Adjuvant Treatment With Bicalutamide In The N American Cohort Of The Early Prostate Cancer Trial Demonstrates No Benefit At 7.7 Years Follow-Up

The Early Prostate Cancer Trial (EPC) consisted of three international groups of patients treated with either placebo or bicalutamide in addition to standard of care. The US cohort of men primarily chose radical prostatectomy (80%) as their standard of care. Most men were in the low risk category and evidence of positive lymph nodes or metastasis was exclusion criteria.

Participants were evaluated for prostate cancer (CaP) status at trial entry and every 3 months thereafter or until disease progression. The primary trial endpoints were progression-free survival (PFS) and overall survival (OS).

A total of 3,292 men were recruited in the North American trial. Median follow-up for this analysis was 7.7 years. The median duration of therapy was 1.83 years for bicalutamide and 1.84 years for placebo (standard of care alone). There was no difference in objective progression in men treated with bicalutamide vs. placebo with the rates of objective progression 15.4% and 15.3%, respectively. Mortality rates were 12.9% in the bicalutamide patients and 12.3% in the standard of care alone patients. No differences in PFS or OS were found between the two groups. However, bicalutamide improved the time to PSA progression.

Gynecomastia was experienced in 73% and breast pain in 85% of patients treated with bicalutamide. Withdrawal rates for this were 29%, compared to 0.9% in the placebo group. These data do not support a role for adjuvant bicalutamide in this group of patients.

By Christopher P. Evans, M.D.

J Urol 2006;176:75-80.
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