RT Journal Article SR Electronic T1 Primary Chemotherapy with Epirubicin and Vinorelbine in Women with Locally Advanced Breast Cancer JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 1343 OP 1348 VO 25 IS 2B A1 CECILIA NISTICÒ A1 ANDREA DE MATTEIS A1 EMANUELA ROSSI A1 FLAVIO CARNINO A1 ROBERTO VALENZA A1 BIAGIO AGOSTARA A1 EMILIO BRIA A1 ANTONIO FARRIS A1 MARCO CREMONESI A1 ANNA MARIA D'OTTAVIO A1 ANGELA VACCARO A1 CARLO GARUFI A1 SALVATORE GIUNTA A1 CLAUDIO BOTTI A1 FRANCESCO PERRONE A1 EDMONDO TERZOLI YR 2005 UL http://ar.iiarjournals.org/content/25/2B/1343.abstract AB 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 epirubicin and 23.8 mg/m2/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 (≤grade 2) occurred in 35% of patients. Moderate to severe asthenia occurred in 12% of 6 patients. No cardiac toxicity was reported. At 3 years, disease-free survival was 68% and overall survival 81%. Conclusion: Primary chemotherapy with epirubicin every other week, weekly vinorelbine and G-CSF support is highly active and well tolerated in patients with locally advanced breast cancer. Copyright© 2005 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved