A COMPARATIVE, RANDOMIZED TRIAL OF UFT(R) AND 5-FLUOROURACIL IN COMBINATION WITH CYCLOPHOSPHAMIDE AND DOXORUBICIN IN THE TREATMENT OF ADVANCED BREAST-CANCER PATIENTS AT THE PHILIPPINES GENERAL-HOSPITAL

A comparative, randomized trial was conducted to determine the efficac y of oral UFT(R) (Tegafur and Uracil) versus 5-fluorouracil (5-FU) in combination with cyclophosphamide and doxorubicin in patients with met astatic breast cancer. Of 62 evaluable patients, 31 received UFT(R) (3 50 mg/m(2)/day orally x 14 days), doxorubicin (50 mg/m(2) intravenousl y [IV] day 1) and cyclophosphamide (500 mg/m(2) IV day 1). The other 3 1 patients received 5-FU (500 mg/m(2) IV days 1 and 8), doxorubicin (5 0 mg/m(2) IV day 1), and cyclophosphamide (500 mg/m(2) IV day 1), Regi mens were repeated for a total of six cycles. The two groups were comp arable in terms of age, gender, performance status, menopausal status, and number and sites of metastases. No statistical difference in over all response rates was seen (UFT(R) arm, 48.4% vs. 5-FU arm, 35%; p = 0.30). Median response duration was 16 weeks (range, 4-30) for both ar ms. The toxicity profile (alopecia, anemia, leukopenia, thrombocytopen ia, diarrhea) was similar in both groups and both regimens were well t olerated. Anemia and stomatitis were significantly mure common in the 5-FU arm (p = 0.02). Thus, oral UFT(R) has response rates and duration of response that are comparable to 5-FU in a combination regimen for advanced breast cancer.