厄洛替尼治疗晚期非小细胞肺癌的系统评价

Pooled Analysis of the Trials of Erlotinib Monotherapy for Epidermal Growth Factor Receptor (EGFR)-mutant Advanced Non-small Cell Lung Cancer

背景与目的厄洛替尼被全球多个国家批准用于晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的二、三线治疗。有报道显示EGFR突变的患者应用厄洛替尼治疗疗效更好。本文拟探讨厄洛替尼单药治疗EGFR突变晚期NSCLC患者的疗效。方法计算机检索MEDLINE(2004-2009)、CBMdic(2004-2008)、CNKI(2004-2008),互联网检索以及纳入试验的参考文献。纳入相关临床试验,提取并汇总试验结果。结果共纳入研究7篇,包括晚期非小细胞肺癌患者463例。厄洛替尼单药治疗EGFR突变的晚期非小细胞肺癌患者,有效率达到66%,1年生存率达到73%,2年生存率达到53%,中位生存时间23个月以上,无进展生存时间8.6个月以上。结论在当前研究的基础上,厄洛替尼单药一线和二线治疗EGFR突变的晚期NSCLC有效率高,无进展生存期和总生存期长,可以推荐作为EGFR突变的晚期NSCLC的首选治疗。尚需要更详尽的证据评价厄洛替尼单药方案或厄洛替尼与化疗联合方案与标准含铂化疗方案在治疗晚期NSCLC中的地位。

Background and objective It was unclear whether advanced non-small cell lung cancer （NSCLC） patients could benefit from erlotinib therapy.This study was aimed to evaluate the efficacy and safety of NSCLC patients treated with erlotinib.Methods The relevant randomized controlled trials （RCT） were searched from VIP,CMB,CNKI,PubMed,EMBASE and The Cochrane Library.The related references and experts in this field were traced,and other authors were communicated with to obtain the information that has not been found.Quality assessment of qualified RCTs assessed by the exclusion and inclusion criteria and RevMan 5.0 provided by the Cochrane Collaboration was used to perform meta-analysis.Results Three RCTs involving 2 969 patients were included.Meta analysis results suggested that erlotinib was superior to placebo for one year survival rate （OR=1.18,95%CI：1.01-1.38）,tumor response rate （OR=1.24,95%CI：1.03-1.49）,median overall survival,median progression-free survival and tumor responses duration.At the same time,the incidence of grade 3-4 skin rash （OR=16.33,95%CI：7.01-38.02） and diarrhea （OR=5.02,95%CI：2.93-8.60） of the adverse reactions was increased.Conclusion Advanced non-small cell lung cancer patients could benefit from Erlotinib therapy,but the incidence of skin rash and diarrhea was significantly increased,and in the absence of damage to the blood system,serious liver and kidney damage,cardiac toxicity,etc,there were no difference with placebo.