Abstract
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.
Original language | English |
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Pages (from-to) | 1391-1394 |
Number of pages | 4 |
Journal | Annals of Oncology |
Volume | 11 |
Issue number | 11 |
DOIs | |
State | Published - 2000 |
Externally published | Yes |
Keywords
- Chemotherapy
- Interferon
- Transitionall-cell carcinoma
- Urothelial tract