Phase III comparison of cisplatin alone versus cisplatin, doxorubicin and cyclophosphamide in the treatment of bladder (urothelial) cancer: a Southeastern Cancer Study Group trial.

A prospective randomized trial compared cisplatin alone versus cisplatin, doxorubicin and cyclophosphamide in the treatment of advanced carcinoma of the bladder, ureter and renal pelvis. Objective responses were noted in 7 of 45 patients (16 per cent) given cisplatin alone and in 9 of 42 (21 per cent) treated with the combination. There was no significant difference in response rate, response duration or survival but the combination was more toxic. Other combination regimens should be evaluated.