Prolonged Dose-Dense Epirubicin and Cyclophosphamide Followed by Paclitaxel in Breast Cancer Is Feasible

PurposeWe conducted a pilot study of dose-dense epirubicin/cyclophosphamide (EC) × 6 → paclitaxel (P) × 6 with pegfilgrastim. A previous dose-dense trial of FEC (5-fluorouracil [5-FU]/EC) × 6 with filgrastim → by weekly paclitaxel alternating with docetaxel × 18 was not feasible because of pneumonitis (with dose-dense FEC) and pericardial/pleural effusion (taxane phase). Dose-dense EC (without the 5-FU) is not associated with pneumonitis, and dose-dense paclitaxel (alone) is feasible. Primary objective was feasibility.Patients and MethodsPatients with resectable breast cancer were enrolled, regardless of surgery status, tumor size, or nodal status. Treatment regimen consisted of every-2-week EC (100/600 mg/m2) × 6 → by 2-weekly P (175 mg/m2) × 6 with pegfilgrastim 6 mg on day 2.ResultsBetween November 2004 and May 2005, 38 patients were enrolled. The median age was 47 years (range, 30-72 years); 33 of 38 (87%) were treated in the adjuvant setting and 27 of 33 (81%) had involved nodes (range, 1-46); 5 of 38 (13%) were treated pre-operatively; 33 of 38 (87%) completed all chemotherapy as planned; the remaining patients (13%) had treatment modifications for toxicity. Febrile neutropenia occurred in 6 of 38 patients (16 %) and only during EC. There were 12 hospitalizations in 9 of 38 patients (24%) enrolled.ConclusionDose-dense every-2-week EC × 6 → P × 6 with pegfilgrastim is feasible based on our prospective definition.