摘要
目的：系统评价厄洛替尼维持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、Web of science、EMbase、PubMed、CBM、CNKI和万方数据,收集厄洛替尼维持治疗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,评价文献质量,采用RevMan5.1进行荟萃分析。结果：最终纳入4个临床随机对照试验,共3 046例患者。厄洛替尼维持治疗可延长晚期NSCLC患者的无进展生存期（progression-free survival,PFS）,HR=0.70,95%CI为0.63～0.77,P〈0.001。亚组分析结果显示,在任何性别（男或女）、病理类型（鳞癌或腺癌）、吸烟状况（吸烟与不吸烟）及免疫组化EGFR表达阳性的患者可获益,HR=0.73,95%CI为0.63～0.85,P〈0.001。厄洛替尼维持治疗可延长患者的总生存期（overall survival,OS）,HR=0.90,95%CI为0.82～0.98,P=0.01;亚组分析结果显示,在女性（HR=0.75,95%CI为0.61～0.92,P=0.006）、腺癌（HR=0.84,95%CI为0.73～0.96,P=0.01）和不吸烟（HR=0.65,95%CI为0.49～0.86,P=0.002）的患者可获益。安全性方面,厄洛替尼维持治疗最主要的不良反应为皮疹（RR=22.51,95%CI为7.31～71.01,P〈0.001）和腹泻（RR=3.18,95%CI为1.65～6.14,P〈0.001）;在贫血、中性粒细胞减少和间质性肺炎方面,2组差异均无统计学意义。结论：厄洛替尼维持治疗能延长晚期NSCLC患者的PFS和OS,且女性、腺癌、不吸烟和免疫组化EGFR表达阳性的患者是选择的优势人群。最主要的不良反应为皮疹和腹泻,毒副作用低可耐受。
OBJECTIVE：To systematically evaluate the efficacy and safety of erlotinib as maintenance therapy in patients with unresectable non-small cell lung cancer（NSCLC）.METHODS：We searched The Cochrane Library,web of science,EMbase,PubMed,CBM,CNKI and Wanfang data.Data analyses were conducted using RevMan 5.1software.RESULTS：The final analysis included four trials,covering 3 046patients.The results Meta-analyses showed the erlotinib significantly increased progression-free survival（PFS,HR=0.70,95%CI：0.63-0.77,P〈0.001）and overall survival（HR=0.90,95%CI：0.82-0.98,P=0.01）compared with placebo or observation.The PFS benefit was consistent in all subgroups including sex,smoking status,pathological types,EGFR immunohistochemistry-positive（HR=0.73,95%CI： 0.63-0.85,P〈0.001）.Overall survival benefit was observed in patients with clinical features such as female（HR= 0.75,95%CI：0.61-0.92,P=0.006）,adenocarcinoma（HR=0.84,95%CI：0.73-0.96,P=0.01）,non-smoker（HR= 0.65,95%CI：0.49-0.86,P=0.002.The main adverse reactions were rashes（RR=22.51,95%CI：7.31-71.01,P 0.001）and diarrhea（RR=3.18,95%CI：1.65-6.14,P〈0.001）.In anemia,and neutropenia,interstitial pneumonia,the difference between the two groups had no statistical significance.CONCLUSIONS：The results show that maintenance therapy with erlotinib produces a significant PFS and OS benefit for unselected patients with advanced NSCLC compared with placebo or observation,and may be better for female,non-smoker,and EGFR immunohistochemistry-positive and adenocarcinoma.The main adverse reactions were diarrhea and rashes,low toxicity can be tolerated.
出处
《中华肿瘤防治杂志》
CAS
北大核心
2014年第10期786-791,共6页
Chinese Journal of Cancer Prevention and Treatment
关键词
肺癌
非小细胞肺癌
厄洛替尼
维持治疗
随机对照试验
系统评价
lung cancer
non-small cell lung cancer
erlotinib
maintenance therapy
randomized controlled clinical study
systematic review
