Epirubicin plus docetaxel in metastatic breast cancer: Escalating dose does not improve efficacy. A phase II study

Background: The combination of anthracyclines and docetaxel have demonstrated a significant activity in metastatic breast cancer (MBC) as first-line chemotherapy. In a previous multicenter phase I study, we recommended two schedules of epirubicin-docetaxel combination for MBC: 1) epirubicin 75 mg/m², docetaxel 80 mg/m² every 3 weeks without G-CSF; 2) epirubicin 90 mg/m² plus docetaxel 90 mg/m² every 3 weeks, with G-CSF support. Patients and Methods: Twenty-five advanced breast cancer patients were treated with epirubicin 90 mg/m² plus docetaxel 90 mg/m² every 3 weeks, with prophylactic G-CSF. Results: The main toxicity was grade 3-4 neutropenia (41% of cycles) despite the use of G-CSF; febrile neutropenia was observed in 14% of cycles necessitating a dose reduction of both drugs in 30% of patients. Response was observed in 79% of patients: 21% complete responses and 58% partial responses. The median response duration was 10 months (range: 3-16). The median time to progression was 11 months. The overall 3-year survival was 49.7%. Conclusion: The antitumor activity observed in this series was comparable with that seen in other studies of taxane/anthracycline combinations. The degree of myelosuppression was severe, even though G-CSF was administered as a prophylactic. We recommend a lower dose of both drugs as reported by other authors.