Emerging role of adjuvant hormonal therapy

Recent years have seen a downward shift in the most common disease stage at diagnosis and in the age of patients diagnosed with prostate cancer. Although younger men with clinically localized disease are generally offered radiotherapy or radical prostatectomy, such treatment does not always produce a cure. Adjuvant hormonal therapy (medical or surgical castration) has been shown to extend progression-free survival in both the radiotherapy and surgical settings, and overall survival benefits have also been demonstrated in some studies. However, castration is associated with sexual dysfunction that may be unacceptable, particularly among younger patients. The ongoing bicalutamide (Casodex; AstraZeneca Pharmaceuticals, Wilmington, DE) Early Prostate Cancer program is evaluating the efficacy and tolerability of bicalutamide 150 mg as immediate therapy, either alone or as an adjuvant to therapy of curative intent, in patients with localized or locally advanced prostate cancer. This is the largest clinical trial program in prostate cancer treatment to date, comprising 3 randomized, double-blind, placebo-controlled studies with a total of 8113 patients. At median follow-up period of 3 years and after 922 progression events, the bicalutamide group had a significant reduction of 42% in the risk of objective progression compared with patients who received placebo plus standard care. The risk of prostate-specific antigen progression was also significantly reduced by 59%. As expected, gynecomastia and breast pain were the most frequently reported side effects of bicalutamide therapy. A longer follow-up period will determine whether the reduced risk of progression will translate into cause-specific and overall survival benefit for these patients.