厄洛替尼与化疗二线治疗晚期非小细胞肺癌疗效Meta分析

Efficacy of erlotinib versus chemotherapy in the second-line therapy of advanced non-small cell lung cancer:A Meta-analysis

目的系统评价厄洛替尼与化疗二线治疗晚期非小细胞肺癌（non-small cell lung cancer,NSCLC）的有效性及安全性。方法计算机检索The Cochrane Library（2014年第7期）、Web of Science（1966-2014-07）、EMbase（1900-2014-07）、PubMed（1966-2014-07）、CBM（1978-2014-07）、CNKI（1994-2014-07）和WanFang Data（1989-2014-07）,收集厄洛替尼二线治疗晚期NSCLC的临床随机对照试验,2名评价员按照纳入与排除标准筛选文献、提取资料及评价文献质量后,采用RevMan5.2进行荟萃分析。结果最终纳入6个临床随机对照试验,共1 369例患者。荟萃分析结果显示,厄洛替尼与传统化疗相比二线治疗晚期NSCLC患者的无进展生存期（progression-free survival,PFS）（HR=0.98,95%CI为0.86~1.12,P=0.77）和总生存期（overall survival,OS）（HR=0.93,95%CI为0.81~1.07,P=0.31）差异均无统计学意义;亚组分析显示,厄洛替尼与传统化疗在吸烟状况、性别及表皮生长因子受体（epidermal growth factor recepptor,EGFR）野生型患者中PFS和OS差异均无统计学意义;厄洛替尼联合化疗与单纯化疗相比可延长非鳞癌患者的PFS（HR=0.61,95%CI为0.47~0.79,P=0.000 2）和OS（HR=0.71,95%CI为0.54~0.94,P=0.02）。安全性方面,厄洛替尼最主要的不良反应为皮疹和腹泻,与化疗联合使用耐受性良好。结论厄洛替尼对比化疗二线治疗NSCLC在PFS和OS方面并未显示出优势,对于晚期非鳞癌患者来说,厄洛替尼联合化疗可明显延长患者的PFS和OS,厄洛替尼最主要的不良反应为皮疹和腹泻,与化疗联合使用耐受性良好。

OBJECTIVE To systematically evaluate the efficacy and safety of erlotinib versus chemotherapy as sec- ond-line treatment in patients with advanced non-small cell lung cancer （NSCLC）. METHODS We searched the Cochrane Library（Issue 7,2014）, Web of Science（1966-- 2014-07）, EMbase（1900-- 2014-07）, PubMed （1966-- 2014-07）, CBM （1978--2014-07） ,CNKI（1994--2014-07） and WanFang Data（1989--2014-07）. Data Analyses was conducted using Rev- Man5.2 software. RESULTS The final analysis included six trials,covering 1 396 patients. The results of recta-analyses showed that： erlotinib was not significantly improved progression-free survival （PFS） [HR=0.98,95 %CI（0.86--1.12）, P= 0.77] and overall survival（OS） [HR= 0.93,95 % CI（0.81 -- 1.07） ,P= 0.31） ]compared with chemotherapy, subgroup analysis showed the PFS and OS in two groups had no significant difference in smoking state and gender as well as in pa- tients with wild-type EGFR~ However, compared with chemotherapy group, erlotinib combined with chemotherapy signifi- cantly improved PFS[HR=0. 61,95% CI（0.47--0.79）,P=0.000 2] and OS[HR=0.71,95%CI（0.54--0.94）,P= 0. 02）] in second--line non-squamous non-small cell lung cancer. The main adverse reactions caused by erlotinib were tol erable rash and diarrhea. CONCLUSIONS Erlotinib monotherapy in second-line treatment of non-small cell lung cancer did not show superiority, erlotinib in combination with chemotherapy for advanced non-squamous non-small cell lung canc- er prolongs the patienCs PFS and OS. The main adverse reactions caused by erlotinib were tolerable rash and diarrhea.