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吉西他滨和培美曲塞作为晚期非小细胞肺癌维持治疗的作用:一项随机对照试验的系统评价和荟萃分析

Role of Gemcitabine and Pemetrexed as Maintenance Therapy in Advanced NSCLC: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Hu Xingsheng, Pu Ke, Feng Xuqin, Wen Shimin, Fu Xi, Guo Cuihua, He Wenwu

机构信息

Department of Oncology, Nanchong Central Hospital (The Second Clinical College of North Sichuan Medical College), Nanchong, China.

DaZhou College of Chinese Medicine, DaZhou, China.

出版信息

PLoS One. 2016 Mar 8;11(3):e0149247. doi: 10.1371/journal.pone.0149247. eCollection 2016.

Abstract

BACKGROUND

Gemcitabine and pemetrexed have been used as maintenance therapy. However, few systematic reviews and meta-analyses have assessed their effects in the newest studies. This systematic review and meta-analysis were conducted to assess the role of gemcitabine and pemetrexed in the maintenance treatment of non-small-cell lung carcinoma (NSCLC).

METHODS

We performed a literature search using PubMed, EMBASE and Cochrane library databases from their inceptions to September 16, 2015. We also searched the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), and National Comprehensive Cancer Network (NCCN) databases from 2008 to 2015. Two authors independently extracted the data. The Cochrane Collaboration's risk of bias graph was used to assess the risk of bias. The GRADE system was used to assess the grading of evidence, and a meta-analysis was conducted using Stata 11.0 software.

RESULTS

Eleven randomized controlled trial (RCT) studies were collected. Ten studies were included in the meta-analysis and divided into the following 4 groups: gemcitabine vs. best supportive care (BSC)/observation, pemetrexed vs. BSC/placebo, pemetrexed + bevacizumab vs. bevacizumab and pemetrexed vs. bevacizumab. Gemcitabine exhibited significantly improved progression-free survival (PFS) compared with BSC (hazard ratio (HR) = 0.62, p = 0.000). Pemetrexed exhibited significantly improved PFS (HR = 0.54, p = 0.000) and OS (HR = 0.75, p = 0.000) compared with BSC. Pemetrexed + bevacizumab almost exhibited significantly improved PFS (HR = 0.71, p = 0.051) compared with bevacizumab. Pemetrexed exhibited no improvement in PFS or overall survival (OS) compared with bevacizumab. Regarding the grade, the GRADE system indicated that the gemcitabine group was "MODERATE", the pemetrexed group was "HIGH", and both the pemetrexed + bevacizumab vs. bevacizumab groups and pemetrexed vs. B groups were "LOW".

CONCLUSIONS

Gemcitabine or pemetrexed compared with BSC/observation/placebo significantly improved PFS or OS. Whether pemetrexed + bevacizumab compared with bevacizumab alone significantly improves PFS requires further investigation.

摘要

背景

吉西他滨和培美曲塞已被用作维持治疗。然而,很少有系统评价和荟萃分析评估它们在最新研究中的效果。本系统评价和荟萃分析旨在评估吉西他滨和培美曲塞在非小细胞肺癌(NSCLC)维持治疗中的作用。

方法

我们使用PubMed、EMBASE和Cochrane图书馆数据库从建库至2015年9月16日进行文献检索。我们还检索了2008年至2015年美国临床肿瘤学会(ASCO)、欧洲医学肿瘤学会(ESMO)和美国国立综合癌症网络(NCCN)数据库。两名作者独立提取数据。使用Cochrane协作网的偏倚风险图评估偏倚风险。采用GRADE系统评估证据等级,并使用Stata 11.0软件进行荟萃分析。

结果

收集到11项随机对照试验(RCT)研究。10项研究纳入荟萃分析并分为以下4组:吉西他滨对比最佳支持治疗(BSC)/观察,培美曲塞对比BSC/安慰剂,培美曲塞+贝伐单抗对比贝伐单抗,以及培美曲塞对比贝伐单抗。与BSC相比,吉西他滨显著改善无进展生存期(PFS)(风险比(HR)=0.62,p=0.000)。与BSC相比,培美曲塞显著改善PFS(HR=0.54,p=0.000)和总生存期(OS)(HR=0.75,p=0.000)。与贝伐单抗相比,培美曲塞+贝伐单抗几乎显著改善PFS(HR=0.71,p=0.051)。与贝伐单抗相比,培美曲塞在PFS或总生存期(OS)方面无改善。关于证据等级,GRADE系统表明吉西他滨组为“中等”,培美曲塞组为“高”,培美曲塞+贝伐单抗对比贝伐单抗组和培美曲塞对比贝伐单抗组均为“低”。

结论

与BSC/观察/安慰剂相比,吉西他滨或培美曲塞显著改善PFS或OS。培美曲塞+贝伐单抗与单独使用贝伐单抗相比是否能显著改善PFS需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e27/4783083/992ce0947d6a/pone.0149247.g001.jpg

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