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Clinical Drug Investigation
Published in: Clinical Drug Investigation 11/2013

01-11-2013 | Systematic Review

Safety of Bevacizumab in Treating Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis of All Randomized Clinical Trials

Authors: Fei Dai, Lixing Shu, Yangfang Bian, Zhuo Wang, Zhangwei Yang, Wengong Chu, Shen Gao

Published in: Clinical Drug Investigation | Issue 11/2013

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Abstract

Background and objective

The incidence rates of colorectal cancer (CRC) are increasing in a number of different regions, and recent studies have indicated that addition of bevacizumab to CRC therapy is beneficial. To better understand the relative risk (RR) of adverse events associated with use of bevacizumab, we systematically reviewed published clinical trials that studied use of bevacizumab in treatment of patients affected by metastatic CRC (mCRC).

Methods

The National Library of Medicine PubMed, MEDLINE, Ovid, Cochrane Library and Chinese Biomedicine databases were searched. The RR and number needed to harm (NNH) values for major side effects with 95 % confidence intervals (CIs) were calculated in a fixed-effects model and a random-effects model, where appropriate.

Results

Fifteen controlled trials totalling 6,937 patients were eligible for this analysis. Compared with the control group, the bevacizumab treatment group had a slightly higher risk of any severe adverse event (pooled RR 1.07 [95 % CI 1.02–1.12]). The pooled risk difference was 5 % [95 % CI 2–9 %], with an NNH of 20 treated patients. Analyses showed a statistically significantly higher risk of secondary endpoints, including the discovery that bevacizumab was associated with a threefold higher risk of hypertension (pooled RR 3.06 [95 % CI 2.45–3.83]), a twofold higher risk of gastrointestinal haemorrhage/perforation and a lower risk of neutropenia (pooled RR 0.75 [95 % CI 0.26–2.19]).

Conclusion

Bevacizumab has efficacy in all treatment regimens for advanced CRC. However, our meta-analysis raises safety concerns regarding an increased risk of serious adverse events associated with use of bevacizumab among patients with mCRC. Our findings warrant cautious use of bevacizumab in clinical oncology.
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Metadata
Title
Safety of Bevacizumab in Treating Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis of All Randomized Clinical Trials
Authors
Fei Dai
Lixing Shu
Yangfang Bian
Zhuo Wang
Zhangwei Yang
Wengong Chu
Shen Gao
Publication date
01-11-2013
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 11/2013
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-013-0125-6

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