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J Urol. 1997 Jul;158(1):160-3.

Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group.

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1
Department of Urology, University Hospital Nijmegen, The Netherlands.

Abstract

PURPOSE:

We studied the long-term efficacy and tolerability of nilutamide, a nonsteroidal antiandrogen, combined with orchiectomy in patients with advanced prostate cancer.

MATERIALS AND METHODS:

A large double-blind trial was done on 457 patients randomized to receive nilutamide or placebo after orchiectomy.

RESULTS:

At 8.5 years of followup significant benefits were found for progression and survival in favor of patients receiving nilutamide and orchiectomy. In addition, normalized prostate specific antigen levels at 3 months from the start of therapy were predictive of good long-term outcome. Moreover, combined androgen blockade with nilutamide increased the chance of patients having normal prostate specific antigen levels at 3 months. Nilutamide was well tolerated in the long term with no increase in the incidence of drug specific adverse events.

CONCLUSIONS:

With long-term followup of patients with advanced prostate cancer, the combination of nilutamide and orchiectomy has significant benefits in interval to progression and improved survival compared to orchiectomy and placebo.

PMID:
9186345
[Indexed for MEDLINE]
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