ARAMIS Trial in Prostate Cancer: Impact of Darolutamide on Pain and Quality of Life - Karim Fizazi

Karim Fizazi and Alicia Morgans discuss a follow-up on the quality of life parameters evaluated in the ARAMIS trial. Darolutamide was also associated with benefits with regard to all secondary end points, including overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal-related event. The incidence of adverse events that occurred or worsened during the treatment period and had a frequency of 5% or more or were of grade 3 or higher was similar in the two groups; all such events except fatigue occurred in less than 10% of patients in either group. The percentage of patients who discontinued the assigned regimen because of adverse events was 8.9% in the darolutamide group and 8.7% in the placebo group. Darolutamide was not associated with a higher incidence of seizures, falls, fractures, cognitive disorder, or hypertension than placebo. Dr. Fizazi also elaborates on patient-reported quality of life which was similar in the darolutamide group and placebo group. Differences in least-squares mean time-adjusted AUC scores consistently favored darolutamide and were significant for BPI-SF (pain severity and pain interference scores), FACT-P (Physical Well-Being, Emotional Well-Being, PCS, General, FACT-P total, and Trial Outcome Index), and the EORTC-QLQ-PR25 urinary symptoms subscale.


Karim Fizazi, MD, Ph.D. Dr. Karim Fizazi is Professor of Medicine of Institut Gustave Roussy, (IGR) in Villejuif, France.

Alicia Morgans, MD, MPH, is an Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

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