Group A, FECStandard(standard FEC) is given 7 courses of 5-fluorouracil-epirubicin (Farmorubicin)-cyclophosphamide with doses based on the patient's surface area. Leukocyte nadir values at day 10, 12 or 13 and 15 are measured. Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia.
Group B FECTailored(Tailored FEC) receives course one at identical doses to group A. Leukocyte nadir values at day 10,12 or 13 and 15 are measured. Doses of subsequent courses are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients experiencing only grade 0 to 2 leukopenia after course one.
Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia .
Patients achieving only grade 0-2 leukopenia at the first course will be randomized into continued treatment at standard doses (Group A) or to doses tailored to achieve grade 3 leukopenia (Group B). The primary comparisons will be made between these two groups of patients.
Patients with grade 3-4 leukopenia after the first course not be randomized but followed according to the protocol and received treatment as group A, FECStandard.
