Phase II Trial of Sequentially Administered Cisplatin, Cyclophosphamide and Doxorubicin for Urothelial Tract Tumors

Abstract

A total of 32 patients with urothelial tract tumors, 31 of whom had bidimensionally measurable disease parameters, underwent sequential i.v. administration of 70 mg/m2 cisplatin, 250 mg/m2 cyclophosphamide and 45 mg/m2 doxorubicin on days 1 to 3 every 3-4 wk. Of these patients, 28 (88%) were treated adequately, including 13 (46%, 95% confidence limits of 28-64%) who achieved a complete (2) or partial (11) remission. Almost all remissions occurred within 1-3 wk and persisted for a median duration of 8 mo. (range 4-16 mo.), with 5 patients responding for 1 yr. Responders lived significantly longer than nonresponders, with a median of 91 vs. 38 wk, respectively (P < 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 < 0.002).