The researchers assessed the efficacy and safety of enzalutamide combined with androgen deprivation therapy leuprolide and compared the two as monotherapy in patients at high risk of biochemical recurrence of prostate cancer. Enzalutamide has been demonstrated to be superior in improving progression-free survival and without negatively affecting quality of life.
Researchers from universities and cancer centers in Canada, the United States, Brazil, South Korea, Australia and five European countries compared two methods to reduce the risk of prostate cancer metastasis in patients at high risk of biochemically confirmed recurrence. The study results were published in The New England Journal of Medicine.
|Five years of data from 1,068 men with prostate cancer were analyzed. All participants had a high risk of biochemical recurrence of the disease with time of a twofold increase in prostate-specific antigen levels <9 months. Patients were almost equally divided into three groups: combination therapy (enzalutamide 160 mg daily in combination with leuprolide every 12 weeks), androgen deprivation therapy with placebo (ADP monotherapy), and enzalutamide monotherapy. Metastasis-free survival rates were compared, as were patient-reported outcomes and adverse event rates.
At five years, metastasis-free survival was 87.3% in the combination therapy group, 71.4% in the ADP monotherapy group, and 80.0% in the enzalutamide monotherapy group. In the first group, the risk of metastases decreased by 58% compared to the ADP monotherapy group. Moreover, enzalutamide monotherapy was also superior to ADP monotherapy: the risk of disease progression decreased by 37%.
The authors identified no new adverse events with enzalutamide. Moreover, there were no differences between groups in patients’ quality of life.
In conclusion, an increase in metastasis-free survival has been demonstrated among patients with prostate cancer at high risk of biochemical relapse when treated with enzalutamide in combination with androgen deprivation therapy leuprolide, as well as with enzalutamide monotherapy. The safety profile of combination treatment and enzalutamide monotherapy remained acceptable, without deterioration in quality of life.