厄洛替尼治疗晚期非小细胞肺癌的系统评价

A Systematic Review of Erlotinib for Advanced Non-small Cell Lung Cancer

背景与目的晚期非小细胞肺癌患者是否可以从厄洛替尼治疗中获益尚不确定,本文拟系统评价厄洛替尼治疗晚期非小细胞肺癌的有效性及安全性。方法计算机检索VIP、CBM、CNKI、PubMed、EMBASE、The Cochrane Library等数据库,同时追查纳入文献的参考文献并且联系本领域专家、通讯作者,以获取以上检索尚未发现的相关信息。按纳入排除标准纳入厄洛替尼治疗晚期非小细胞肺癌的随机对照试验并对其进行质量评价,采用Cochrane协作网提供RevMan 5.0统计软件进行meta分析。结果共纳入3个随机对照试验(2969名病例),meta分析结果表明,与安慰剂相比,厄洛替尼可提高患者1年生存率(OR=1.18,95%CI:1.01-1.38)和肿瘤反应率(OR=1.24,95%CI:1.03-1.49),延长中位生存期、疾病无进展期、肿瘤反应持续时间,同时增加3-4级皮疹(OR=16.33,95%CI:7.01-38.02)和腹泻(OR=5.02,95%CI:2.93-8.60)的发生率。结论晚期非小细胞肺癌患者可以从厄洛替尼治疗中获益,但皮疹发生率和腹泻发生率明显增加,而在血液系统损害、严重肝肾损害、心脏毒性等方面与安慰剂没有差异。

Background and objective Erlotinib is a new and efficient anti-tumor targeted therapy drug, and it has been used in China for non-small cell lung cancer since 2006. The aim of this study is to review the effectiveness and safety of erlotinib for treating advanced non-small cell lung cancer. Methods Authors searched the Cochrane Library, Pubmed, Embase, CBM, CNKI and Wanfang Date. The randomized controlled trials （RCTs） were analyzed by RevMan 4.2 software. Authors also included retrospective case report published in Chinese journals. Results Four RCTs and 8 uncontrolled case reports were analyzed. The results of the RCTs showed that erlotinib was significantly better than placebo on progression-free survival, median survival time, response rate （OR=10.21, 95%CI： 2.44-42.73） and 1-yr survival rate （OR=1.67, 95%CI： 1.13-2.46）; Erlotinib was superior than paclitaxel＋carboplatin on median survival time （HR=1.73, 95%CI： 1.09-2.73; P=0.018）, the other efficacy were similar; The efficacy of erlotinib combined chemotherapy was close to chemotherapy alone. The main side effects caused by erlotinib were rash and diarrhea, and the tolerance was well. The overall uncontrolled clinical studies showed that the response rate was 27.27%, and the 1-yr survival rate was 56.1%. Conclusion Erlotinib is effect for non-small cell lung cancer, and maybe better for never smokers, female, Asia and adenocarcima. The clinical favor from erlotinib combined chemotherapy remains uncertain. But the effect of erlotinib being used in clinical settings needs to be confirmed by further large and multicenter.