Enzalutamide/ADT in Metastatic Hormone-Sensitive Prostate Cancer: ARCHES Trial
Posted: Monday, September 16, 2019
According to results from the phase III ARCHES trial, published in the Journal of Clinical Oncology, men with metastatic hormone-sensitive prostate cancer experienced significant survival benefits after undergoing treatment with the androgen receptor inhibitor enzalutamide plus androgen-deprivation therapy (ADT). The safety analysis showed a consistent safety profile with enzalutamide from previous trials in castration-resistant disease.
“Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer, including those with low-volume disease and/or prior docetaxel,” concluded Andrew J. Armstrong, MD, ScM, of the Duke Cancer Institute, Durham, North Carolina, and colleagues.
The study included 1,150 men with metastatic hormone-sensitive prostate cancer. Participants were assigned to receive either 160 mg daily of enzalutamide plus ADT or placebo plus ADT. Patients receiving enzalutamide and ADT experienced a markedly lower risk of radiographic disease progression or death than those receiving placebo (hazard ratio = 0.39; 95% confidence interval = 0.30–0.50; P < .001; median not reached vs. 19 months). Other benefits experienced by the enzalutamide group included a reduced risk of “prostate-specific antigen [PSA] progression, initiation of new antineoplastic therapy, first symptomatic skeletal event, castration resistance, and reduced risk of pain progression.” Overall, more men in the enzalutamide group achieved undetectable PSA levels, an objective response, or both than did men in the placebo group (P < .001).
Participants were stratified by history of docetaxel treatment as well as volume of disease present. Patients in these predetermined subgroups who received enzalutamide plus ADT were also found to experience notable radiographic progression-free survival benefits when compared with the placebo group.
The enzalutamide group also reported expected safety outcomes. A total of 24.3% of patients receiving enzalutamide plus ADT experienced an adverse event grade 3 or higher versus 25.6% of patients receiving placebo plus ADT.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.