1. 'Weekly docetaxel and gemcitabine as first line treatment for metastatic breast cancer: results of a multicenter phase II study'
- Author
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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, 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, and DANOVA, M
- Subjects
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 - Abstract
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.
- Published
- 2005