'Weekly docetaxel and gemcitabine as first line treatment for metastatic breast cancer: results of a multicenter phase II study'
Autor: | Laura Palmeri, Marco Danova, Giuseppe Comella, S. Spada, G. De Cataldis, Sergio Palmeri, Gianfranco Filippelli, G. Condemi, Antonio Farris, M. Vaglica, A. Mangiameli, Massimo Cajozzo, Maria Catena Macaluso, Vincenza Leonardi, Bruno Massidda, A. Misino, E. Iannitto, F. Ferraù |
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Přispěvatelé: | PALMERI, S, VAGLICA, M, SPADA, S, FILIPPELLI, G, FARRIS, A, PALMERI, L, MASSIDDA, B, MISINO, A, FERRAU', F, COMELLA, G, LEONARDI, V, CONDEMI, G, MANGIAMELI, A, DE CATALDIS, G, MACALUSO, MC, CAJOZZO, M, IANNITTO, E, DANOVA, M |
Jazyk: | angličtina |
Rok vydání: | 2005 |
Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty Maximum Tolerated Dose medicine.drug_class Phases of clinical research Breast Neoplasms Docetaxel Antimetabolite Deoxycytidine Metastasis Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans Aged Neoplasm Staging business.industry Carcinoma Ductal Breast General Medicine Middle Aged medicine.disease Metastatic breast cancer Gemcitabine Surgery Survival Rate Carcinoma Lobular Treatment Outcome Carcinoma Medullary Toxicity Female Taxoids business medicine.drug |
Popis: | Objectives: We conducted a multicenter phase II study to evaluate the clinical efficacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabine as first-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel 35 mg/m2 and gemcitabine 800 mg/m2 i.v. on days 1, 8, 15 every 28 days. Results: All patients were assessable for toxicity and 56 for efficacy. Overall response rate was 64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrile neutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experienced grade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule, in agreement with other published studies, need to be further confirmed within a phase III study. |
Databáze: | OpenAIRE |
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