化疗间插联合EGFR-TKIs对比单独化疗一线治疗晚期非小细胞肺癌的Meta分析

发布时间：2018-10-17 17:20

【摘要】：目的:化疗与表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor-tyrosine kinase inhibitors,EGFR-TKIs)联合疗法一直是许多研究的焦点,其中间插联合疗法受到了更多研究者的关注。本研究旨在系统评价化疗与EGFR-TKIs间插联合疗法对比单独化疗一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:检索The Cochrane Library、Pub Med、EMBASE、中国生物医学文献数据库(CBM)、知网和万方等数据库关于化疗间插联合EGFR-TKIs疗法对比单独化疗一线治疗晚期NSCLC的随机对照试验(randomized controlled trial,RCT),分析如下结局指标:无进展生存期(progression free survival,PFS)、总体生存期(overall survival,OS)、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)以及不良反应发生率。由两名研究者根据Cochrane系统评价手册筛选文献、进行质量评价以及提取并交叉核对数据。应用Stata12.0软件进行meta分析。结果:本研究共纳入6个RCT,共计933例晚期NSCLC患者。Meta分析结果表明,在晚期NSCLC患者一线治疗中,与单独化疗相比,间插联合疗法虽然延长了患者的PFS(HR=0.72,95%CI=0.53-0.98,P=0.037),但并不能提高其OS(HR=0.85,95%CI=0.72-1.01,P=0.060)、ORR(OR=1.59,95%CI=0.86-2.95,P=0.142)和DCR(OR=1.09,95%CI=0.95-1.25,P=0.226)。进一步的亚组分析发现,间插联合疗法显著提高了女性、腺癌、从不吸烟和EGFR突变等患者的PFS,差异具有统计学意义。在安全性方面,间插联合疗法的主要不良反应为皮疹(OR=7.81,95%CI=3.74-16.34,P=0.000)和腹泻(OR=2.73,95%CI=1.92-3.89,P=0.000)。结论:一线接受化疗间插联合EGFR-TKIs治疗的NSCLC患者的PFS明显高于接受单独化疗者,其主要不良事件是皮疹和腹泻。因此,间插联合治疗具有一定优势,但仍需要更多大样本、高质量的RCT进一步验证。
[Abstract]:Objective: chemotherapy combined with epidermal growth factor receptor tyrosine kinase inhibitor (epidermal growth factor receptor-tyrosine kinase inhibitors,EGFR-TKIs) has been the focus of many studies. The purpose of this study was to evaluate the efficacy and safety of chemotherapy and EGFR-TKIs interventional therapy in the treatment of advanced non-small cell lung cancer (non-small cell lung cancer,NSCLC). Methods: a randomized controlled trial (randomized controlled trial,RCT) of The Cochrane Library,Pub Med,EMBASE, Chinese biomedical literature database, (CBM), Zhiwang and Wanfang, on the comparison of chemotherapeutic interventional therapy with EGFR-TKIs therapy in late stage NSCLC was conducted. The results were analyzed as follows. Outcome measures: progression-free survival (progression free survival,PFS), total survival (overall survival,OS), objective remission rate (objective response rate,ORR), disease control rate (disease control rate,DCR) and adverse reactions. According to the Cochrane system evaluation manual, two researchers sifted the literature, evaluated the quality, extracted and cross-checked the data. Meta analysis was carried out with Stata12.0 software. Results: in this study, 933 patients with advanced NSCLC were included in 6 RCT, patients. The results of Meta analysis showed that in the first-line treatment of advanced NSCLC patients, the intercalation combined therapy could not improve the OS (HR=0.85,95%CI=0.72-1.01,P=0.060), ORR (OR=1.59,95%CI=0.86-2.95,P=0.142) and DCR (OR=1.09,95%CI=0.95-1.25,P=0.226), although it prolonged the PFS (HR=0.72,95%CI=0.53-0.98,P=0.037) of the patients compared with chemotherapy alone. Further subgroup analysis showed that interventional therapy significantly increased PFS, in women, adenocarcinoma, non-smoking and EGFR mutation. In terms of safety, the main adverse effects of interventional therapy were skin rash (OR=7.81,95%CI=3.74-16.34,P=0.000) and diarrhea (OR=2.73,95%CI=1.92-3.89,P=0.000). Conclusion: the PFS of NSCLC patients treated with interventional chemotherapy plus EGFR-TKIs was significantly higher than that of patients treated with chemotherapy alone. The main adverse events were rash and diarrhea. Therefore, interventional therapy has some advantages, but still needs more large samples, high quality RCT further verification.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2

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