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瑞戈非尼用于难治性转移性结直肠癌安全性和有效性的荟萃分析。

A meta-analysis of safety and efficacy of regorafenib for refractory metastatic colorectal cancer.

作者信息

Xue Wu-Song, Men Si-Ye, Liu Wei, Liu Reng-Hai

机构信息

Department of Anorectal Surgery.

Department of General Surgery, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.

出版信息

Medicine (Baltimore). 2018 Oct;97(40):e12635. doi: 10.1097/MD.0000000000012635.

Abstract

BACKGROUND

Patients with metastatic colorectal cancer (mCRC) often suffer from progressive disease despite previous therapy. It has been a great challenge for those patients. In 2012, regorafenib was approved for mCRC. In this meta-analysis, we aimed to collect and present existing data to explorethe clinical use of regorafenib.

METHODS

The online electronic databases, such as PubMed, Embase, and the Cochrane library, updated to November 2017 were systematically searched. Trials on the effectiveness of regorafenib in patients who suffer from treatment-refractory metastatic colorectal cancer were included, of which the main outcomes included 3 parameters: overall survival (OS), progression-free survival (PFS), and grade 3/4 AE.

RESULTS

Totally, 4 trials were included in this meta-analysis. The OD was significantly better with the use of regorafenib (OR = 0.78, 95%CI = 0.65-0.94, I = 69%, P = .008), and PFS (OR = 0.52, 95%CI = 0.34-0.79, I = 97%, P = .002). However, the most common toxicities occurred more frequently in the regorafenib group than the control group (OR = 3.73, 95%CI = 1.68-8.28, I = 79%, P = .001).

CONCLUSION

Regorafenib demonstrates better efficacy and has manageable adverse-event profile for treatment-refractory mCRC. Considering the safety feature of regorafenib, further studies and clinical trials are warranted to investigate the dosing of regorafenib and alternative approaches are needed to explore predictive biomarker fortherapy selection.

摘要

背景

转移性结直肠癌(mCRC)患者尽管接受了前期治疗,但仍常出现疾病进展。这对这些患者来说一直是巨大的挑战。2012年,瑞戈非尼被批准用于治疗mCRC。在这项荟萃分析中,我们旨在收集并呈现现有数据,以探索瑞戈非尼的临床应用。

方法

系统检索了截至2017年11月更新的在线电子数据库,如PubMed、Embase和Cochrane图书馆。纳入了关于瑞戈非尼对难治性转移性结直肠癌患者有效性的试验,其中主要结局包括3个参数:总生存期(OS)、无进展生存期(PFS)和3/4级不良事件。

结果

本荟萃分析共纳入4项试验。使用瑞戈非尼时总生存期显著更好(OR = 0.78,95%CI = 0.65 - 0.94,I = 69%,P = 0.008),无进展生存期也更好(OR = 0.52,95%CI = 0.34 - 0.79,I = 97%,P = 0.002)。然而,最常见的毒性反应在瑞戈非尼组比对照组更频繁出现(OR = 3.73,95%CI = 1.68 - 8.28,I = 79%,P = 0.001)。

结论

瑞戈非尼对难治性mCRC显示出更好的疗效,且不良事件可控。考虑到瑞戈非尼的安全性特征,有必要进行进一步的研究和临床试验来探究瑞戈非尼的给药剂量,并且需要探索替代方法以寻找治疗选择的预测生物标志物。

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