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).
D000368:Aged; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D006801:Humans; D008875:Middle Aged; D011379:Prognosis; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality
D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin