表皮生长因子受体酪氨酸激酶抑制剂对比单药化疗二线治疗晚期非小细胞肺癌疗效的Meta分析  

Comparison of the efficacy of EGFR tyrosine kinase inhibitor monotherapy with standard secone- line chemotherapy in previously treated advanced non- small cell lung cancer: A Meta- analysis

作　　者：钱晓涛[1,2] 祝桂琦 何圆[1] 赵腊梅[2] 尤长宣[1] 

机构地区：[1]南方医科大学南方医院肿瘤科,广东广州510515 [2]阜阳市第五人民医院内科,安徽阜阳236000 [3]温州医科大学第一临床医学院,浙江温州325000

出　　处：《现代肿瘤医学》2015年第4期483-490,共8页Journal of Modern Oncology

基　　金：广东省科技项目(编号:2012B031800394);广东省自然科学基金项目(编号:S2011010003881)

摘　　要：目的:利用Meta分析比较表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)与单药二线治疗晚期非小细胞肺癌(NSCLC)的临床疗效。方法:在Pub Med、EMBASE、中国生物医学文献、CNKI、维普、万方等数据库中检索1965年1月至2014年4月发表的相关文献。制定纳入标准对文献进行筛选以保证纳入研究的同质性。由2名评价者独立评价所纳入研究的质量,提取资料并交叉核对。符合标准的研究采用Stata 12.0软件进行Meta分析。以客观缓解率(ORR)选择比值比(OR)作为效应尺度指标,计算无进展生存时间(PFS)和总生存时间(OS)风险比(HR),同时计算95%可信区间(CI)。结果:17个随机对照实验符合全部纳入标准,含4514例NSCLC患者。Meta分析显示,接受靶向治疗和化疗组的PFS(HR 0.94,95%CI=0.79-1.12,P=0.511)、OS(HR 0.98,95%CI=0.89-1.08,P=0.699)无显著统计学差异。在EGFR基因状态未知人群中,靶向治疗ORR好于化疗(OR 1.53,95%CI=1.02-2.31,P=0.040)。同时对于EGFR基因状态的野生人群,靶向治疗OS好于化疗(HR 0.75,95%CI=0.57-0.99,P=0.044)。结论:对于EGFR基因状态未知人群,靶向治疗和化疗组的PFS、OS无显著统计学差异,而靶向治疗缓解率ORR好于化疗。Objective： To use Meta - analysis to compare the clinical efficacy between epidermal growth factor re- ceptor inhibitors（ EGFR - TKI） and second - line chemotherapy with single drug for advanced non - small cell lung cancer（NSCLC）. Methods ： Relevant literatures were searched through PubMed, Embase, CBMdise, CNKI, Wanfang and WP databases from January 1965 to April 2014. The implement standards for literature selection were used to en- sure the homogeneity of research. Two reviewers evaluated independently the quality of the included studies and then extracted the data. We performed Meta - analysis by Stata 12.0 software. Odds ratios （ORs） as efficacy index was chosen by objective response rate（ORR）, and hazard ratios（HRs） were calculated by progression- free survival （PFS） and overall survival（OS） times. The 95 % confidence interval （ CI ） was calculated simultaneously. Results ： Seventeen randomized controlled trials were included for a total of 4514 patients with NSCLC. This Meta- analysisshowed no statistical significance in PFS （ HR 0.94,95 % CI = 0.79 - 1.12, P = 0.511 ） and OS （ HR 0.98,95 % CI = 0.89 - 1.08, P = 0.699） for patients who received EGFR - TKI compared with patients who received chemotherapy. However,EGFR-TKI showed superior to chemotherapy significantly in ORR（OR 1.53,95% CI = 1.02 -2.31 ,P = 0. 040） for patients with unknown - type EGFR tumors. Similarly, there was also a significant benefit for EGFR -TKI in OS （ HR 0.75,95 % CI = 0.57 - 0.99, P = 0. 044 ） for patients with wild - type EGFR tumors. Conclusion： For pa- tients with unknown -type EGFR tumors, it showed no profound significant differences in efficacy between EGFR - TKI and chemotherapy in both PFS and OS,whereas a statistical significance can be achieved in ORR,which showed that EGFR - TKI was superior to single chemotherapy.

关 键 词：EGFR-TKI 非小细胞肺癌 单药化疗 META分析 

分 类 号：R734.2[医药卫生—肿瘤]