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Safety profile of trastuzumab originator vs biosimilars: a systematic review and meta-analysis of randomized clinical trials

dc.rights.licenseopenen_US
dc.contributor.authorOLIVA, Andrea
dc.contributor.authorSCAVONE, Cristina
dc.contributor.authorRICCARDI, Consiglia
dc.contributor.authorBERNARDI, Francesca Futura
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
IDREF: 221043470
dc.contributor.authorMASCOLO, Annamaria
dc.date.accessioned2024-10-17T07:59:58Z
dc.date.available2024-10-17T07:59:58Z
dc.date.issued2024-09-18
dc.identifier.issn1699-3055en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/202549
dc.description.abstractEnPURPOSE: In the last decade trastuzumab biosimilars became more and more frequent. Among their uses, from several years, they have been available in Europe for the treatment of HER2-positive metastatic breast cancer, as an alternative to Herceptin®. METHODS/PATIENTS: This meta-analysis aimed to analyze the available literature with particular focus on phase 3 randomized clinical trials (RCTs) comparing adverse events between trastuzumab biosimilar and originator. A systematic review was conducted in Pubmed and Scopus to include all phase 3 RCTs related to trastuzumab in patients with HER2-positive breast cancer and published up to July 31, 2023. Of the 508 records identified, 14 articles were meta-analyzed for safety information, including serious treatment emergent adverse events, death-related adverse events, neutropenia, leukopenia, infections, increased ALT, increased AST, anti-drug antibody, and neutralizing antibody. RESULTS: Included patients had an early breast cancer (N=2,877) or a metastatic breast cancer (N=2,603). No significant difference in death-related adverse events was found for trastuzumab biosimilar and originator when evaluated for an early breast cancer in the neoadjuvant phase (Risk Ratio [RR], 1.30; 95% confidence interval [CI], 0.47-3.59; I2 = 0%; p = 0.57) and overall (RR, 0.43; 95%CI, 0.11-1.66; I2 = 20%; p = 0.26), and for metastatic breast cancer (RR, 0.61; 95%CI, 0.30-1.26; I2 = 0%; p = 0.85). CONCLUSIONS: No difference was also observed for all other safety outcomes as in accordance with clinical studies necessary for the registration and approval of a biosimilar at a European level.
dc.language.isoENen_US
dc.subject.enADR
dc.subject.enBiosimilar
dc.subject.enICSE
dc.subject.enPharmacovigilance
dc.subject.enTrastuzumab
dc.title.enSafety profile of trastuzumab originator vs biosimilars: a systematic review and meta-analysis of randomized clinical trials
dc.title.alternativeClin Transl Oncolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s12094-024-03642-xen_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed39292389en_US
bordeaux.journalClinical and Translational Oncologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04740863
hal.version1
hal.date.transferred2024-10-17T08:00:00Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20and%20Translational%20Oncology&rft.date=2024-09-18&rft.eissn=1699-3055&rft.issn=1699-3055&rft.au=OLIVA,%20Andrea&SCAVONE,%20Cristina&RICCARDI,%20Consiglia&BERNARDI,%20Francesca%20Futura&SALVO,%20Francesco&rft.genre=article


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