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Journal of ZheJiang University(Medical Science)  2016, Vol. 45 Issue (4): 379-386    DOI: 10.3785/j.issn.1008-9292.2016.07.08
    
Efficacy of neoadjuvant chemotherapy combined with bevacizumab versus neoadjuvant chemotherapy alone for Her2-negative breast cancer: a meta-analysis of randomized controlled clinical trials
HAN Rui, WANG Guanying, ZHANG Yujiao, ZHAO Xinhan
Department of Oncology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China
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Abstract  

Objective: To evaluate the efficacy and safety of neoadjuvant chemotherapy combined with bevacizumab versus neoadjuvant chemotherapy alone for Her2-negative breast cancer.Methods: We searched PubMed, the Cochrane Library, Web of Science, CNKI, Wanfang Database and the abstracts of major international conferences in recent 5 years to identify prospective randomized controlled clinical trials that met the inclusion and exclusion criteria. Study selection and analyses were undertaken according to the Cochrane Handbook. Meta-analysis was performed using RevMan 5.3 software.Results: Six trials were identified with 4440 eligible patients. The results of this meta-analysis showed that the rate of pathological complete response (pCR) was higher in Her-2 negative breast cancer patients receiving bevacizumab combined with neoadjuvant chemotherapy than that in patients with neoadjuvant chemotherapy alone (24.7% vs 20.1%, RR=1.23, 95%CI:1.10-1.37, P<0.01). In addition, the pCR rate rose up when bevacizumab was added to neoadjuvant chemotherapy both in hormone receptor-positive patients (13.1% vs 10.2%,RR=1.28, 95%CI:1.04-1.58,P<0.05) and in hormone receptor-negative patients (46.3% vs 37.1%, RR=1.25, 95%CI:1.12-1.39, P<0.01). Statistical differences were observed in the rate of relevant adverse events such as hypertention (3.2% vs 0.6%, RR=5.292, 95%CI:2.933-9.549, P<0.01) and mucositis (10.5% vs 2.0%, RR=5.340, 95%CI:3.743-7.617, P<0.01) between the combination group and the chemotherapy alone group. Differences in other toxicities such as febrile neutropenia, infection, surgical complications, neutropenia and hand-foot syndrome were also found to be statistically significant between the combination group and the chemotherapy alone group (all P<0.05), while such difference was not found in the occurrence of peripheral neuropathy (P>0.05). Conclusion: The addition of bevacizumab to neoadjuvant chemotherapy in Her2-negative breast cancer can significantly improve pathological complete response, but may bring more grade 3 and 4 toxicities.More neoadjuvant trials need to be done to define subgroups of Her2-negative breast cancer that would have clinically significant long-term benefit from bevacizumab treatment.



Key wordsMeta-analysis      Breast neoplasms/drug therapy      Antibodies, monoclonal/therapeutic use      Receptor, epidermal growth factor/analysis      Chemotherapy, adjuvant     
Received: 03 June 2016     
CLC:  R686  
Cite this article:

HAN Rui, WANG Guanying, ZHANG Yujiao, ZHAO Xinhan. Efficacy of neoadjuvant chemotherapy combined with bevacizumab versus neoadjuvant chemotherapy alone for Her2-negative breast cancer: a meta-analysis of randomized controlled clinical trials. Journal of ZheJiang University(Medical Science), 2016, 45(4): 379-386.

URL:

http://www.zjujournals.com/xueshu/med/10.3785/j.issn.1008-9292.2016.07.08     OR     http://www.zjujournals.com/xueshu/med/Y2016/V45/I4/379


贝伐珠单克隆抗体联合化疗用于Her2阴性乳腺癌患者新辅助治疗的meta分析

目的:评价贝伐珠单克隆抗体(贝伐珠单抗)联合化疗在Her2阴性乳腺癌患者新辅助治疗中的有效性和安全性。方法:检索PubMed、the Cochrane Library、Web of Science、中国期刊全文数据库、万方医药期刊全文数据库和近5年重要国际肿瘤学会议摘要,严格按照纳入与排除标准收集Her2阴性乳腺癌患者使用新辅助化疗联合贝伐珠单抗(联合组)对比单用新辅助化疗(化疗组)的有效性和安全性的前瞻性随机对照研究。按Cochrane系统评价方法进行质量评价,资料提取后运用RevMan 5.3软件进行meta分析。结果:最终纳入六项随机对照临床试验,共4440例患者符合条件。Meta分析结果显示,联合组较化疗组病理完全缓解率有所提高(24.7%与20.1%,RR=1.23,95%CI:1.10~1.37,P<0.01);联合组无论激素受体是否阳性均可提高病理完全缓解率(激素受体阳性亚组:13.1%与10.2%,RR=1.28,95%CI:1.04~1.58,P<0.05;激素受体阴性亚组:46.3%与37.1%,RR=1.25,95%CI:1.12~1.39,P<0.01);联合组高血压(3.2%与0.6%,RR=5.292,95%CI:2.933~9.549,P<0.01)、黏膜炎(10.5%与2.0%,RR=5.340,95%CI:3.743~7.617,P<0.01)的发生率更高,其他不良反应如中性粒细胞减少性发热、感染、手术并发症、中性粒细胞减少、手足综合征联合组的发生率均高于化疗组(均P<0.05),而周围神经病变发生率两组间差异并无统计学意义(P>0.05)。结论:在Her2阴性乳腺癌患者的新辅助治疗中,不论患者激素受体阳性与否,采用新辅助化疗联合贝伐珠单抗靶向治疗效果较好,但一些不良反应发生率也相应增加,需要更多的临床研究来筛选出优势人群。


关键词: Meta分析,  乳腺肿瘤/药物疗法,  抗体,单克隆/治疗应用,  受体,表皮生长因子/分析,  化学疗法,辅助 
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