Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study.

PURPOSE: In this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated. METHODS: Epirubicin (75 mg/m(2)) and docetaxel (75 mg/m(2)) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC. RESULTS: The overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7-12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure. CONCLUSIONS: The combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.

A dose-dense schedule of docetaxel followed by doxorubicin and cyclophosphamide as neoadjuvant treatment for breast cancer: results from a phase II study.

INTRODUCTION: The objective was to evaluate a dose-dense schedule of docetaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant treatment for patients with locally advanced breast cancer. PATIENTS AND METHODS: Ninety-nine patients were included and received 100 mg/m(2) of docetaxel every two weeks for four cycles followed by 60 mg/m(2) of doxorubicin and 600 mg/m(2) of cyclophosphamide every two weeks for four cycles. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) was administered systematically to all patients. RESULTS: Efficacy and toxicity analyses were carried out on an intention-to-treat basis. After treatment, complete pathological response in the breast and lymph nodes was confirmed in 15 patients (15%, 95% confidence interval [CI]: 8.4-22.9). Clinical response rate was 74% (95% CI: 65-82), of which 19% were complete responses. Breast-conserving surgery could be performed in 41% of patients. The dose-dense schedule was generally well tolerated. The most important grade 3/4 toxicities per patient were cutaneous toxicity (12.1%) and hepatic dysfunction (9.1%) during docetaxel administration, and neutropenia (28.1%) and leucopenia (8.3%) with AC. CONCLUSION: A dose-dense schedule of docetaxel followed by AC as neoadjuvant treatment is an effective and safe treatment for locally advanced breast cancer. Primary prophylaxis with G-CSF, and possibly the change in the sequence of drug administration, appears to play a major role in avoiding the excessive toxicity of dose-dense schedules.