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A randomised comparison of bicalutamide ('Casodex') 150 mg versus placebo as immediate therapy either alone or as adjuvant to standard care for early non-metastatic prostate cancer. First report from the Scandinavian Prostatic Cancer Group Study No. 6.

https://arctichealth.org/en/permalink/ahliterature18881
Source
Eur Urol. 2002 Sep;42(3):204-11
Publication Type
Article
Date
Sep-2002
Author
P. Iversen
T L J Tammela
S. Vaage
O. Lukkarinen
P. Lodding
T. Bull-Njaa
J. Viitanen
P. Hoisaeter
P. Lundmo
F. Rasmussen
J-E Johansson
B-E Persson
K. Carroll
Author Affiliation
Department of Urology D-2112, University of Copenhagen, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. piv@rh.dk
Source
Eur Urol. 2002 Sep;42(3):204-11
Date
Sep-2002
Language
English
Publication Type
Article
Keywords
Aged
Aged, 80 and over
Anilides - adverse effects - therapeutic use
Antineoplastic Agents - adverse effects - therapeutic use
Chemotherapy, Adjuvant
Combined Modality Therapy
Double-Blind Method
Humans
Male
Middle Aged
Neoplasm Staging
Prostatic Neoplasms - drug therapy
Sexual Behavior - drug effects
Survival Analysis
Time Factors
Abstract
OBJECTIVES: To assess the efficacy and tolerability of bicalutamide 150 mg ('Casodex'(1)) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with early (T1b-T4, any N, M0) prostate cancer. METHODS: This randomised, double-blind study was conducted in the Nordic countries as part of the 'Casodex' Early Prostate Cancer programme. Patients received bicalutamide 150 mg (n=607) or placebo (n=611) in addition to standard care. RESULTS: More than 80% of patients had not received therapy of primary curative intent. Median follow-up in both groups was 3 years. Median exposure to study treatment in the bicalutamide and standard care alone groups was 2.5 and 2.3 years, respectively. Bicalutamide reduced the risk of objective disease progression by 57% compared with standard care alone (HR 0.43; 95% CI 0.34, 0.55; p
PubMed ID
12234503 View in PubMed
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