Faculty Collaboration Database

Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer. BJU Int 2006 Feb;97(2):247-54

Date

01/25/2006

Pubmed ID

16430622

DOI

10.1111/j.1464-410X.2005.06051.x

Scopus ID

2-s2.0-33644857333 (requires institutional sign-in at Scopus site)   254 Citations

Abstract

OBJECTIVE: To evaluate, in the ongoing Early Prostate Cancer (EPC) trial programme, the efficacy and tolerability of bicalutamide 150 mg once daily in addition to standard care for localized or locally advanced, nonmetastatic prostate cancer.

PATIENTS AND METHODS: The EPC programme comprises three randomized, double-blind, placebo-controlled trials designed for combined analysis. Following standard care, 8113 men with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N+) prostate cancer (all M0) received oral bicalutamide 150 mg once daily or oral placebo. The primary endpoints were progression-free survival (PFS) and overall survival.

RESULTS: The large EPC trial programme is defining men who benefit or do not from early or adjuvant antiandrogen therapy. At a median follow-up of 7.4 years, in localized disease there is no benefit to PFS by adding bicalutamide to standard care, and there is a trend (hazard ratio, HR, 1.16; 95% confidence intervals, CI, 0.99-1.37; P = 0.07) towards decreased survival in patients otherwise undergoing watchful waiting. However, in locally advanced disease, bicalutamide significantly improved PFS irrespective of standard care. Bicalutamide significantly improved overall survival in patients receiving radiotherapy (HR 0.65; 95% CI 0.44-0.95; P = 0.03); this was driven by a lower risk of prostate cancer-related deaths. Bicalutamide produced a trend towards improved overall survival in patients with locally advanced disease otherwise undergoing watchful waiting (HR 0.81; 95% CI 0.66-1.01; P = 0.06). No survival difference was evident in the prostatectomy subgroup.

CONCLUSIONS: This ongoing programme is clarifying the role of early or adjuvant antiandrogen therapy in prostate cancer. Patients with localized disease do not appear to derive clinical benefit from added bicalutamide. However, adding bicalutamide 150 mg to standard care provides significant clinical benefits in patients with locally advanced prostate cancer, irrespective of primary therapy.

Author List

McLeod DG, Iversen P, See WA, Morris T, Armstrong J, Wirth MP, Casodex Early Prostate Cancer Trialists' Group

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

Aged
Androgen Antagonists
Anilides
Chemotherapy, Adjuvant
Combined Modality Therapy
Disease Progression
Disease-Free Survival
Double-Blind Method
Humans
Male
Neoplasm Staging
Nitriles
Prostatectomy
Prostatic Neoplasms
Survival Analysis
Tosyl Compounds