Phase I/II study of weekly paclitaxel (P), UFT and leucovorin in patients with metastatic breast cancer (MBC)

726 Background: Weekly P is active against MBC and may be more efficacious than P given every 3 weeks. UFT is a combination of uracil and tegafur which is a pro-drug of 5-FU and is commonly used in patients with MBC outside USA. We designed a sequential weekly therapy of P and UFT/leucovorin (LV) to explore potential synergistic effect. Methods: In phase I we studied a fixed dose of P (80mg/m2) I.V. day 1 and escalated doses of UFT (125, 150, 175 mg/m2) with LV 30 mg p.o. bid on days 2 to 6 weekly for 3 weeks. Cycle repeats every 4 weeks. The Phase II study started after MTD of UFT was established and response was evaluated every 2 cycles and toxicity weekly. Eligibility criteria included no prior chemotherapy for measurable MBC, ECOG PS ≤ 2 and adequate organ functions. Results: Total of 53 patients has been entered: 16 in phase I, and 37 in phase II. Phase I study established MTD of UFT to be 300mg/m2. The dose limiting toxicities were diarrhea, neutropenic fever and fatigue. The efficacy of both phase ...