Primary chemotherapy with epirubicin and vinorelbine in women with locally advanced breast cancer

Background: To assess the activity and toxicity of primary chemotherapy with epirubicin (60 mg/m² every other week) and vinorelbine (25 mg/m², weekly) plus granulocyte colony-stimulating factor (G-CSF) for 12 weeks, in patients with locally advanced breast cancer in a multicenter setting. Patients and Methods: Patients with stage IIIA or IIIB breast cancer, not older than 70, were eligible. A two-stage phase II design was applied. Response was assessed clinically, instrumentally and pathologically. Results: Out of 48 enrolled patients, 87.5% received all planned cycles, with a median dose-intensity of 30 mg/m²/week for epimbicin and 23.8 mg/m ²/week for vinorelbine. A clinical or instrumental objective response was reached in 42 patients (87.5%, exact 95% CI: 74.7-95.3); significant downstaging was reached in all but one patient; 6 cases had a pathological complete response in the breast, and 2 cases in the lymph nodes too (pathological complete response rate 4.2%, exact 95% CI: 0.5-14.2); a further 2 patients had only microscopic cancer foci at pathological examination of the breast. Radiological tests underestimated the treatment effect on the breast. Toxicity was mild, neutropenia being the most frequent (grade 3-4 in 47% of patients), but never complicated with fever or sepsis. Mild constipation (