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

P. H.M. De Mulder, C. Theodore, A. Sella, O. Koriakine, C. N. Sternberg, L. Collette, C. De Balincourt

Research output: Contribution to journalArticlepeer-review

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 languageEnglish
Pages (from-to)1391-1394
Number of pages4
JournalAnnals of Oncology
Volume11
Issue number11
DOIs
StatePublished - 2000

Keywords

  • Chemotherapy
  • Interferon
  • Transitionall-cell carcinoma
  • Urothelial tract

Fingerprint

Dive into the research topics of 'Phase II EORTC trial with 5-fluorouracil, cisplatin and interferon-α as second-line treatment of advanced transitional cell cancer of the urothelial tract'. Together they form a unique fingerprint.

Cite this