Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2020 Nov;86(5):577-588.
doi: 10.1007/s00280-020-04156-3. Epub 2020 Oct 1.

Comparative efficacy and safety of trastuzumab biosimilars to the reference drug: a systematic review and meta-analysis of randomized clinical trials

Sarah Cargnin  1 , Jae Il Shin  2 , Armando A Genazzani  1 , Alessia Nottegar  3 , Salvatore Terrazzino  4
Affiliations
Meta-Analysis

Comparative efficacy and safety of trastuzumab biosimilars to the reference drug: a systematic review and meta-analysis of randomized clinical trials

Sarah Cargnin et al. Cancer Chemother Pharmacol. 2020 Nov.

Abstract

Purpose: To assess efficacy and safety of trastuzumab biosimilars in comparison to the reference drug through a systematic review and meta-analysis of randomized controlled trials (RCTs).

Methods: A comprehensive search was conducted using PubMed, Web of Science, Cochrane library, Open Grey and ClinicalTrials.gov databases. Dichotomous data for efficacy and safety outcomes were pooled to obtain the relative risk (RR) and 95% confidence intervals (CIs). Meta-analysis was performed with the Mantel-Haenszel method using Revman 5.3 software.

Results: Eight phase III RCTs including a total of 3913 patients with HER2 + breast cancer were identified that met the inclusion criteria. The pooled results for the comparison of trastuzumab biosimilars to the reference drug showed no differences of objective response rate (ORR) (RR 1.05, 95% CI 0.98-1.12, P = 0.20) or overall survival (RR 0.82, 95% CI 0.61-1.09, P = 0.17) in the intention-to-treat population, as well as no difference of ORR (RR 1.03, 95% CI 0.97-1.10, P = 0.30) in the per-protocol population. Similarly, no significant difference was detected in any type of adverse event reported in at least three RCTs, including any serious treatment-emergent adverse effects (RR 0.97, 95% CI 0.76-1.25, P = 0.83), heart failure (RR 1.47, 95% CI 0.69-3.14, P = 0.32), neutropenia (RR 1.05, 95% CI 0.96-1.15, P = 0.26), and infusion-related reaction (RR 1.10, 95% CI 0.89-1.36, P = 0.38).

Conclusion: This meta-analysis provides compelling evidence of clinical comparability between trastuzumab biosimilars and the originator product in terms of both efficacy and safety for the treatment of HER2 + breast cancer.

Keywords: Biosimilars; Efficacy; Meta-analysis; Randomized clinical trials; Safety; Trastuzumab.

PubMed Disclaimer

References

    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 68:394–424. https://doi.org/10.3322/caac.21492 - DOI
    1. Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Nikšić M, Bonaventure A, Valkov M, Johnson CJ, Estève J, Ogunbiyi OJ, Azevedo E, Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP, CONCORD Working Group (2018) Global surveillance of trends in cancer survival 2000–14 (CONCORD-3): analysis of individual records for 37,513,025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet 17(391):1023–1075. https://doi.org/10.1016/S0140-6736(17)33326-3 - DOI
    1. Zeng H, Chen W, Zheng R, Zhang S, Ji JS, Zou X, Xia C, Sun K, Yang Z, Li H, Wang N, Han R, Liu S, Li H, Mu H, He Y, Xu Y, Fu Z, Zhou Y, Jiang J, Yang Y, Chen J, Wei K, Fan D, Wang J, Fu F, Zhao D, Song G, Chen J, Jiang C, Zhou X, Gu X, Jin F, Li Q, Li Y, Wu T, Yan C, Dong J, Hua Z, Baade P, Bray F, Jemal A, Yu XQ, He J (2018) Changing cancer survival in China during 2003–15: a pooled analysis of 17 population-based cancer registries. Lancet Glob Health 6:e555–e567. https://doi.org/10.1016/S2214-109X(18)30127-X - DOI
    1. Malvezzi M, Carioli G, Bertuccio P, Boffetta P, Levi F, La Vecchia C, Negri E (2019) European cancer mortality predictions for the year 2019 with focus on breast cancer. Ann Oncol 30:781–787. https://doi.org/10.1093/annonc/mdz051 - DOI
    1. Fabi A, Malaguti P, Vari S, Cognetti F (2016) First-line therapy in HER2 positive metastatic breast cancer: is the mosaic fully completed or are we missing additional pieces? J Exp Clin Cancer Res 35:104. https://doi.org/10.1186/s13046-016-0380-5 - DOI

MeSH terms

LinkOut - more resources