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Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind
R A Janknegt1, C C Abbou, R Bartoletti
1Department of Urology, University Hospital Maastricht, The Netherlands.
Abstract:
The efficacy and tolerance of the nonsteroidal antiandrogen nilutamide in the treatment of prostatic cancer were studied in a large double-blind clinical trial initiated in 1986. Patients with metastatic prostatic cancer without prior endocrine manipulation underwent orchiectomy and were randomized to 1 of 2 groups receiving nilutamide (225 patients) or placebo (232). Nilutamide and placebo were evaluated for efficacy in 207 and 216 patients, respectively. Progression-free survival was significantly longer in the nilutamide group (median time to progression 20.8 months on nilutamide and 14.9 months on placebo, p = 0.005). Median time to death from prostatic cancer was 30.0 months in the placebo group and 37 months in the nilutamide group. Objective regressions were higher in the nilutamide group (41%) than in the placebo group (24%). Significant differences in favor of the nilutamide group were found at several intervals for bone pain, prostatic acid phosphatase, prostate specific antigen, alkaline phosphatase and bone scan isotope uptake. Nilutamide and orchiectomy constitute a more effective treatment for metastatic prostatic cancer than orchiectomy alone, and the adverse effects of nilutamide, usually minor, are outweighed by the significant improvements in most disease measures and progression-free survival.
Insights
Nilutamide combined with orchiectomy significantly improves progression-free survival and objective regressions in metastatic prostate cancer patients. This combination therapy offers greater efficacy than orchiectomy alone, with manageable side effects.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic prostate cancer requires effective endocrine manipulation.
- Orchiectomy is a standard treatment, but improved therapies are needed.
Purpose of the Study:
- To evaluate the efficacy and tolerance of nilutamide plus orchiectomy versus placebo plus orchiectomy in metastatic prostate cancer.
Main Methods:
- A large, double-blind, randomized clinical trial.
- Patients received either nilutamide or placebo alongside orchiectomy.
- Efficacy and survival endpoints were assessed.
Main Results:
- Nilutamide significantly increased progression-free survival (20.8 vs. 14.9 months, p=0.005).
- Higher objective regression rates (41% vs. 24%) and improved survival (37 vs. 30 months) were observed with nilutamide.
- Favorable differences were noted for bone pain, PSA, and bone scans.
Conclusions:
- Nilutamide combined with orchiectomy is more effective than orchiectomy alone for metastatic prostate cancer.
- Adverse effects of nilutamide were generally minor and outweighed by clinical benefits.
- This combination therapy represents an improved treatment option.