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Published on: May 11, 2016
Nilutamide as second line hormone therapy for prostate cancer after androgen ablation fails
Wassim Kassouf1, Simon Tanguay, Armen G Aprikian
1Montreal General Hospital and McGill University, Montreal, Quebec, Canada.
Purpose:
We investigate the prostate specific antigen (PSA) response rate with nilutamide as a second line hormonal agent in patients with advanced prostate cancer in whom androgen ablation failed.
Materials And Methods:
From 1998 to 2001, 28 patients with hormone resistant prostate cancer were treated with nilutamide as second line hormonal therapy. Average patient age +/- SD was 72.9 +/- 9.1 years. Median time from diagnosis of cancer to hormone failure was 48 months (range 2 to 120). Median followup from initiation of nilutamide therapy was 26 months (range 15 to 44). All patients had previously received at least 1 antiandrogen (flutamide or bicalutamide) in addition to medical or surgical castration, which failed.
Results:
Upon initiation of nilutamide therapy 18 of the 28 patients (64%) had an initial reduction in PSA and 8 (29%) sustained a PSA response (greater than 50% decrease) beyond 3 months (range 3 to 21). PSA response to nilutamide in patients with a previous antiandrogen withdrawal response versus nonresponse was 100% and 18%, respectively. In 10 of the 28 patients, (36%) PSA continued to increase. Interstitial pneumonitis developed, in 1 patient and 5 had nonspecific complaints (headaches, nausea, dizziness). During followup 6 of the 28 patients died 1 of whom was a nilutamide responder. No patient died while on nilutamide.
Conclusions:
Nilutamide can achieve a significant sustained PSA response with a favorable toxicity profile. Patients with a previous antiandrogen withdrawal response have a significantly greater chance of responding to nilutamide.
Insights
Nilutamide shows a significant prostate-specific antigen (PSA) response in advanced prostate cancer patients after hormone therapy failure. Prior anti-androgen withdrawal response predicts better outcomes with nilutamide.
Area of Science:
- Oncology
- Urology
Background:
- Advanced prostate cancer often becomes resistant to initial hormonal therapies.
- Hormone-refractory prostate cancer necessitates exploring alternative treatment strategies.
- Prostate-specific antigen (PSA) is a key biomarker for monitoring treatment response in prostate cancer.
Purpose of the Study:
- To evaluate the PSA response rate of nilutamide as a second-line hormonal agent.
- To assess nilutamide's efficacy in patients with advanced prostate cancer who failed prior androgen ablation.
- To determine the safety and tolerability of nilutamide in this patient population.
Main Methods:
- A cohort of 28 patients with hormone-resistant prostate cancer received nilutamide as second-line therapy.
- Patients had previously undergone anti-androgen treatment (flutamide or bicalutamide) and castration, which failed.
- Median follow-up was 26 months, with PSA levels monitored throughout the study period.
Main Results:
- 64% of patients experienced an initial PSA reduction with nilutamide.
- 29% achieved a sustained PSA response (over 50% decrease) lasting beyond 3 months.
- Patients with a prior anti-androgen withdrawal response showed a 100% PSA response rate compared to 18% for non-responders.
Conclusions:
- Nilutamide demonstrates a significant and sustained PSA response in advanced prostate cancer.
- The drug exhibits a favorable toxicity profile, with manageable side effects.
- A history of anti-androgen withdrawal response is a strong predictor of successful nilutamide treatment.

