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

Background: Based on the favorable results of the combination 5-fluorouracil (5-FU), cisplatin and interferon-α as second-line treatment in advanced metastatic transitional-cell carcinoma of the urothelial tract a confirmatory 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-α2b 5 MU/m² subcutaneously for 5 consecutive days starting on day 1 and 22 simultaneous with 5-FU 500 mg/m² daily as a continuous infusion. In between the same dose of IFN-α2b was given 3 times weekly with CDDP 25 mg/m² 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 interval (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 recommended as second line treatment for metastatic transitional-cell carcinoma of the urothelial tract.