Jacques M. Bonneterre, MD, PhD

Adjuvant chemotherapy has been shown to be beneficial in patientswith breast cancer, and anthracycline-containing regimens are more effectivethan non–anthracycline-containing ones. The French AdjuvantStudy Group (FASG) compared FEC100 and FEC50 (fluorouracil[5-FU]/epirubicin [Ellence]/cyclophosphamide [Cytoxan, Neosar])in patients with node-positive breast cancer, with an end point of overallsurvival. After a median follow-up of 10 years, the benefit/risk ratio of theFEC100 regimen in patients with positive axillary nodes is strongly positive.Furthermore, a medicoeconomic study showed that the cost per yearof life saved was very low-approximately 1,000 euros.

This phase I study was undertaken to define the maximum tolerated dose, the dose-limiting toxicity, and the recommended dose of UFT plus leucovorin and vinorelbine in combination treatment of patients with metastatic breast cancer previously treated with one chemotherapy regimen. The pharmacokinetics of UFT and vinorelbine were also evaluated.