Absence of pharmacokinetic drug–drug interaction of pertuzumab with trastuzumab and docetaxel

التفاصيل البيبلوغرافية
العنوان: Absence of pharmacokinetic drug–drug interaction of pertuzumab with trastuzumab and docetaxel
المؤلفون: Maik Hauschild, Bert L. Lum, Taral Patel, Graham Ross, Amit Garg, Jean-Francois Marier, Mike Brewster, Sandra M. Swain, Javier Cortes, Elza Grincuka, Jennifer Visich, V. McNally, My My Trinh, Norikazu Masuda, José Baselga, Ihsan Nijem, Iveta Kudaba
المصدر: Anti-Cancer Drugs. 24:1084-1092
بيانات النشر: Ovid Technologies (Wolters Kluwer Health), 2013.
سنة النشر: 2013
مصطلحات موضوعية: Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Population, Cmax, Breast Neoplasms, Docetaxel, Antibodies, Monoclonal, Humanized, Models, Biological, Drug Administration Schedule, Cmin, Pharmacokinetics, Trastuzumab, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Drug Interactions, Pharmacology (medical), Neoplasm Metastasis, skin and connective tissue diseases, education, neoplasms, Pharmacology, education.field_of_study, business.industry, Middle Aged, medicine.disease, Metastatic breast cancer, Female, Taxoids, Pertuzumab, business, medicine.drug
الوصف: 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 µg/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.
تدمد: 0959-4973
DOI: 10.1097/cad.0000000000000016
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bbfb0f2b9a485347ac8e6112ab703063
https://doi.org/10.1097/cad.0000000000000016
رقم الانضمام: edsair.doi.dedup.....bbfb0f2b9a485347ac8e6112ab703063
قاعدة البيانات: OpenAIRE
الوصف
تدمد:09594973
DOI:10.1097/cad.0000000000000016