The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups.

Enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival versus ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in ARCHES (NCT02677896). While health-related quality of life (HRQoL) was generally maintained in the intent-to-treat population, we further analyzed patient-reported outcomes (PROs) in defined subgroups.

ARCHES was a randomized, double-blind, placebo-controlled, phase 3 study. Patients with mHSPC received enzalutamide (160 mg/day) plus ADT (n = 574) or placebo plus ADT (n = 576). Questionnaires, including the Functional Assessment of Cancer Therapy-Prostate, Brief Pain Inventory-Short Form, and EuroQol 5-Dimension, 5-Level (EQ-5D-5L), were completed at baseline, Week 13, and every 12 weeks until disease progression. PRO endpoints were time to first confirmed clinically meaningful deterioration (TTFCD) in HRQoL or pain. Subgroups included prognostic risk, pain/HRQoL, prior docetaxel, and local therapy (radical prostatectomy [RP] and/or radiotherapy [RT]).

There were several between-treatment differences in TTFCD for pain and functioning/HRQoL PROs. Enzalutamide plus ADT delayed TTFCD for worst pain in the prior RT group (not reached vs. 14.06 months; hazard ratio [HR]: 0.56 [95% confidence interval: 0.34-0.94]) and pain interference in low-baseline-HRQoL group (19.32 vs. 11.20 months; HR: 0.64 [0.44-0.94]) versus placebo plus ADT. In prior/no prior RP, prior RT, prior local therapy, no prior docetaxel, mild baseline pain, and low-risk subgroups, TTFCD was delayed for the EQ-5D-5L visual analog scale.

Enzalutamide plus ADT provides clinical benefits in defined patient subgroups versus ADT alone, while maintaining lack of pain and high HRQoL, with delayed deterioration in several HRQoL measures.

The Prostate. 2022 Jun 08 [Epub ahead of print]

Arnulf Stenzl, Russell Z Szmulewitz, Daniel Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, Arun Azad, Antonio Alcaraz, Boris Alekseev, Taro Iguchi, Neal D Shore, Francisco Gomez-Veiga, Cristina Ivanescu, Brad Rosbrook, Krishnan Ramaswamy, Arijit Ganguli, Gabriel P Haas, Andrew J Armstrong

Department of Urology, University Hospital, Eberhard Karls University of Tübingen, Tübingen, Germany., Department of Medicine, The University of Chicago, Chicago, Illinois, USA., Department of Medical Oncology, Yale Cancer Center, New Haven, Connecticut, USA., Department of Urologic Oncology, The University of Kansas Medical Center, Kansas City, Kansas, USA., Department of Urology, Lille University, Lille, France., Department of Medicine, Monash Health, Melbourne, Victoria, Australia., Department of Urology, Hospital Clinic de Barcelona, Barcelona, Spain., Department of Oncology, Hertzen Moscow Cancer Research Institute, Moscow, Russia., Department of Urology, Kanazawa Medical University, Ishikawa, Japan., Department of Urology, Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA., Department of Urology, Salamanca University Hospital, Salamanca, Spain., Statistical Services and Patient Centered Solutions, IQVIA, Amsterdam-Zuidoost, the Netherlands., Department of Global Biometrics and Data Management, Pfizer Inc., San Diego, California, USA., Global HEOR, Pfizer Inc., New York, New York, USA., Global HEOR, Astellas Pharma Inc., Northbrook, Illinois, USA., Global Medical Affairs, Astellas Pharma Inc., Northbrook, Illinois, USA., Divisions of Medical Oncology and Urology, Duke Cancer Institute Center for Prostate & Urologic Cancers, Durham, North Carolina, USA.

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