Fax: (734) 615-2719
Phase II trial of oral uracil/tegafur plus leucovorin in patients with hormone-refractory prostate carcinoma
Article first published online: 13 MAR 2006
Copyright © 2006 American Cancer Society
Volume 106, Issue 8, pages 1715–1721, 15 April 2006
How to Cite
Bhandari, M. S., Pienta, K. J., Fardig, J., Olson, K. and Smith, D. C. (2006), Phase II trial of oral uracil/tegafur plus leucovorin in patients with hormone-refractory prostate carcinoma. Cancer, 106: 1715–1721. doi: 10.1002/cncr.21815
- Issue published online: 4 APR 2006
- Article first published online: 13 MAR 2006
- Manuscript Accepted: 15 NOV 2005
- Manuscript Revised: 21 OCT 2005
- Manuscript Received: 29 JUL 2005
- National Cancer Institute
- National Institutes of Health. Grant Number: 2P30 CA 46592-14
- Bristol-Myers Squibb Oncology
- prostate carcinoma;
- hormone refractory
The current study evaluated the efficacy of oral uracil/tegafur (UFT) and leucovorin (LV) in patients with hormone-refractory metastatic prostrate carcinoma.
Twenty-eight patients with hormone-refractory metastatic carcinoma of the prostate who had undergone antiandrogen withdrawal and no more than 1 prior chemotherapy treatment were enrolled on a single-institution Phase II trial. Patients were treated with oral UFT at a dose of 300 mg/m2/d and oral LV at a dose of 90 mg/day for 28 days followed by 7 days off therapy on a 35-day cycle regimen.
Twenty-six patients were evaluable for response and toxicity. There was no response by objective criteria in 9 patients with measurable disease. Four responses by prostate-specific antigen (PSA) criteria (i.e., PSA decrease by > 50%) were noted (15%) lasting a mean of 20.5 weeks. Therapy was generally well tolerated, with 2 patients developing Grade 4 toxicity (1 patient each with diarrhea and hand-foot syndrome) and 4 patients having significant Grade 3 toxicity (anemia, hyperbilirubinemia, and vomiting) (Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria). Six patients had stable disease by clinical, laboratory, and radiologic criteria for an average of 5 cycles of treatment (25 wks).
Although UFT and LV are generally well tolerated in the setting of hormone-refractory metastatic prostate carcinoma, the combination has a low level of activity. Its toxicity and activity is similar to that observed when intravenous 5-fluorouracil or capecitabine are given alone. It may be an option for further investigations in combination regimens. Cancer 2006. © 2006 American Cancer Society.