Complete androgen blockade as treatment for advanced prostate cancer: clinical response and side-effects.

Treatment of advanced prostatic cancer is currently based on hormonal manipulation. In 1982 Labrié supported a new concept of hormonal treatment based on complete androgen blockade. The objective of this study was to evaluate the effects of total androgen suppression, achieved by the combination of a LHRH agonist (buserelin) plus a pure anti-androgen (flutamide) in the long-term treatment of advanced prostate cancer. Forty-seven untreated consenting patients with advanced prostatic cancer entered in the study, and 41 of these proved evaluable for response and toxicity. Buserelin and Flutamide were administered three times daily, intranasally and orally respectively, at a dose of 1.2 mg and 750 mg for twelve months. Circulating testosterone levels, regularly measured during the study, were reduced by the treatment to castrated levels. Clinical results are encouraging for the high rate of objective and clinical responses PR + SD = 37 (90%), for its duration (12 months), for the significant improvement of urological symptoms and for the decrease of cancer-related pain, even in cases with detectable bone metastases. Compliance was excellent in all the subjects and no patient was forced to interrupt treatment because of cardiovascular toxicity or severe side-effects, which were limited to occasional loss of libido and potency, hot-flashes, mild diarrhea and nausea.