Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group
| Autor: | Michael D. Green, Antonio Antón, Anna Lluch, Francesco Cognetti, John Kennedy, Dominique Maraninchi, David Grimes, Kenneth J. O'Byrne, Stephen Chan, Raymond Snyder, Carol Ward, Karen Mayne, Louis Mauriac, Jean-Marc Extra, Pierfranco Conte, M Marty, Michèle Tubiana-Hulin |
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| Jazyk: | angličtina |
| Rok vydání: | 2005 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Neutropenia Adolescent Receptor ErbB-2 medicine.medical_treatment Phases of clinical research Breast Neoplasms Docetaxel Antibodies Monoclonal Humanized Vinorelbine chemistry.chemical_compound Trastuzumab Internal medicine Multicenter trial Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis neoplasms Aged Chemotherapy metastatic breast cancer trastuzumab business.industry Antibodies Monoclonal Leukopenia Middle Aged Surgery chemistry Trastuzumab emtansine Drug Evaluation Female Taxoids Pertuzumab business medicine.drug |
| Popis: | Purpose This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2) –positive metastatic breast cancer (MBC). Patients and Methods Patients were randomly assigned to six cycles of docetaxel 100 mg/m2 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression. Results A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months. Conclusion Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity. |
| Databáze: | OpenAIRE |
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