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厄洛替尼与传统化疗治疗晚期非小细胞肺癌的疗效：一项符合PRISMA标准的系统评价及Meta回归与Meta分析

The Efficacy of Erlotinib Versus Conventional Chemotherapy for Advanced Nonsmall-Cell Lung Cancer: A PRISMA-Compliant Systematic Review With Meta-Regression and Meta-Analysis.

作者信息

Ma Hu, Tian Xu, Zeng Xian-Tao, Zhang Yu, Wang Yi, Wang Fei, Zhou Jian-Guo

机构信息

From the Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi, P.R. China (HM, YZ, YW, FW, JGZ); Center for Translational Medicine, Zunyi Medical University, Zunyi, P.R. China (JGZ, HM); Graduate College, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China (XT); School of Nursing, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China (XT); Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, P.R. China (XTZ); Center for Evidence-Based and Translational Medicine, Wuhan University, Wuhan, P.R. China (XTZ).

出版信息

Medicine (Baltimore). 2016 Jan;95(2):e2495. doi: 10.1097/MD.0000000000002495.

DOI:10.1097/MD.0000000000002495
PMID:26765461
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4718287/
Abstract

Non-small-cell lung cancer (NSCLC) is the leading cause of cancer deaths. Erlotinib is the first-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), the National Comprehensive Cancer Network (NCCN) guidelines recommend it as a first-line agent in patients with sensitizing EGFR mutations.We conducted a meta-analysis to compare the efficacy of erlotinib and chemotherapy for advanced NSCLC, and evaluated the efficacy of them to provide references for further clinical practice and research.PubMed, EMBASE, CBM, CNKI, WanFang database, The Cochrane library, and Web of Science, as well as abstracts presented at ASCO conferences and ClinicalTrials.gov were searched to identify relevant studies. HR with 95% confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS), relative risk (RR) with 95% CIs for objective response rate (ORR) and 1-year survival rate (OSR) were all extracted. If the I was ≤40%, then the trial was considered to be heterogeneous, and a fixed-effects model was selected. Otherwise, a random-effects model was used. Meta-regression and sensitivity analyses were conducted to determine the possible heterogeneity causes and to further identify the influence of the various exclusion criteria on the overall risk estimate.The pooled analysis demonstrated a PFS HR of 0.93 (95% CI = 0.73, 1.19) for erlotinib versus chemotherapy and an ORR of 18.43% versus 22.07%, respectively. The OS HR was 1.02 (95%CI = 0.93, 1.12). The HRs for PFS estimated based on 10 trials involving 1101 patients were 0.22 (95% CI = 0.15, 0.29) and 1.27 (95% CI = 1.04, 1.48) in EGFR mutation-type and wild-type patients, respectively. The HRs for OS calculated from 4 studies including 681 participants were 0.83 (95% CI = 0.61, 1.05) and 0.86 (95% CI = 0.68, 1.04) in EGFR mutation-type and wild-type patients, respectively. The 1-year survival rates were 31.31% and 32.41%, respectively.Overall, the present meta-analysis suggested that erlotinib did not improve the ORR, PFS, OS or the 1-year survival rate for whole patients. However, erlotinib could benefit patients with EGFR mutation in terms of PFS, but the OS does not benefit from it for these patients. Further studies of erlotinib for these subgroup patients are warranted.

摘要

非小细胞肺癌（NSCLC）是癌症死亡的主要原因。厄洛替尼是第一代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs），美国国立综合癌症网络（NCCN）指南推荐其作为具有敏感EGFR突变患者的一线用药。我们进行了一项荟萃分析，以比较厄洛替尼与化疗治疗晚期NSCLC的疗效，并评估二者的疗效，为进一步的临床实践和研究提供参考。检索了PubMed、EMBASE、CBM、CNKI、万方数据库、考克兰图书馆和Web of Science，以及美国临床肿瘤学会（ASCO）会议上发表的摘要和ClinicalTrials.gov，以识别相关研究。提取无进展生存期（PFS）和总生存期（OS）的风险比（HR）及95%置信区间（CI），客观缓解率（ORR）和1年生存率（OSR）的相对危险度（RR）及95%CI。若I²≤40%，则认为试验具有同质性，选择固定效应模型。否则，使用随机效应模型。进行荟萃回归和敏感性分析，以确定可能的异质性原因，并进一步确定各种排除标准对总体风险估计的影响。汇总分析显示，厄洛替尼与化疗相比，PFS的HR为0.93（95%CI=0.7,1.19），ORR分别为18.43%和22.07%。OS的HR为1.02（95%CI=0.93,1.12）。基于10项涉及1101例患者的试验估计，EGFR突变型和野生型患者PFS的HR分别为0.22（95%CI=0.15,0.29）和1.27（95%CI=1.04,1.48）。根据4项包括681名参与者的研究计算，EGFR突变型和野生型患者OS的HR分别为0.83（95%CI=0.61,1.05）和0.86（95%CI=0.68,1.04）。1年生存率分别为31.31%和32.41%。总体而言，本荟萃分析表明，厄洛替尼并未提高所有患者的ORR、PFS、OS或1年生存率。然而，厄洛替尼在PFS方面可使EGFR突变患者获益，但这些患者的OS并未从中获益。有必要对这些亚组患者进一步研究厄洛替尼。

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