Long-term experience with flutamide in patients with prostatic carcinoma.

Fifty-two patients with previously untreated metastatic carcinoma of the prostate were treated with flutamide 250 mg tid. Response was classified according to objective and subjective criteria, and duration of response and total survival were chosen as endpoints. Disease manifestations at presentation and tumor burden were studied to determine their relationship, if any, to treatment response and outcome. Total survival was longest in 26 patients who had objective responses (mean 50 months). Patients who failed to respond (n = 13) and those who had subjective responses (n = 13) survived an average of eleven and 17.2 months, respectively. Tumor burden was correlated with response to treatment and total survival; those judged to have a minimum tumor burden had objective responses and survived an average of sixty months. Sixteen other patients who had been previously treated with diethylstilbestrol were also studied. Nine of these had cardiovascular complications while taking diethylstilbestrol, and tolerated flutamide without further complications. Those in remission stayed in remission, and sexual potency returned to 5 patients.