UFT plus oral calcium folinate/vinorelbine for advanced breast cancer.

This phase I study was undertaken to define the maximum tolerated dose, dose-limiting toxicity, and recommended dosage of UFT (uracil and tegafur) plus oral calcium folinate (Orzel) and vinorelbine (Navelbine) in combination treatment of metastatic breast cancer in patients who have received one prior chemotherapy regimen. The pharmacokinetics of UFT and vinorelbine were also evaluated. Starting doses were UFT 300 mg/day, plus a fixed calcium folinate dose of 90 mg/day, both administered in three divided daily doses on days 1 through 21 and vinorelbine 15 mg/m2 on days 1, 8, and 15. The regimen was repeated every 4 weeks. At least three patients were treated at each dose level before escalating to the next level. Prophylactic granulocyte colony-stimulating factor was not routinely given. The preliminary results are reported as we await further follow-up of this ongoing study.