A Comparative, Randomized Trial of UFT® and 5-Fluorouracil in Combination with Cyclophosphamide and Doxorubicin in the Treatment of Advanced Breast Cancer Patients at The Philippines General Hospital

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Abstract
A comparative, randomized trial was conducted to determine the efficacy of oral UFT® (Tegafur and Uracil) versus 5-fluorouracil (5-FU) in combination with cyclophosphamide and doxorubicin in patients with metastatic breast cancer. Of 62 evaluable patients, 31 received UFT® (350 mg/m2/day orally x 14 days), doxorubicin (50 mg/m2 intravenously [IV] day 1) and cyclophosphamide (500 mg/m2 IV day 1). The other 31 patients received 5-FU (500 mg/m2 IV days 1 and 8), doxorubicin (50 mg/m2 IV day 1), and cyclophosphamide (500 mg/m2 IV day 1). Regimens were repeated for a total of six cycles. The two groups were comparable in terms of age, gender, performance status, menopausal status, and number and sites of metastases. No statistical difference in overall response rates was seen (UFT® arm, 48.4% vs. 5-FU arm, 35%; p = 0.30). Median response duration was 16 weeks (range, 4–30) for both arms. The toxicity profile (alopecia, anemia, leukopenia, thrombocytopenia, diarrhea) was similar in both groups and both regimens were well tolerated. Anemia and stomatitis were significantly more common in the 5-FU arm (p = 0.02). Thus, oral UFT® has response rates and duration of response that are comparable to 5-FU in a combination regimen for advanced breast cancer.

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