ARTICLES Dose-Dense Adjuvant Chemotherapy in Early Breast Cancer Patients: Results From a Randomized Trial

Background: To determine whether a dose-dense regimen improves outcome in early breast cancer patients, we com-pared outcomes with the same fl uorouracil, epirubicin, and cyclophosphamide (FEC) chemotherapeutic regimen admin-istered every 3 weeks (FEC 21) or administered every 2 weeks (FEC 14 including support with fi lgrastim, a granulocyte colony-stimulating factor) in a multicenter phase III random-ized trial. Methods: A total of 1214 patients with early-stage breast cancer were randomly assigned to receive six cycles of FEC 14 (604 patients) or of FEC 21 (610 patients). Study end-points were overall survival and event-free survival. Associa-tions were assessed by multivariable analysis with adjustment for age; tumor size; grade; proliferative rate; and menopausal, lymph node, estrogen receptor, and progesterone receptor status. All statistical tests were two-sided. Results: Patients i