Ifosfamide, paclitaxel, and cisplatin for patients with advanced transitional cell carcinoma of the urothelial tract - Final report of a phase II trial evaluating two dosing schedules

BACKGROUND. A combination regimen of ifosfamide, paclitaxel, and cisplatin (ITP), recycled every 4 weeks, was reported in the treatment of previously untreated patients with advanced transitional cell carcinoma (TCC). This st udy sought to examine ITP at 3-week intervals to assess its feasibility and toxicity, compare the results for different schedules, and assess the impa ct of prognostic factors and postchemotherapy surgery on outcome. METHODS. ITP (ifosfamide 1.5 g/m(2) daily for 3 days, paclitaxel 200 mg/m(2 ) over 3 hours, and cisplatin 70mg/m(2) on Day 1) was administered to patie nts with metastatic or unresectable TCC and was recycled every 4 weeks (for 30 patients) or 3 weeks (for 15 patients). Granulocyte-colony stimulating factor was given during each cycle. RESULTS. Thirty of 44 assessable patients (68%; 95% confidence interval, 52 -81%) demonstrated a major response (10 complete responses [23%], 20 partia l [45%]), with durations of response ranging from 4 to 36 months. At a medi an follow-up of 28 months, the median survival was 20 months. Eleven patien ts (25%) were disease free at last follow-up. Overall toxicity for the 15 p atients whose treatment was recycled at 3 weeks was similar to that for pat ients treated every 4 weeks. Hematologic toxicity included anemia, thromboc ytopenia, and febrile neutropenia. Febrile neutropenia was observed in 7 pa tients (16%) and in 3.3% of cycles of therapy. No Grade 4 nonhematologic to xicity was observed. Grade 3 nonhematologic toxicity included alopecia, ren al insufficiency (11%), and neuropathy (9%). CONCLUSIONS. ITP is an active, well-tolerated regimen for previously untrea ted patients with TCC of the urothelial tract, resulting in a median surviv al of 20 months. Treatment can be recycled at 3-week intervals without enha nced toxicity. (C) 2000 American Cancer Society.