Adding enzalutamide to androgen deprivation therapy enables men with metastatic hormone-sensitive prostate cancer (mHSPC) to maintain high-functioning health-related quality of life (HRQoL), according to investigators.
The finding is from the ARCHES study, a randomized phase 3 trial in which 1150 men with mHSPC received either enzalutamide (160 mg/day) or placebo in addition to ADT. The trial previously had demonstrated enzalutamide-treated patients had improved radiographic progression-free survival (rPFS) compared with those receiving ADT alone.
“Prolongation of rPFS with enzalutamide plus ADT is accompanied by maintenance of HRQoL. Thus, enzalutamide represents a treatment strategy for mHSPC that provides clinical benefits while maintaining HRQoL, Arnulf Stenzl, MD, of University Hospital, Eberhard Karls University of Tübingen, Tübingen, Germany, and colleagues concluded in an online report in European Urology.
Dr Stenzl’s team measured patient-reported outcomes (PROs) at baseline, week 13, and every 12 weeks until disease progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate 25 (QLA-PR25), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Brief Pain Inventory Short Form, and EuroQol 5-Dimensions, 5-Levels (EQ-FD-5 L) instruments. The end points included time to first (TTFD) and first confirmed (TTFCD) clinically meaningful deterioration in health-related quality of life (HRQoL) and pain.
PRO scores at baseline indicated high HRQoL and low pain, and these were generally maintain in both groups, Dr Stenzl’s team reported. The investigators found no significant difference between study arms with regard to both TTFD and TTFCD together for QLA-PR25 and FACT-P scores. In addition, enzalutamide significantly delayed TTFD in worse pain (by approximately 3 months), pain severity, and EQ-5D5 L visual analogue scale score compared with placebo.
Stenzl A, Dunshee C, De Giorgi U, et al. Effect of enzalutamide plus androgen deprivation therapy on health-related quality of life in patients with metastatic hormone-sensitive prostate cancer: An analysis of the ARCHES randomised, placebo-controlled, phase 3 study [published online April 23, 2020]. Eur Urol. doi: 10.1016/j.eururo.2020.03.019