ASCO 2019: Quality-of-Life Outcomes With Darolutamide in Prostate Cancer
Posted: Thursday, June 13, 2019
The ARAMIS study suggests that androgen receptor antagonist darolutamide prolongs metastasis-free survival, maintains patients’ quality of life, and delays disease-related symptoms for patients with nonmetastatic castrate-resistant prostate cancer. In fact, the findings were “clearly positive” with darolutamide in this patient population, according to Karim Fizazi, MD, PhD, of the Institute Gustave Roussy, University of Paris-Sud, France, with a 59% reduction in the risk of metastasis or death. The results of this phase III study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 5000).
A total of 1,509 patients with nonmetastatic castrate-resistant prostate cancer were randomly assigned to receive either darolutamide (600 mg twice daily) or placebo with androgen-deprivation therapy. Quality of life was assessed every 16 weeks until the end of treatment through the use of the European Organisation for Research and Treatment of Cancer Quality-of-Life Prostate Cancer module.
Metastasis-free survival was improved in the darolutamide arm of the study compared with placebo (40.4 months vs. 18.4 months). Interim overall survival also favored darolutamide (hazard ratio = 0.71). Darolutamide was also able to delay progression of pain compared with placebo (40.3 months vs. 25.4 months), which was maintained beyond the end of study treatment. Furthermore, patients treated with darolutamide saw statistically and clinically significant delays in quality-of-life deterioration in relation to urinary symptoms (25.8 months vs. 14.8 months).
Overall, darolutamide reported to be well tolerated by patients. The exposure-adjusted incidence of adverse events was similar or lower with darolutamide compared with placebo. Adverse events recorded with the use of darolutamide included fatigue/asthenic conditions (11.3 vs. 11.1), hypertension (4.7 vs. 5.1), hot flush (3.7 vs. 4.1), fracture (3.0 vs.. 3.5), falls (2.7 vs. 4.1), cognitive disorder (0.3 vs. 0.2), and seizure (0.2 vs. 0.2).
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
