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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.

journal_name

BJU Int

journal_title

BJU international

authors

Serretta V,Daricello G,Dispensa N,Allegro R,Pavone C,Pavone-Macaluso M

doi

10.1046/j.1464-410x.2003.04413.x

keywords:

subject

Has Abstract

pub_date

2003-10-01 00:00:00

pages

545-49; discussion 549-50

issue

6

eissn

1464-4096

issn

1464-410X

pii

4413

journal_volume

92

pub_type

临床试验,杂志文章

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