EMBARK: HRQoL in nmHSPC Patients With High-Risk BCR

A presentation given at the European Society for Medical Oncology Congress 2023 provided new understandings of patient-reported outcomes (PROs) related to enzalutamide-plus-leuprolide-acetate treatment for high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC).

Previous reports on the phase 3 EMBARK study highlighted the positive effects of enzalutamide plus leuprolide acetate, as well as enzalutamide alone, in patients with high-risk BCR nmHSPC. In the study, patients with nmHSPC and high-risk BCR were randomized (1:1:1) to receive enzalutamide plus leuprolide acetate, enzalutamide alone, or placebo plus leuprolide acetate.

Stephen J. Freedland, MD, of Cedars-Sinai Medical Center, and colleagues assessed PROs at baseline and every 12 weeks until disease metastasis or death.

The main objectives were to assess therapy effects in time to first deterioration (TTFD) and time to first confirmed clinically meaningful deterioration (TTFCD), as measured with the Brief Pain Inventory-Short Form (BPI-SF) worst pain and Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score using predefined thresholds. Other objectives included therapy effects in TTFD and TTFCD measured by the European Organization for Research, as well as the Therapy of Cancer QoL Questionnaire-Prostate 25 (QLQ-PR25) and EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L) visual analogue scale (VAS).

At baseline, researchers reported between 327 and 332 patients in each treatment cohort completed the PRO questionnaire. No significant differences in TTFD or TTFCD were seen among patients in the investigative arms versus placebo plus leuprolide acetate in FACT-P total score, BPI-SF worst pain, or EQ-5D-5L VAS.

In QLQ-PR25, TTFCD for sexual activity was significantly longer with enzalutamide alone versus placebo plus leuprolide acetate. Additionally, TTFCD for hormone therapy-related symptoms was found to be significantly shorter with enzalutamide plus leuprolide acetate versus placebo plus leuprolide acetate.

“Enzalutamide plus leuprolide acetate or enzalutamide alone improves metastasis-free survival without negatively impacting global health-related quality of life or clinical pain progression versus placebo plus leuprolide acetate in nmHSPC patients,” Dr. Freedland and colleagues concluded. “Sexual activity may be better preserved with enzalutamide alone versus placebo plus leuprolide acetate.”