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Bicalutamide
See also Antiandrogens
General information
Mason has reviewed the role of antiandrogens in the treatment of prostate cancer, arguing that with earlier initiation of therapy the long-term adverse effects of castration need to provide the standard by which the acceptability of drugs such as bicalutamide is judged [ ]. There is now evidence that bicalutamide confers significant overall survival benefit when used as an adjuvant to radiotherapy in patients with locally advanced disease. However, the survival data for bicalutamide are not as extensive as those available for LHRH agonists. Although they do not appear to have a significant impact on sexual and physical activity, non-steroidal antiandrogens are often associated with gynecomastia and breast pain, and some are associated with diarrhea.
Observational studies
Prostate cancer
The effect of adding finasteride 5 mg/day to high-dose bicalutamide 150 mg/day has been studied in 41 men with advanced prostate cancer treated over a mean of 3.9 years [ ]. The serum prostate-specific antigen (PSA) concentration was measured every 2 weeks until disease progression. At the first nadir of PSA, the median fall from baseline was 96.5%; a second nadir occurred in 30 of 41 patients, with a median fall of 98.5% from baseline. The median times to each nadir were 3.7 and 5.8 weeks respectively. The median time to treatment failure was 21 months. Adverse effects were minor, including gynecomastia. Sex drive was normal in 17 of 29 men at baseline and in 12 of 24 men at the second PSA nadir, but one-third of the men had spontaneous erections at both times. The authors concluded that finasteride provided additional intracellular androgen blockade when added to bicalutamide. The duration of control was comparable to that achieved with castration, with preserved sexual function in some patients.
The third analysis of the bicalutamide Early Prostate Cancer (EPC) programme was published in 2006 and essentially confirmed earlier impressions of the acceptable benefit to harm balance of this compound in early prostate cancer treatment [ , ], as have other studies. A typical dose is 150 mg/day. However, much depends on the regimen that is used and the state of progression of the disorder.
Placebo-controlled studies
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