Darolutamide in Treatment of Nonmetastatic Prostate Cancer: Outcomes Update From ARAMIS
The 3-year overall survival was better with darolutamide than with a placebo for men with nonmetastatic castration-resistant prostate cancer, according to a recent final analysis from the phase III ARAMIS trial. Matthew R. Smith, MD, PhD, of Massachusetts General Hospital in Boston, and colleagues published their findings in The New England Journal of Medicine.
“Darolutamide was also associated with a significant benefit with respect to all other secondary endpoints, including the time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy,” the authors wrote.
The double-blind trial included 1,509 men with nonmetastatic castration-resistant prostate cancer with a prostate-specific antigen (PSA) doubling time of up to 10 months. Patients were randomly assigned in a 2:1 ratio to receive darolutamide (955 patients) or placebo (554 patients) and continued to receive androgen-deprivation therapy. At this time, all 170 patients who were receiving the placebo elected to switch to darolutamide, and 137 patients who had already left the placebo arm were receiving some type of life-prolonging therapy (most commonly docetaxel, abiraterone acetate, or enzalutamide). Data for the current analyses were collected until November 15, 2019. The median follow-up time was 29 months.
Overall survival at 3 years was significantly higher with darolutamide (83%) than with the placebo (77%). Median metastasis-free survival was also significantly longer with darolutamide (40.4 months vs. 18.4 months). Secondary endpoints—time to first symptomatic skeletal event, time to first use of cytotoxic chemotherapy, and time to pain progression—were improved with darolutamide compared with the placebo.
The frequency of adverse events was similar in the two treatment groups. The authors pointed out that the small number of patients of African descent enrolled (52 of 1,509) is a limitation of the study.
Disclosure: The study authors’ disclosure information may be found at www.nejm.org.