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Annals of Oncology 11:1391-1394, 2000
© 2000 European Society for Medical Oncology

research-article

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

P. H. M. De Mulder1,, C. Theodore2, A. Sella3, O. Koriakine4, C. N. Sternberg5, L. Collette6 and C. de Balincourt6

1Department of Medical Oncology, University Hospital Nijmegen Nijmegen, The Netherlands
2Institut Gustave Roussy, Service de Medicine Villejuif, France
3Beilinson Medical Center, The Sackler School of Medicine, Tel Aviv University Petah-Tikva, Israel
4Medical Radiological Research Center, Department of Urology Obninsk Kaluga Region, Russia
5Foundation Vincenzo Pansodoro, PIOXI Rome, Italy
6EORTC Data Center Brussels, Belgium

Correspondence to: Prof. P. H. M. De Mulder, MD, PhD Department of Medical Oncology University Hospital Nijmegen P.O. Box 9101 6500 HB Nijmegen The Netherlands E-mail: p.demulder{at}onco.azn.nl

BACKGROUND: Based on the favorable results of the combination 5-fluorouracil (5-FU), cisplatin and interferon-{alpha} 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-{alpha}2b 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-{alpha}2b 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 gastrointestinal 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.

chemotherapy, interferon, transitionall-cell carcinoma, urothelial tract


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