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The New England Journal of MedicineImproved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer

Enzalutamide Shows Superiority in Metastasis-Free Survival for Prostate Cancer Patients

A recent phase 3 trial has shed new light on the treatment of patients with prostate cancer who have high-risk biochemical recurrence. The study compared the efficacy and safety of enzalutamide plus androgen-deprivation therapy and enzalutamide monotherapy with androgen-deprivation therapy alone.

HCN Medical Memo
The findings from this study could have significant implications for healthcare professionals treating patients with prostate cancer. The superior metastasis-free survival rates observed with enzalutamide plus leuprolide and enzalutamide monotherapy could lead to a paradigm shift in the treatment of patients with high-risk biochemical recurrence. This could potentially impact patient care by providing more effective treatment options.

Study Design

  • The study enrolled patients with prostate cancer who had high-risk biochemical recurrence with a prostate-specific antigen doubling time of 9 months or less.
  • A total of 1,068 patients underwent randomization.
  • Patients were randomly assigned to receive enzalutamide (160 mg) daily plus leuprolide every 12 weeks (combination group), placebo plus leuprolide (leuprolide-alone group), or enzalutamide monotherapy (monotherapy group).
  • The primary end point was metastasis-free survival, as assessed by blinded independent central review.

According to the American Cancer Society, prostate cancer is the second most common cancer among men in the United States.

Key Findings:

  • At 5 years, metastasis-free survival was 87.3% in the combination group, 71.4% in the leuprolide-alone group, and 80.0% in the monotherapy group.
  • Enzalutamide plus leuprolide was superior to leuprolide alone; enzalutamide monotherapy was also superior to leuprolide alone.
  • No new safety signals were observed, with no substantial between-group differences in quality-of-life measures.

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