ARAMIS QoL results add support for darolutamide in nonmetastatic CRPC
medwireNews: Men with nonmetastatic castration-resistant prostate cancer (CRPC) enrolled in the ARAMIS trial report favorable quality of life (QoL) outcomes with darolutamide relative to placebo.
Speaking at the 2019 ASCO Annual Meeting in Chicago, Illinois, USA, study author Karim Fizazi (Institut Gustave Roussy, Villejuif, France) said that these data together with the previously reported efficacy results suggest that darolutamide may be “an attractive treatment option” for nonmetastatic CRPC.
The risk for pain progression was a significant 35% lower for the 955 participants who were randomly assigned to receive darolutamide 1200 mg alongside androgen deprivation therapy (ADT) than for their 554 counterparts who instead received placebo plus ADT. The median time to pain progression was 40.3 and 25.4 months, respectively.
Similarly, darolutamide-treated patients had a significant 57% reduction in the risk for symptomatic skeletal events relative to those given placebo, although the median time to first symptomatic skeletal event was unreached in both groups at the time of analysis.
Mean scores on the prostate cancer subscale of the Functional Assessment of Cancer Therapy–Prostate QoL questionnaire remained comparable between the darolutamide and placebo arms throughout the treatment and follow-up periods, and the time to deterioration of QoL was significantly longer with darolutamide than placebo, at a median of 11.1 versus 7.9 months.
Fizazi reported that darolutamide led to “clinically significant delays” in the time to deterioration of bowel and urinary symptoms, as assessed by the EORTC QLQ-PR25 questionnaire, compared with placebo. But he pointed out that the time to deterioration for other symptom subscales – such as incontinence and sexual functioning – did not vary significantly between the groups.
Noting that the trial has now demonstrated “improvements in both quality and quantity of life measures,” discussant Daniel Spratt, from the University of Michigan in Ann Arbor, USA, concluded that these findings put darolutamide “amongst the armamentarium of treatments for nonmetastatic CRPC, alongside apalutamide and enzalutamide.”
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