Does Apalutamide Negatively Impact Quality of Life in Nonmetastatic CRPC?
Posted: Tuesday, January 15, 2019
According to an exploratory analysis of the SPARTAN trial, the addition of apalutamide to androgen-deprivation therapy does not seem to worsen health-related quality of life for men with castration-resistant prostate cancer (CRPC). Although the androgen receptor inhibitor approved by the U.S. Food and Drug Administration has shown efficacy in prolonging metastasis-free and symptomatic progression-free survival in this patient population, data regarding quality of life had been lacking. The results of this study, by Fred Saad, MD, of the University of Montreal Hospital Center, and colleagues, were published in The Lancet Oncology.
“The fact that a novel, efficacious treatment can be added to current standard of care while maintaining patient [health-related quality of life] is a substantial advance for patients with nonmetastatic castration-resistant prostate cancer and the clinicians who treat them,” concluded the study investigators.
In this multicenter, international, randomized, phase III trial, 1,207 patients with asymptomatic, high-risk, nonmetastatic, castration-resistant prostate cancer were assigned to receive apalutamide with androgen-deprivation therapy (n = 806) or placebo with androgen-deprivation therapy (n = 401). Health-related quality of life was assessed using the Functional Assessment of Cancer Therapy–Prostate and EuroQol five-dimension, three-level questionnaires.
After a median follow-up of 20.3 months, the group mean patient-reported health-related quality-of-life scores remained mostly consistent in both groups. It is important to note that a decline in scores was not seen in the group receiving apalutamide; in fact, least-squares mean change from baseline showed a slight decrease in the placebo group.
According to Dr. Saad, these results bode “great news for patients”. Others noted the aggregate nature of these findings, and that likely, individual patient experiences reflect a wider range of outcomes.
Disclosure: The study authors’ disclosure information may be found at thelancet.com.