表皮生长因子受体酪氨酸激酶抑制剂与紫杉烷类药物治疗非小细胞肺癌患者的疗效比较：一项遵循PRISMA规范的系统评价及Meta分析与Meta回归分析

EGFR-TKIs versus taxanes agents in therapy for nonsmall-cell lung cancer patients: A PRISMA-compliant systematic review with meta-analysis and meta-regression.

作者信息

An Na, Zhang Yingshi, Niu Huibin, Li Zuojing, Cai Jiayi, Zhao Qingchun, Li Qing

机构信息

School of Life Sciences and Biopharmaceutis, Shenyang Pharmaceutical University Department of Pharmacy, General Hospital of Shenyang Military Area Command School of Pharmacy School of Medical Apparatus and Instruments, Shenyang Pharmaceutical University, Shenyang, P.R. China.

出版信息

Medicine (Baltimore). 2016 Dec;95(50):e5601. doi: 10.1097/MD.0000000000005601.

DOI:10.1097/MD.0000000000005601

PMID:27977598

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5268044/

Abstract

BACKGROUND

Currently, the nonsmall-cell lung cancer (NSCLC) is a worldwide disease, which has very poor influence on life quality, whereas the therapeutic effects of drugs for it are not satisfactory. The aim of our PRISMA-compliant systematic review and meta-analysis was to compare the efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) with Taxanes in patients with lung tumors.

METHODS

We collected randomized controlled trials (RCTs) of EGFR-TKIs (gefitinib, erlotinib) versus Taxanes (docetaxel, paclitaxel) for the treatment of NSCLC by searching PubMed, EMbase, and the Cochrane library databases until April, 2016. The extracted data on progression-free survival (PFS), progression-free survival rate (PFSR), overall survival (OS), overall survival rate (OSR), objective response rate (ORR), disease control rate (DCR), quality of life (QoL), and adverse event rates (AEs) were pooled. Disease-relevant outcomes were evaluated using RevMan 5.3.5 software and STATA 13.0 software.

RESULTS

We systematically searched 26 RCTs involving 11,676 patients. The results showed that EGFR-TKIs could significantly prolong PFS (hazard ratio [HR] = 0.78, 95% confidence interval [CI]: 0.66-0.92) and PFSR (risk ratio [RR] = 2.10, 95% CI: 1.17-3.77), and improve ORR (RR = 1.62, 95% CI: 1.38-1.91) and QoL. EGFR-TKIs had similar therapeutic effects to taxanes with respect to OS (HR = 1.00, 95% CI: 0.95-1.05) and OSR (RR = 1.03, 95% CI: 0.94-1.14). Furthermore, there were no significant differences between them in DCR (RR = 0.95, 95% CI: 0.88-1.03). Finally, EGFR-TKIs were superior to taxanes in most of all grades or grade ≥3 AEs.

CONCLUSION

In the efficacy and safety evaluation, EGFR-TKIs had an advantage in the treatment of NSCLC, especially for patients with EGFR mutation-positive. The project was prospectively registered with PROSPERO database of systematic reviews, with number CRD42016038700.

摘要

背景

目前，非小细胞肺癌（NSCLC）是一种全球性疾病，对生活质量影响极差，而针对其的药物治疗效果并不令人满意。我们这项符合PRISMA标准的系统评价和荟萃分析的目的是比较表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）与紫杉烷类药物对肺肿瘤患者的疗效和安全性。

方法

通过检索PubMed、EMbase和Cochrane图书馆数据库，收集截至2016年4月EGFR-TKIs（吉非替尼、厄洛替尼）与紫杉烷类药物（多西他赛、紫杉醇）治疗NSCLC的随机对照试验（RCTs）。汇总提取的无进展生存期（PFS）、无进展生存率（PFSR）、总生存期（OS）、总生存率（OSR）、客观缓解率（ORR）、疾病控制率（DCR）、生活质量（QoL）和不良事件发生率（AEs）的数据。使用RevMan 5.3.5软件和STATA 13.0软件评估疾病相关结局。

结果

我们系统检索了26项涉及11676例患者的RCTs。结果显示，EGFR-TKIs可显著延长PFS（风险比[HR]=0.78，95%置信区间[CI]：0.66-0.92）和PFSR（风险比[RR]=2.10，95%CI：1.17-3.77），并改善ORR（RR=1.62，95%CI：1.38-1.91）和QoL。在OS（HR=1.00，95%CI：0.95-1.05）和OSR（RR=1.03，95%CI：0.94-1.14）方面，EGFR-TKIs与紫杉烷类药物具有相似的治疗效果。此外，它们在DCR方面无显著差异（RR=0.95，95%CI：0.88-1.03）。最后，在所有级别或≥3级AEs方面，EGFR-TKIs优于紫杉烷类药物。