Posted: Thursday, November 16, 2023
In patients with prostate cancer who have high-risk biochemical recurrence, the androgen receptor blocker enzalutamide plus leuprolide was found to be superior to leuprolide alone with respect to metastasis-free survival, according to a recent phase III trial published in The New England Journal of Medicine. According to study author Stephen J. Freedland, MD, of Cedars-Sinai, Los Angeles, enzalutamide monotherapy was also found to be superior to leuprolide alone. Data on overall survival were immature at the time of publication.
“In the study, both of these new options improved metastasis-free survival while preserving quality of life,” commented Dr. Freedland in a Cedars-Sinai press release. “If these treatments are approved by the FDA, the results will be practice-changing.”
From January 2015 to August 2018, a total of 1,068 patients took part in this trial; they were from 244 sites in 17 countries. The majority of patients (83.2%) were White, and the median patient age was 69. A total of 355 patients were assigned to the combination group (enzalutamide plus leuprolide); 358, to the leuprolide-alone group; and 355, to enzalutamide monotherapy group. The patients were followed for a median of 60.7 months.
At 5 years, metastasis-free survival rate was 87.3% in the combination group (95% confidence interval [CI] = 83.0%–90.6%), 71.4% in the leuprolide-alone group (95% CI = 65.7%–76.3%), and 80.0% in the enzalutamide monotherapy group (95% CI = 75.0%–84.1%). In addition, in terms of metastasis-free survival, both enzalutamide plus leuprolide (hazard ratio for metastasis and death = 0.42) and enzalutamide monotherapy (hazard ratio for metastasis or death = 0.63) were reported to be superior to leuprolide alone. Of note, no new safety signals were observed, with no substantial between-group differences in quality-of-life measures reported.
Disclosure: The study was sponsored by Pfizer and Astellas Pharma. Dr. Freedland has served as a consultant to Astellas Pharma. For full disclosures of the other study authors, visit nejm.org.