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Merck

Bicalutamide monotherapy for early stage prostate cancer: an update.

The Journal of urology (2003-11-12)
Peter Iversen
ABSTRACT

The current evidence is considered to support 150 mg of the nonsteroidal antiandrogen bicalutamide for early stage prostate cancer. Data from phase III trials of 150 mg bicalutamide monotherapy for locally advanced disease are discussed. In addition, the first overall results are examined from the bicalutamide early prostate cancer program conducted at a median followup of 3 years, in which patients with localized or locally advanced disease were randomized to receive 150 mg bicalutamide or placebo as well as standard care. Mature data from phase III studies have shown that 150 mg bicalutamide monotherapy provide similar survival outcome to that observed with castration in patients with locally advanced (M0) disease. Moreover, 150 mg bicalutamide have benefits over castration in terms of quality of life, particularly sexual interest and physical capacity, and preservation of bone mineral density. In the bicalutamide early prostate cancer program 150 mg significantly reduced the risk of objective progression in patients with localized or locally advanced disease at 3 years of median followup, with the greatest benefit seen in patients with poorer prognosis. Followup is ongoing to further determine the benefit of 150 mg bicalutamide in early prostate cancer. Bicalutamide is emerging as a useful treatment option for early prostate cancer.

MATERIALS
Product Number
Brand
Product Description

Bicalutamide, European Pharmacopoeia (EP) Reference Standard
Bicalutamide for system suitability, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Bicalutamide (CDX), ≥98% (HPLC), powder