RR=1．14；95％CI：0．87～1．49；P=0．34），差异无统计学意义。结论与化疗比较，作为一线用药的EGFR—TKIs无论是否联合化疗应用于非选择型晚期NSCLC患者，均不能起到有效的治疗作用。

Objective To analyze the effectiveness of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors （EGFR-TKIs） as first line compared with chemotherapy on the unselected patients. Methods Randomized controlled trials （RCT） evaluating the effectiveness of EGFR-TKIs compared with chemotherapy as first line treatment of the un- selected Non-small-cell lung cancer （NSCLC） were obtained from PubMed, the Cochrane Library and EMBASE. All literatures were assessed by the inclusion and exclusion criteria, quality assessment and data abstraction. The Meta analysis was performed by RevMan 5.3.5 and STATA 12.0 software and was contrasted in EGFR TKIs - treatment of the unselected NSCLC patients curative effect. The stability and reliability were evaluated by sensitivity analysis and publication bias analysis. Results A total of 7 trials with 2612 patients were included in the Meta-analysis. The PFS （HR=I.18; 95%CI： 0.96-1.45; P=-0.12）, OS （HR=l.24; 95%CI： 0.97-1.57; P=0.08） and the ORR （RR=0.71; 95%CI： 0.35- 1.43; P=0.33） of the unselected patients in the EGFR-TKI group and the chemotherapy group as first -line treatment did not significantly differ. Likewise, the PFS （HR=0.69; 95%CI： 0.34-1.42; P=0.32） ,OS （HR=I.06; 95%CI： 0.91-1.24; P=0.43） and the ORR （RR=I.14; 95%CI： 0.87-1.49; P=0.34） of the unselected patients in the EGFR-TKIs in combi- nation of chemotherapy group and the chemotherapy group did not significant difference. Conclusion Compared with chemotherapy, unselected advanced NSCLC patients, first -line EGFR-TKIs treatment all hadn＇t effective treatment effect.