A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer

DENG Weishang; LI Mengting; HU Jia; YANG Sensen; CHEN Jisheng

doi:10.6039/j.issn.1001-0408.2022.20.19

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A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer

更新时间：2025-12-05

- A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer
- ZHONGGUO YAOFANG Vol. 33, Issue 20, Pages: 2529-2533(2022)
- 作者机构：
  
  广东药科大学附属第一医院临床药学重点专科，广州　510080
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2022.20.19
  CLC： R979.1
- Received：26 January 2022，
  
  Revised：2022-09-22，
  
  Published：30 October 2022
- 稿件说明：
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邓为上,李梦婷,胡佳,等.曲妥珠单抗生物类似药对比原研药治疗HER-2阳性乳腺癌有效性和安全性的Meta分析[J].中国药房,2022,33(20):2529-2533.

DENG Weishang,LI Mengting,HU Jia,et al.A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer[J].ZHONGGUO YAOFANG,2022,33(20):2529-2533.
邓为上,李梦婷,胡佳,等.曲妥珠单抗生物类似药对比原研药治疗HER-2阳性乳腺癌有效性和安全性的Meta分析[J].中国药房,2022,33(20):2529-2533. DOI： 10.6039/j.issn.1001-0408.2022.20.19.

DENG Weishang,LI Mengting,HU Jia,et al.A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer[J].ZHONGGUO YAOFANG,2022,33(20):2529-2533. DOI： 10.6039/j.issn.1001-0408.2022.20.19.

摘要

目的

系统评价曲妥珠单抗生物类似药与原研药治疗人表皮生长因子受体2（HER-2）阳性乳腺癌的有效性和安全性，为临床治疗提供循证证据。

方法

计算机检索PubMed、Embase、Web of Science、Cochrane Library、中国期刊全文数据库、中国生物医学文献数据库、维普网、万方数据、ClinicalTrials和中国临床试验中心等数据库，收集曲妥珠单抗生物类似药（试验组）对比原研药（对照组）治疗HER-2阳性乳腺癌的随机对照试验（RCT）。经资料提取、质量评价后，采用RevMan 5.4软件进行Meta分析。

结果

共纳入11项RCT，合计5 812例患者。Meta分析结果显示，两组患者的客观缓解率（无论是按意向性治疗分配人群还是按完成方案分配人群）、病理完全缓解率、无进展生存人群比例、总生存人群比例、抗药抗体阳性率、中和抗体阳性率、不良反应发生率比较，差异均无统计学意义（

＞0.05）。

结论

曲妥珠单抗生物类似药与原研药的有效性和安全性相当。

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of trastuzumab biosimilars and original drugs in the treatment of human epidermal growth factor receptor-2 （HER-2） positive breast cancer systematically， and to provide evidence-based basis for the selection of clinical treatment.

METHODS

Retrieved from PubMed， Embase， Web of Science， Cochrane Library， CNKI，CBM， VIP， Wanfang database，ClinicalTrials and Clinical Trial Center of China， randomized controlled trials （RCTs） about trastuzumab biosimilars （trial group） versus original drugs （control group） in the treatment of HER-2 positive breast cancer were collected. After data extraction and quality evaluation， RevMan 5.4 statistical software was used for meta-analysis.

RESULTS

Totally 11 RCTs were enrolled， involving 5 812 patients. Results of meta-analysis showed that there was no significant difference in objective response rate （based on whether intention-to-treat population nor per-protocol population）， pathologic complete response， proportion of progression free survival population， proportion of overall survival population， anti-drug antibody positive rate， neutralizing antibody positive rate， and incidence of adverse drug reactions between 2 groups （

＞0.05）.

CONCLUSIONS

The effectiveness and safety of trastuzumab biosimilars are equivalent to those of trastuzumab original drugs.

关键词

Keywords

references

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