ARCHES Patient-Reported Outcomes Published
A multi-institutional group of clinical researchers, including Duke Cancer Institute’s Andrew Armstrong, MD, MSc, FACP, published a new report this month in the European Urology journal that describes results of patient-reported outcomes (PROs) on the ARCHES study.
Previously published in the Journal of Clinical Oncology (JCO), ARCHES prospectively studied and evaluated the efficacy and safety of enzalutamide, an androgen-receptor inhibitor, in conjunction with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC), as compared to standard ADT alone.
“In December 2019, the U.S. FDA approved enzalutamide for the treatment of men with metastatic prostate cancer that is considered hormonally sensitive (mHSPC) based on the phase 3 global ARCHES trial,” said Armstrong. “The original study, along with the phase 3 ENZAMET trial, demonstrated that enzalutamide with ADT can significantly delay the time that men have until they develop radiographic progression or death, and this is accompanied by significant improvements in PSA levels, tumor seen on imaging, substantial delays in pain deterioration, and need for further therapy.”
The new study, an analysis of the ARCHES randomized, placebo-controlled, phase 3 study, evaluated the effect of Enzalutamide plus ADT on health-related quality of life in patients with mHSPC. Results confirmed Enzalutamide plus ADT enables men with mHSPC to maintain high functioning health-related quality of life (HRQoL) and low symptom burden.
“In this current secondary analysis, we further explored the impact of this more intensive hormonal regimen on daily patient-reported outcomes and quality of life. We found that the vast majority of men are able to maintain a high level of quality of life in all domains, including physical, emotional, social, and global aspects,” explained Armstrong. “As compared to placebo, enzalutamide delayed pain deterioration, especially in men with a high burden of disease. The quality of life analyses differed according to this burden of disease, and certain metrics were worse with enzalutamide, including hormonal and sexual quality of life. However, overall these results indicate that the improved survival and outcomes seen with enzalutamide in this setting do not require that men sacrifice overall quality of life.”
The research team, co-led by Arnulf Stenzl, MD, University of Tübingen, Germany and Andrew Armstrong, professor of Medicine at Duke Cancer Institute, measured PROs at baseline, week 13, and every 12 weeks until disease progression using the European Organization 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. Study end points included time to first (TTFD) and first confirmed (TTFCD) clinically meaningful deterioration in HRQoL and pain.