Phase II EORTC trial with 5-fluorouracil, cisplatin and interferon-alpha as second-line treatment of advanced transitional cell cancer of the urothelial tract

Background: Based on the favorable results of the combination 5-fluorouraci l (5-FU), cisplatin and interferon-alpha as second-line treatment in advanc ed metastatic transitional-cell carcinoma of the urothelial tract a confirm atory study was executed in a multicenter setting. Patients and methods: In this open label phase II study 43 patients failing adequate previous chemotherapy were treated with IFN-alpha 2b 5 MU/m(2) su bcutaneously for 5 consecutive days starting on day 1 and 22 simultaneous w ith 5-FU 500 mg/m(2) daily as a continuous infusion. In between the same do se of IFN-alpha 2b was given 3 times weekly with CDDP 25 mg/m(2) on days 1, 8, 15 and 22. This cycle was repeated every six weeks. Results: In 40 eligible patients 5 PR were seen (12.5%; 95% confidence inte rval (95% CI): 4.1%-26.8%). The major toxicity was hematological. Two toxic deaths were seen due to gastro-intestinal hemorrhage. Conclusions: In view of these results this combination can not be recommend ed as second line treatment for metastatic transitional-cell carcinoma of t he urothelial tract.