Phase II trial of sequentially administered cisplatin, cyclophosphamide and doxorubicin for urothelial tract tumors.

A total of 32 patients with urothelial tract tumors, 31 of whom had bidimensionally measurable disease parameters, underwent sequential intravenous administration of 70 mg./m.2 cisplatin, 250 mg./m.2 cyclophosphamide and 45 mg./m.2 doxorubicin on days 1 to 3 every 3 to 4 weeks. Of these patients 28 (88 per cent) were treated adequately, including 13 (46 per cent, 95 per cent confidence limits of 28 to 64 per cent) who achieved a complete (2) or partial (11) remission. Almost all remissions occurred within 1 to 3 weeks and persisted for a median duration of 8 months (range 4 to 16 months), with 5 patients responding for 1 or more years. Responders lived significantly longer than nonresponders, with a median of 91 versus 38 weeks, respectively (p less than 0.001). The over-all response rate with this 3-drug combination was not statistically different from that which has been observed in previously untreated, selected patients given cisplatin only. When the results of the 3-drug combination (92 responses in 202 patients) are compared to those of cisplatin alone (85 responses in 255 patients) the 3-drug regimen is statistically superior (p less than 0.002).