Faculty Collaboration Database

Bicalutamide ('Casodex') 150 mg as adjuvant to radiotherapy in patients with localised or locally advanced prostate cancer: results from the randomised Early Prostate Cancer Programme. Radiother Oncol 2005 Jul;76(1):4-10

Date

09/08/2005

Pubmed ID

16145740

DOI

10.1016/j.radonc.2005.06.005

Scopus ID

2-s2.0-23244464659 (requires institutional sign-in at Scopus site)   61 Citations

Abstract

BACKGROUND AND PURPOSE: The ongoing Early Prostate Cancer (EPC) programme is assessing bicalutamide ('Casodex') 150 mg, either alone or as adjuvant to treatment of curative intent, in patients with localised or locally advanced prostate cancer (n=8113). This paper presents an exploratory analysis of the subgroup of the EPC programme who received radiotherapy with curative intent (n=1370) in order to determine the efficacy (in terms of progression-free survival [PFS]) and tolerability of bicalutamide 150 mg in this setting.

PATIENTS AND METHODS: 1370 patients with T1-4, MO, any N prostate cancer received bicalutamide 150 mg or placebo adjuvant to radiotherapy of curative intent. This analysis was undertaken at median 5.3 years' follow-up.

RESULTS: In patients with locally advanced disease (n=305), bicalutamide adjuvant to radiotherapy significantly increased PFS by 53% (event-time ratio 1.53; 95% confidence intervals [CI] 1.16, 2.02) compared with placebo and reduced the risk of disease progression by 42% (hazard ration [HR] 0.58; 95% CI 0.41, 0.84; P=0.00348). In these patients, objective progression was experienced by 33.5% of those randomised to bicalutamide versus 48.6% for those randomised to placebo. The between-group difference in patients with localised disease (n=1065) failed to reach statistical significance (HR 0.80; 95% CI 0.62, 1.03; P=0.088). The most common adverse events were breast pain (74.8%) and gynaecomastia (66.6%), which were mild to moderate in >90% of cases.

CONCLUSIONS: Bicalutamide 150 mg/day given as adjuvant to radiotherapy significantly improved PFS in patients with locally advanced prostate cancer. For patients with localised disease, the results at this stage from the radiotherapy subgroup and the overall EPC programme suggest that adjuvant hormonal therapy is currently not appropriate. There were no unexpected tolerability findings.

Author List

Tyrrell CJ, Payne H, See WA, McLeod DG, Wirth MP, Iversen P, Armstrong J, Morris C, 'Casodex' Early Prostate Cancer Trialists Group

MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Androgen Antagonists
Anilides
Antineoplastic Agents
Chemotherapy, Adjuvant
Disease Progression
Disease-Free Survival
Double-Blind Method
Humans
Male
Middle Aged
Nitriles
Prostatic Neoplasms
Radiotherapy
Tosyl Compounds