Absence of pharmacokinetic drug-drug interaction of pertuzumab with trastuzumab and docetaxel.

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Citation: Anti-Cancer Drugs. 24(10):1084-92, 2013 Nov.PMID: 23969513Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Research Support, Non-U.S. Gov'tSubject headings: *Antibodies, Monoclonal, Humanized/pk [Pharmacokinetics] | *Antineoplastic Combined Chemotherapy Protocols/pk [Pharmacokinetics] | *Breast Neoplasms/dt [Drug Therapy] | *Taxoids/pk [Pharmacokinetics] | Antibodies, Monoclonal, Humanized/ad [Administration & Dosage] | Antibodies, Monoclonal, Humanized/bl [Blood] | Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | Antineoplastic Combined Chemotherapy Protocols/ad [Administration & Dosage] | Antineoplastic Combined Chemotherapy Protocols/bl [Blood] | Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | Breast Neoplasms/bl [Blood] | Breast Neoplasms/me [Metabolism] | Breast Neoplasms/pa [Pathology] | Drug Administration Schedule | Drug Interactions | Female | Humans | Middle Aged | Models, Biological | Neoplasm Metastasis | Receptor, erbB-2/me [Metabolism] | Taxoids/ad [Administration & Dosage] | Taxoids/tu [Therapeutic Use]Year: 2013Local holdings: Available online from MWHC library: 2000 - presentISSN:
  • 0959-4973
Name of journal: Anti-cancer drugsAbstract: Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined with trastuzumab plus docetaxel, pertuzumab improved progression-free and overall survival versus trastuzumab plus docetaxel in the phase III CLEOPATRA trial (NCT00567190) in first-line HER2-positive metastatic breast cancer. Thirty-seven patients participated in a pharmacokinetic (PK)/corrected QT interval substudy of CLEOPATRA, which evaluated potential PK drug-drug interaction (DDI). PK parameters were calculated using noncompartmental methods, and DDI analyses were carried out. In the presence of trastuzumab and docetaxel, the mean pertuzumab Cmin and Cmax in cycle 3 were 63.6 and 183 g/ml, respectively. The pertuzumab concentrations observed were consistent with simulations from a validated population PK model, indicating that trastuzumab and docetaxel did not alter pertuzumab PK. Comparison of geometric least-squares mean PK parameters between arms showed no impact of pertuzumab on the PK of trastuzumab or docetaxel. In conclusion, no PK DDI was observed when pertuzumab, trastuzumab, and docetaxel were combined for the treatment of HER2-positive metastatic breast cancer.All authors: Baselga J, Brewster M, Cortes J, Garg A, Grincuka E, Hauschild M, Kudaba I, Lum BL, Marier JF, Masuda N, McNally V, Nijem I, Patel T, Ross G, Swain SM, Trinh MM, Visich JFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-04-04
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Journal Article MedStar Authors Catalog Article 23969513 Available 23969513

Available online from MWHC library: 2000 - present

Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined with trastuzumab plus docetaxel, pertuzumab improved progression-free and overall survival versus trastuzumab plus docetaxel in the phase III CLEOPATRA trial (NCT00567190) in first-line HER2-positive metastatic breast cancer. Thirty-seven patients participated in a pharmacokinetic (PK)/corrected QT interval substudy of CLEOPATRA, which evaluated potential PK drug-drug interaction (DDI). PK parameters were calculated using noncompartmental methods, and DDI analyses were carried out. In the presence of trastuzumab and docetaxel, the mean pertuzumab Cmin and Cmax in cycle 3 were 63.6 and 183 g/ml, respectively. The pertuzumab concentrations observed were consistent with simulations from a validated population PK model, indicating that trastuzumab and docetaxel did not alter pertuzumab PK. Comparison of geometric least-squares mean PK parameters between arms showed no impact of pertuzumab on the PK of trastuzumab or docetaxel. In conclusion, no PK DDI was observed when pertuzumab, trastuzumab, and docetaxel were combined for the treatment of HER2-positive metastatic breast cancer.

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