Enzalutamide improved results in patients with biochemically recurrent prostate cancer
This study focused on men with prostate cancer who were at high risk for recurrence. Specifically, the
researchers were interested in patients whose prostate-specific antigen (PSA) levels were rising quickly. When PSA levels double quickly, there is a higher risk that the cancer will spread or get worse. The study aimed to compare how well different treatments worked in keeping the cancer from spreading and how safe those treatments were.
The treatments tested were:
1. Combination therapy: enzalutamide (a drug that blocks male hormones that help cancer grow) plus leuprolide (a hormone therapy that reduces testosterone levels).
2. Leuprolide alone: this is a standard treatment that lowers testosterone, which fuels the growth of prostate cancer.
3. Enzalutamide alone: this option tests enzalutamide as a stand-alone treatment without leuprolide.
A total of 1,068 men participated in the study, and were divided into three groups. One group received the combination of enzalutamide and leuprolide, another received only leuprolide, and the third took only enzalutamide. The primary goal was to see how long it took before the cancer spread (metastasis-free survival). The patients were followed for a median of about 5 years (60.7 months).
The key findings were:
• At the end of the study, 87.3% of the patients who received the combination of enzalutamide and leuprolide had no evidence of cancer progression after 5 years.
• In comparison, only
71.4% of the patients who received leuprolide alone remained metastasis-free.
• The enzalutamide-only group also did better than the leuprolide-only group, with 80.0% of those patients having no signs of cancer spread after 5 years.
The results showed that both the combination treatment and enzalutamide alone were significantly better at preventing the cancer from spreading than leuprolide alone. In terms of numbers, the combination therapy reduced the risk of metastasis or death by 58%, and enzalutamide alone reduced this risk by 37%, compared to leuprolide alone.
Safety and quality of life:
The study also examined the safety of these treatments and whether they affected the patient’s quality of life. No new safety concerns were found, meaning the treatments did not have unexpected side effects. There were no major differences in the quality of life reported by the patients in the different groups.
The authors concluded that adding enzalutamide to leuprolide or using enzalutamide alone were both more effective than using leuprolide alone for treating men with high-risk prostate cancer. Both treatments significantly reduced the chance of the cancer spreading over 5 years without causing any new safety issues or negatively affecting patients’ quality of life.
N Engl J Med 2023;389:1453-1465.DOI: 10.1056/NEJMoa2303974
