Nina K. Song BPharm (Hons), Hala Musa BSc (Hons), MSc, MPharm, Michael Soriano BS Pharmacy (PH), Mellissa Batger BSc, MPharm, Bryson Hawkins BPharm (Hons), Iqbal Ramzan Dip Pharmacy (NZ), MSc, PhD, David E. Hibbs BSc (Hons), PhD, Grad Cert Ed (Higher Ed), Jennifer Ong BPharm (Hons), PhD, Grad Cert Ed Studies (Higher Ed)
{"title":"静脉注射曲妥珠单抗生物仿制药与参比产品药物在乳腺癌新患者和转归患者中的安全性和疗效比较：系统和荟萃分析","authors":"Nina K. Song BPharm (Hons), Hala Musa BSc (Hons), MSc, MPharm, Michael Soriano BS Pharmacy (PH), Mellissa Batger BSc, MPharm, Bryson Hawkins BPharm (Hons), Iqbal Ramzan Dip Pharmacy (NZ), MSc, PhD, David E. Hibbs BSc (Hons), PhD, Grad Cert Ed (Higher Ed), Jennifer Ong BPharm (Hons), PhD, Grad Cert Ed Studies (Higher Ed)","doi":"10.1002/jppr.1882","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aim</h3>\n \n <p>To compare the efficacy and safety of trastuzumab biosimilars to reference trastuzumab in patients with breast cancer. Trastuzumab, a biologic pharmaceutical product, has improved survival in hormone-oestrogen receptor 2 positive breast cancer. However, due to its high economic burden, ‘highly similar’ products known as biosimilars have been developed. Yet, concerns remain around the equivalency of efficacy and safety between biosimilars and their reference biologic.</p>\n </section>\n \n <section>\n \n <h3> Data Sources</h3>\n \n <p>A systematic review with meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 26 April 2021 to obtain all randomised control trial data reporting on safety and efficacy outcomes of patients with breast cancer treated with trastuzumab biosimilars.</p>\n </section>\n \n <section>\n \n <h3> Study Selection</h3>\n \n <p>Studies were required to investigate and report on the safety and/or efficacy of trastuzumab. No restrictions were placed on study setting or intervention type and any study which reported at least one efficacy or safety outcome was included. A head-to-head comparison between the biosimilar and its reference biologic was not required for inclusion in the results. Only studies using randomised control trials were included. There was no restriction on the language the study was published in, and all abstracts, raw clinical trial data, and full-text studies were eligible.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Forty-one studies were identified to report on patients treated with trastuzumab. The odds of achieving an overall response rate in patients treated with a trastuzumab biosimilar compared to the reference over at least 24 weeks of treatment was 1.10 (95% confidence interval [CI] 0.94–1.29). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms, 1.07 (95% CI 0.87–1.32). The switching group contained one study with 342 patients in the meta-analysis.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Trastuzumab biosimilars have comparable efficacy and safety to reference trastuzumab in treatment-naïve patients. However, evidence is lacking for switching patients from reference trastuzumab to biosimilars, so further work is required in the switch-over population.</p>\n </section>\n </div>","PeriodicalId":16795,"journal":{"name":"Journal of Pharmacy Practice and Research","volume":"54 1","pages":"1-32"},"PeriodicalIF":1.0000,"publicationDate":"2023-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jppr.1882","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy comparisons of intravenous trastuzumab biosimilars to the reference product medicine in treatment-naïve and switch-over patients with breast cancer: a systematic and meta-analysis\",\"authors\":\"Nina K. Song BPharm (Hons), Hala Musa BSc (Hons), MSc, MPharm, Michael Soriano BS Pharmacy (PH), Mellissa Batger BSc, MPharm, Bryson Hawkins BPharm (Hons), Iqbal Ramzan Dip Pharmacy (NZ), MSc, PhD, David E. 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Safety and efficacy comparisons of intravenous trastuzumab biosimilars to the reference product medicine in treatment-naïve and switch-over patients with breast cancer: a systematic and meta-analysis
Aim
To compare the efficacy and safety of trastuzumab biosimilars to reference trastuzumab in patients with breast cancer. Trastuzumab, a biologic pharmaceutical product, has improved survival in hormone-oestrogen receptor 2 positive breast cancer. However, due to its high economic burden, ‘highly similar’ products known as biosimilars have been developed. Yet, concerns remain around the equivalency of efficacy and safety between biosimilars and their reference biologic.
Data Sources
A systematic review with meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 26 April 2021 to obtain all randomised control trial data reporting on safety and efficacy outcomes of patients with breast cancer treated with trastuzumab biosimilars.
Study Selection
Studies were required to investigate and report on the safety and/or efficacy of trastuzumab. No restrictions were placed on study setting or intervention type and any study which reported at least one efficacy or safety outcome was included. A head-to-head comparison between the biosimilar and its reference biologic was not required for inclusion in the results. Only studies using randomised control trials were included. There was no restriction on the language the study was published in, and all abstracts, raw clinical trial data, and full-text studies were eligible.
Results
Forty-one studies were identified to report on patients treated with trastuzumab. The odds of achieving an overall response rate in patients treated with a trastuzumab biosimilar compared to the reference over at least 24 weeks of treatment was 1.10 (95% confidence interval [CI] 0.94–1.29). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms, 1.07 (95% CI 0.87–1.32). The switching group contained one study with 342 patients in the meta-analysis.
Conclusion
Trastuzumab biosimilars have comparable efficacy and safety to reference trastuzumab in treatment-naïve patients. However, evidence is lacking for switching patients from reference trastuzumab to biosimilars, so further work is required in the switch-over population.
期刊介绍：
The purpose of this document is to describe the structure, function and operations of the Journal of Pharmacy Practice and Research, the official journal of the Society of Hospital Pharmacists of Australia (SHPA). It is owned, published by and copyrighted to SHPA. However, the Journal is to some extent unique within SHPA in that it ‘…has complete editorial freedom in terms of content and is not under the direction of the Society or its Council in such matters…’. This statement, originally based on a Role Statement for the Editor-in-Chief 1993, is also based on the definition of ‘editorial independence’ from the World Association of Medical Editors and adopted by the International Committee of Medical Journal Editors.
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