瑞戈非尼治疗转移性结直肠癌回顾性系列研究的系统评价与荟萃分析

A Systematic Review and Meta-analysis of Retrospective Series of Regorafenib for Treatment of Metastatic Colorectal Cancer.

作者信息

Mercier Joey, Voutsadakis Ioannis A

机构信息

Northern Ontario School of Medicine, Sudbury, ON, Canada.

Northern Ontario School of Medicine, Sudbury, ON, Canada

出版信息

Anticancer Res. 2017 Nov;37(11):5925-5934. doi: 10.21873/anticanres.12039.

DOI:10.21873/anticanres.12039

PMID:29061771

Abstract

BACKGROUND

Metastatic colorectal cancer is a common disease encountered in oncology practice and treatment options beyond fluoropyrimidines, irinotecan, oxaliplatin and monoclonal antibodies against epidermal growth factor receptor and vascular endothelium growth factor (VEGF) are limited. Regorafenib, a new drug that targets tyrosine kinases such as VEGF receptor as well as others, has been added recently to the armamentarium for metastatic colorectal cancer. This report analyzes the published experience with this drug in clinical practice outside of clinical trials.

MATERIALS AND METHODS

A literature search of major databases was performed for the identification of studies of regorafenib in metastatic colorectal cancer. Studies retained for further analysis were in English or French, describing 20 or more patients treated with regorafenib monotherapy and not part of a phase I, II or III trial. Results of the pooled analysis of retrospective studies were compared with results of the published phase III trials and a phase IIIb prospective study.

RESULTS

Twelve publications including a total of 702 patients were included in the meta-analysis. Summary response rate was 2% [95% confidence interval (CI) =0.8-3.2%] and the disease control rate 38.14% (95% CI=32.35-43.93%). Summary survival rates were 3.34 months (95% CI=2.71-3.97 months) for progression-free and 7.27 months (95% CI=6.23-8.3 months) for overall survival. These were similar to the phase III and IIIb studies. Most common adverse effects were also consistent with those of the published phase III experience.

CONCLUSION

This systematic review and meta-analysis confirmed a moderate efficacy of regorafenib in later-stage metastatic colorectal cancer in the everyday clinical practice setting outside of clinical trials. Future identification of biomarkers may aid in further tailoring of this treatment in order to obtain maximum clinical benefit.

摘要

背景

转移性结直肠癌是肿瘤学实践中常见的疾病，除氟尿嘧啶、伊立替康、奥沙利铂以及针对表皮生长因子受体和血管内皮生长因子（VEGF）的单克隆抗体外，治疗选择有限。瑞戈非尼是一种靶向VEGF受体等多种酪氨酸激酶的新药，最近已被纳入转移性结直肠癌的治疗药物库。本报告分析了该药物在临床试验之外的临床实践中的已发表经验。

材料与方法

对主要数据库进行文献检索，以确定瑞戈非尼治疗转移性结直肠癌的研究。保留用于进一步分析的研究需为英文或法文，描述20例或更多接受瑞戈非尼单药治疗的患者，且不属于I期、II期或III期试验。将回顾性研究的汇总分析结果与已发表的III期试验和IIIb期前瞻性研究结果进行比较。

结果

荟萃分析纳入了12篇出版物，共702例患者。总缓解率为2%[95%置信区间（CI）=0.8 - 3.2%]，疾病控制率为38.14%（95%CI = 32.35 - 43.93%）。无进展生存期的总生存率为3.34个月（95%CI = 2.71 - 3.97个月），总生存期为7.27个月（95%CI = 6.23 - 8.3个月）。这些结果与III期和IIIb期研究相似。最常见的不良反应也与已发表的III期经验一致。