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阿柏西普治疗转移性结直肠癌的安全性:基于临床和真实世界数据的文献综述与专家观点

Safety of Aflibercept in Metastatic Colorectal Cancer: A Literature Review and Expert Perspective on Clinical and Real-World Data.

作者信息

Muro Kei, Salinardi Taylor, Singh Arvind Rup, Macarulla Teresa

机构信息

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.

Global Medical Oncology, Sanofi, Boston, MA 02142, USA.

出版信息

Cancers (Basel). 2020 Mar 31;12(4):844. doi: 10.3390/cancers12040844.

Abstract

BACKGROUND

Metastatic colorectal cancer (mCRC) represents a substantial health burden globally and an increasing challenge in Asian countries. Treatment options include chemotherapy plus a vascular endothelial growth factor (VEGF) inhibitor (such as bevacizumab, aflibercept or ramucirumab), or anti-epidermal growth factor receptor (EGFR) therapies. Aflibercept, a recombinant fusion protein, has been approved for treatment of mCRC in combination with FOLFIRI for patients whose disease progresses during or after treatment with an oxaliplatin-containing regimen, based on its efficacy and tolerability profile in clinical trials. This report aims to provide an overview of both clinical and real-world evidence and experience on the use of aflibercept in routine clinical practice, with a focus on European, American and Asian populations.

METHODS

A literature search was conducted in PubMed (on 28th February 2019) using the search terms ("aflibercept") and ("Colorectal"OR"CRC") to identify publications containing information on aflibercept-containing regimens.

RESULTS

The adverse events (AE) profile was similar between geographical locations. Across trials, real-world and retrospective studies, grade ≥ 3 hypertension and proteinuria were amongst the most frequently reported AEs.

CONCLUSIONS

The safety profile of aflibercept is generally manageable and comparable across various geographic locations.

摘要

背景

转移性结直肠癌(mCRC)在全球范围内构成了沉重的健康负担,在亚洲国家也是日益严峻的挑战。治疗选择包括化疗加血管内皮生长因子(VEGF)抑制剂(如贝伐单抗、阿柏西普或雷莫西尤单抗),或抗表皮生长因子受体(EGFR)疗法。阿柏西普是一种重组融合蛋白,基于其在临床试验中的疗效和耐受性,已被批准与FOLFIRI联合用于治疗在含奥沙利铂方案治疗期间或之后疾病进展的mCRC患者。本报告旨在概述阿柏西普在常规临床实践中的临床和真实世界证据及经验,重点关注欧洲、美国和亚洲人群。

方法

于2019年2月28日在PubMed上进行文献检索,使用检索词(“阿柏西普”)和(“结直肠癌”或“CRC”)来识别包含阿柏西普治疗方案信息的出版物。

结果

不同地理位置的不良事件(AE)情况相似。在各项试验、真实世界研究和回顾性研究中,≥3级高血压和蛋白尿是最常报告的AE。

结论

阿柏西普的安全性总体上易于管理,且在不同地理位置具有可比性。

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