PHASE-II STUDY OF 5-FLUOROURACIL AND ADRIAMYCIN IN TRANSITIONAL CELL-CARCINOMA OF THE URINARY-TRACT

Abstract

A prospective study was carried out to determine the effectiveness and tolerance of the combination of 5-fluorouracil (600 mg/m2) and adriamycin (50 mg/m2) given i.v. every 3 wk to patients with disseminated transitional cell carcinoma of the urinary tract. Of 23 patients entered in the study, 21 were evaluable for both response and toxicity. Two patients had complete responses and 6 had partial responses (.gtoreq. 50% reduction), yielding an overall response rate (complete plus partial) of 38%. Leukopenia (72.7%) and thrombocytopenia (54.5%) were common. Toxicity was life-threatening in 1 patient. Other common side effects were alopecia, nausea, vomiting and a generalized feeling of weakness. Responders had median survival time of 29 wk compared to a median survival time of 9 wk for nonresponders.