PMID: 7536271May 1, 1995Paper

The results of a phase II randomized trial comparing 5-fluorouracil and 5-fluorouracil plus alpha-interferon: observations on the design of clinical trials for androgen-independent prostate cancer

The Journal of Urology
D D DalianiChristopher Logothetis

Abstract

The therapeutic benefit of chemotherapy in androgen independent prostate cancer is limited. 5-Fluorouracil has been reported to have modest antitumor activity in androgen independent prostate cancer. Although alpha-interferon is inactive as a single agent in prostate cancer, preclinical data indicate that it increases the in vitro cytotoxicity of 5-fluorouracil against a variety of malignant cells. We evaluated the relative antitumor activity and tolerance of 5-fluorouracil versus 5-fluorouracil plus alpha-interferon in 50 patients with histologically confirmed metastatic adenocarcinoma of the prostate. These patients had progressive disease in the presence of castrate levels of testosterone. A prospective randomized phase II open labeled trial was performed because of the difficulty in measuring responses in patients with metastatic prostate cancer. Of 23 patients treated with 5-fluorouracil alone and 28 treated with 5-fluorouracil plus alpha-interferon 17 and 23, respectively, were evaluable for response and toxicity, and 5 and 5, respectively, were evaluable for toxicity only. Only 2 of 17 (11.7%) and 4 of 23 (17%) patients, respectively, showed a greater than 50% decrease in serum prostate specific antigen (no significant d...Continue Reading

References

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Citations

Sep 9, 1996·Journal of Immunological Methods·A R Mire-SluisR Thorpe
Apr 20, 2004·Cryobiology·John G BaustRobert Van Buskirk
Nov 15, 2002·Molecular and Cellular Endocrinology·R J A van Moorselaar, E E Voest
Oct 21, 2006·The Cochrane Database of Systematic Reviews·Mike ShelleyMalcolm D Mason

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