Long‐term outcome of antiandrogen monotherapy in advanced prostate carcinoma: 12‐year results of a phase II study

Abstract

OBJECTIVE To present the long‐term outcome of patients with locally advanced or metastatic prostate carcinoma treated by first‐line antiandrogen monotherapy. PATIENTS AND METHODS From 1983 to 1990, 41 patients with advanced prostate carcinoma were treated with flutamide monotherapy until progression or the appearance of toxicity. Twenty‐five patients (61%) had T3‐T4N0M0 and 16 (39%) T2–4N0–3M1 prostate carcinoma. Consensus criteria were adopted to evaluate the response. Plasma testosterone and sexual function were recorded for the first 3 years. RESULTS Flutamide was administered for up to 147 months; seven patients (17%) interrupted the treatment because of toxicity. There was an objective response in 17 (41%) patients; 20 (49%) had stable disease while four (10%) progressed. There were objective responses, lasting up to 150 months, in 82% of those with M0 and in 18% with M1 disease (P = 0.05). The median time to progression in patients with an objective response and stable disease was 45 and 16 months, respectively (P < 0.001). Thirty‐one patients (76%) died from prostate cancer and 10 (24%) from unrelated diseases. The median survival was 67 and 36 months in patients with an objective response and stable disease, respectively (P < 0.001). There was an improvement in performance status in 85% and reduction in bone pain in 83% of the patients; sexual activity was maintained in 63%. CONCLUSION Monotherapy with flutamide is well tolerated. Objective responses are more frequent in patients with locally advanced disease. Patients with an objective response within 6 months have a prolonged progression‐free and overall survival.