A dose escalation trial of adjuvant cyclophosphamide and epirubicin in combination with 5-fluorouracil using G-CSF support for premenopausal women with breast cancer involving four or more positive nodes

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BackgroundDose-dense and dose-intensive regimens have improved the outcome of breast cancer in high-risk women with operable disease.Patients and methodsSixty-three premenopausal women with Stage 2, 3 breast cancer and ≥4 positive axillary nodes were treated in three successive cohorts with 70 mg/m2 of epirubicin, 500 mg/m2 of 5-fluorouracil and G-CSF every 14 days for 12 cycles. Cyclophosphamide (C) was given at 700 mg/m2, 900 mg/m2, and 1100 mg/m2 doses. Patients were evaluated for dose-limiting toxicities (DLTs) in the first four cycles, the primary endpoint of the trial.ResultsNo DLTs were seen at C 700 mg/m2; at C 900 mg/m2 two of 16 patients experienced febrile neutropenia and poor performance status; at C 1100 mg/m2, 1 of 31 patients experienced poor performance status. Over 6 months, febrile neutropenia, grade 4 thrombocytopenia, grade 3 anemia and severe fatigue were observed. Clinical congestive heart failure occurred in three patients over 4 years.ConclusionA dose-intense and dose-dense regimen of cyclophosphamide, epirubicin and 5-fluorouracil was delivered with G-CSF without apparent increase in acute toxicity. Cyclophosphamide could be increased to more than twice the standard dose at the cost of more anemia and fatigue.

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