Abstract | PURPOSE: MATERIALS AND METHODS: A total of 1,218 men with T1-4, M0, any N prostate cancer were recruited from 62 Scandinavian centers and randomized 1:1 to 150 mg bicalutamide or placebo plus standard care. Primary end points were progression-free survival (PFS) and overall survival. RESULTS: At a median 5.3-year followup patients with locally advanced disease had improved survival with bicalutamide (HR 0.68, 95% CI 0.50 to 0.92), while those with localized disease had decreased survival with bicalutamide (HR 1.47, 95% CI 1.06 to 2.03). Bicalutamide significantly improved PFS, decreasing the risk of disease progression by 43% compared with placebo (HR 0.57, 95% CI 0.48 to 0.68, p<0.0001). The rate of events was 35.4% for bicalutamide and 46.2% for placebo. Patients with locally advanced disease gained the greatest PFS benefits with bicalutamide (HR 0.40, 95% CI 0.31 to 0.52). Since 81% of the trial population were untreated before entry and would otherwise have undergone WW, the findings essentially reflect the results of immediate hormone therapy vs WW. CONCLUSIONS:
Bicalutamide (150 mg) provides significant benefit in patients with locally advanced disease. In previously untreated patients there may be a tumor burden below which endocrine therapy provides no benefit or may even decrease survival.
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Authors | Peter Iversen, Jan-Erik Johansson, Pär Lodding, Olavi Lukkarinen, Per Lundmo, Peter Klarskov, Teuvo L J Tammela, Ilker Tasdemir, Tom Morris, Kevin Carroll, Scandinavian Prostatic Cancer Group |
Journal | The Journal of urology
(J Urol)
Vol. 172
Issue 5 Pt 1
Pg. 1871-6
(Nov 2004)
ISSN: 0022-5347 [Print] United States |
PMID | 15540741
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anilides
- Antineoplastic Agents
- Nitriles
- Tosyl Compounds
- bicalutamide
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Topics |
- Aged
- Aged, 80 and over
- Anilides
(administration & dosage)
- Antineoplastic Agents
(administration & dosage)
- Chemotherapy, Adjuvant
- Double-Blind Method
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Nitriles
- Prospective Studies
- Prostatic Neoplasms
(drug therapy)
- Survival Rate
- Time Factors
- Tosyl Compounds
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