Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor: A high-activity, dose-dense weekly regimen for advanced breast cancer

Background: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). Patients and methods: Fifty- two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m²/week) and vinorelbine (25 mg/m²/week) with G-CSF support, for 24 consecutive weeks. Results: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m² for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). Conclusions: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.