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贝伐单抗不能降低化疗相关贫血的风险:一项最新的荟萃分析。

Bevacizumab did not reduce the risk of anemia associated with chemotherapy: an up-to-date meta-analysis.

作者信息

Wang Zuo-Pei, Zhang Hai-Feng, Zhang Feng, Hu Bao-Li, Wei Hai-Tao, Guo Yong-Yuan

机构信息

Cardiothoracic Surgery, Huaihe Hospital, Henan University, No. 8 Baobei Road, Kaifeng, 475000, Henan, China.

出版信息

Eur J Clin Pharmacol. 2015 May;71(5):517-24. doi: 10.1007/s00228-015-1818-y. Epub 2015 Apr 7.

DOI:10.1007/s00228-015-1818-y
PMID:25845654
Abstract

PURPOSE

The risk of anemia due to bevacizumab-based chemotherapy has not been well described, and new randomized controlled trials (RCTs) have been reported in recent years. We therefore conducted an up-to-date meta-analysis of RCTs to fully characterize the risk of anemia with bevacizumab.

METHODS

We carried out an electronic search of Medline, Embase, and The Cochrane Central Register of Controlled Trials to investigate the effects of RCTs on bevacizumab treatment on cancer patients up to October 2014, and random or fixed-effect meta-analytical models were used to assess the risk ratio (RR) of anemia due to the use of bevacizumab according to the heterogeneity of included studies.

RESULTS

A total of 13,173 patients were included in this analysis from 18 RCTs. Among those patients receiving bevacizumab and chemotherapy, the incidences of all-grade and high-grade (grade 3 and above) anemia were 24% (95% confidence interval (CI) 13-41%) and 4.0% (95% CI 3.0-6.0%), respectively. Bevacizumab-containing therapy did not significantly decreased the risk of developing all-grade anemia (RR 0.872, 95% CI 0.739-1.029, P = 0.104) and high-grade anemia (RR 0.850, 95% CI 0.720-1.002, P = 0.053), which is not in agreement with previous meta-analysis. On subgroup analysis, we did not find significant risk differences based on bevacizumab dosage, tumor types, and concomitant drugs. When stratified by dose level, a significantly decreased risk of high-grade anemia with bevacizumab was obtained in a lower dose level (2.5 mg/kg/week, RR 0.773, 95% CI 0.611-0.978, P = 0.031) compared to control group.

CONCLUSIONS

Bevacizumab did not significantly reduce the risk of anemia with chemotherapy in cancer patients.

摘要

目的

基于贝伐单抗的化疗导致贫血的风险尚未得到充分描述,近年来已有新的随机对照试验(RCT)报道。因此,我们对RCT进行了最新的荟萃分析,以全面描述贝伐单抗导致贫血的风险。

方法

我们对Medline、Embase和Cochrane对照试验中央注册库进行了电子检索,以调查截至2014年10月RCT对癌症患者贝伐单抗治疗的影响,并根据纳入研究的异质性,使用随机或固定效应荟萃分析模型评估使用贝伐单抗导致贫血的风险比(RR)。

结果

本分析共纳入了来自18项RCT的13173例患者。在接受贝伐单抗和化疗的患者中,所有级别和高级别(3级及以上)贫血的发生率分别为24%(95%置信区间(CI)13 - 41%)和4.0%(95%CI 3.0 - 6.0%)。含贝伐单抗的治疗并未显著降低发生所有级别贫血(RR 0.872,95%CI 0.739 - 1.029,P = 0.104)和高级别贫血(RR 0.850,95%CI 0.720 - 1.002,P = 0.053)的风险,这与之前的荟萃分析结果不一致。在亚组分析中,我们未发现基于贝伐单抗剂量、肿瘤类型和伴随药物的显著风险差异。按剂量水平分层时,与对照组相比,较低剂量水平(2.5 mg/kg/周)的贝伐单抗显著降低了高级别贫血的风险(RR 0.773,95%CI 0.611 - 0.978,P = 0.031)。

结论

贝伐单抗并未显著降低癌症患者化疗时贫血的风险。

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Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab.
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