Patient-reported health-related quality of life (HRQoL) in the randomized FORMULA-509 trial of salvage radiotherapy and 6 months of GnRH agonist with either bicalutamide or abiraterone acetate plus prednisone (AAP) and apalutamide (Apa) after radical prostatectomy (RP).
Authors: Karen E. Hoffman, Paul L. Nguyen, Dana E. Rathkopf, Amado J. Zurita, Daniel Eidelberg Spratt, Robert Timothy Dess, Stanley L. Liauw, Russell Zelig Szmulewitz, David Johnson Einstein, Glenn Bubley, James B. Yu, Yi An, Anthony C. Wong, Felix Y Feng, Rana R. McKay, Brent S. Rose, Kee-Young Shin, Adam S. Kibel, Mary-Ellen Taplin, Marisa Kollmeier
Journal: Journal of Clinical Oncology (2024)

260 Background: The randomized FORMULA-509 trial demonstrated that for patients with a PSA &gt;0.5 after RP receiving salvage radiation and 6 months of GnRH Agonist, the addition of AAP and Apa improved metastasis-free survival compared to bicalutamide. Here we present the patient-reported health-related quality of life (HRQoL) results. Methods: Validated questionnaires were administered at baseline, end of treatment, and 1 year after completion of treatment. Patients completed EPIC-26, PROMIS Fatigue, and Saint Louis University Mental Status Exam (SLUMS). EPIC-26 is scored from 0 to 100 with 100 indicating higher function. PROMIS Fatigue is scored using a standardized T score with higher score indicating greater fatigue. SLUMS is scored from 0 to 30 with 27 to 30 interpreted as normal, 21 to 26 as mild neurocognitive disorder and 20 or less as dementia. Scores between treatment arms were compared using the t-test. Results were interpreted using established thresholds for clinically meaningful differences (4-6 for EPIC-26 hormonal domain, 5-10 for PROMIS Fatigue). Results: 345 patients were randomized (172 bicalutamide; 173 AAP/Apa). Completion rates at baseline, end of treatment, and 1 year, were 96%, 80%, and 70% for EPIC-26, 95%, 79%, and 67% for PROMIS Fatigue, and 96%, 80%, and 70% for SLUMS. From baseline to end of treatment, both arms demonstrated clinically meaningful declines in EPIC-26 hormonal domain (median change -15 bicalutamide; -15 AAP/Apa) and increase in PROMIS Fatigue (median change 6 bicalutamide; 7.4 AAP/Apa). From end of treatment to 1 year after treatment patient-reported HRQoL improved to near baseline for both EPIC-26 hormonal function (bicalutamide median score baseline: 95, end: 75, 1 year: 90; AAP/Apa baseline: 95, end: 75, 1 year: 90) and fatigue (bicalutamide median score baseline: 43.1, end: 48.6, 1 year: 46.0; AAP/Apa baseline: 43.1, end: 51.0, 1 year: 46.0). Median SLUMS score was within normal range at baseline (27 bicalutamide; 27 AAP/Apa), end of treatment (28, 28) and 1 year after treatment (27, 27). There was no difference in patient-reported hormonal function, fatigue, or mental status between treatment arms, at end of treatment (p=0.40; 0.78; 0.41 respectively) and 1 year after treatment (p=0.78; 0.89; 0.76 respectively). Conclusions: The addition of AAP/Apa improved oncologic outcomes without causing a detectable difference in patient-reported hormonal function, fatigue, or mental status compared to bicalutamide. Clinical trial information: NCT03141671 .