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Increased Dose Density Is Feasible: A Pilot Study of Adjuvant Epirubicin and Cyclophosphamide followed by Paclitaxel, at 10- or 11-Day Intervals with Filgrastim Support in Women with Breast Cancer

Authors' Affiliations: ¹ Breast Cancer Medicine Service, Division of Solid Tumor Oncology, Department of Medicine and ² Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York

Requests for reprints: Monica N. Fornier, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, Box 457, New York, NY 10021. Phone: 212-639-3107; Fax: 212-717-3619; E-mail: fornierm{at}mskcc.org.

Purpose: Because Cancer and Leukemia Group B 9741 trial showed a benefit for every 14-day administration of chemotherapy compared with every 21-day treatment, we hypothesized that even greater dose density would be more effective. We conducted a pilot trial to assess the feasibility of dose-dense chemotherapy consisting of a standard regime at 10- to 11-day intervals in the adjuvant/neoadjuvant setting. A 2-day window was allowed for scheduling logistics.

Experimental Design: Thirty-nine women with early-stage breast carcinoma were accrued from April 2004 to October 2004. Median age was 47 years (range, 26-67 years). Patients received therapy with 100 mg/m² epirubicin and 600 mg/m² cyclophosphamide (EC) q 10 to 11 days for four cycles followed by 175 mg/m² paclitaxel q 10 to 11 days for four cycles, all with filgrastim support (300 µg s.c. daily) from day 2 to 24 h before the next treatment.

Results: Thirty-five (90%) patients completed all planned therapy. The median intertreatment interval was 10 days (range, 8-28 days). Cycles (80.7%) were delivered at no more than 10- to 11-day intervals. There were five dose reductions of 25% for grade 3 nonhematologic toxicity in five patients. Six (16%) patients developed febrile neutropenia defined as temperature >38°C with absolute neutrophil count <1,000/µL. All febrile neutropenia was during therapy with EC. Other grade 3 toxicities included bone pain, hand and foot syndrome, neuropathy, mucositis, nausea, and vomiting.

Conclusions: Therapy with EC for four cycles followed by paclitaxel for four cycles at 10- to 11-day intervals is feasible. The 30% reduction in intertreatment interval compared with every 14-day treatment could increase the efficacy of adjuvant chemotherapy.