Phase II trial of oral uracil/tegafur plus leucovorin in patients with hormone-refractory prostate carcinoma.

Background: The current study evaluated the efficacy of oral uracil/tegafur (UFT) and leucovorin (LV) in patients with hormone-refractory metastatic prostate carcinoma.

Methods: 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.

Should intermittent androgen deprivation be used in routine clinical practice?

For several decades, androgen deprivation (AD) has been the mainstay for treating metastatic prostate cancer. AD can be attained by a variety of means; however, irrespective of modality and a gratifying initial high response rate, almost all patients advance to a state of androgen independence and ultimately a hormone-refractory state. Improved understanding of the biology and mechanisms of progression to androgen independence coupled with promising preclinical data have led to investigating intermittent AD (IAD) as a way of improving disease control while maintaining quality of life.

Clinical trials in metastatic prostate cancer--has there been real progress in the past decade?

Hormone refractory prostate cancer remains a challenge. While only palliative treatment strategies were available for the past several decades, many promising agents have been investigated over the past decade. Of those the taxanes appeared with significant anti-tumor activity and recently, two large randomized controlled trials demonstrated for the first time, a survival and palliative benefit with docetaxel based chemotherapy.