Show simple item record Lammers, PE Dank, Magdolna Masetti, R Abbas, R Hilton, F Coppola, J Jacobs, I 2020-03-25T11:03:37Z 2020-03-25T11:03:37Z 2018
dc.identifier.citation journalVolume=119;journalIssueNumber=3;journalTitle=BRITISH JOURNAL OF CANCER;pagerange=266-273;journalAbbreviatedTitle=BRIT J CANCER;
dc.identifier.uri doi:10.1038/s41416-018-0147-1
dc.description.abstract BACKGROUND: This randomised, double-blind study compared pharmacokinetics, efficacy, safety and immunogenicity of PF-05280014 (potential trastuzumab biosimilar) and trastuzumab reference product (Herceptin) sourced from the European Union (trastuzumab-EU) as neoadjuvant treatment for operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer. METHODS: Patients (N = 226), stratified by primary tumour size and hormone receptor status, were randomised 1:1 to PF-05280014 or trastuzumab-EU (8 mg/kg loading dose; 6 mg/kg thereafter), each with docetaxel and carboplatin, every 3 weeks for six treatment cycles. Primary endpoint was percentage of patients with trough plasma concentration (Ctrough) >20 mug/ml at Cycle 5 (Cycle 6 predose). Efficacy endpoints included pathological complete response and objective response rate. Non-inferiority of PF-05280014 to trastuzumab-EU was declared if the lower limit of the 95% confidence interval for the stratified difference between groups in the percentage of patients with Cycle 5 Ctrough >20 mug/ml was above the prespecified non-inferiority margin of - 12.5%. RESULTS: For PF-05280014 vs trastuzumab-EU patients, respectively, 92.1% vs 93.3% had Cycle 5 Ctrough >20 mug/ml; the lower limit of the 95% confidence interval (- 8.02%, 6.49%) for the stratified difference between groups was above the non-inferiority margin (- 12.5%). Pathological complete response (47.0% vs 50.0%) and central radiology review-assessed objective response (88.1% vs 82.0%) rates were comparable. Incidence of all-causality, grade 3-4 treatment-emergent adverse events was 38.1% vs 45.5%; antidrug antibody rates were 0% vs 0.89%. CONCLUSIONS: PF-05280014 demonstrated non-inferior pharmacokinetics and comparable efficacy, safety and immunogenicity to trastuzumab-EU in patients with operable HER2-positive breast cancer receiving neoadjuvant chemotherapy.
dc.format.extent 266-273
dc.relation.ispartof urn:issn:0007-0920
dc.title Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer
dc.type Journal Article 2019-08-13T14:55:11Z
dc.language.rfc3066 en
dc.rights.holder NULL
dc.identifier.mtmt 3398462
dc.identifier.wos 000440320600002
dc.identifier.pubmed 30002437
dc.contributor.department SE/AOK/K/Onkológiai Központ
dc.contributor.institution Semmelweis Egyetem

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