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Sandy Srinivas, MD
Sandy Srinivas, MD
Posted: Tuesday, April 2, 2024
Previously reported results of the randomized FORMULA-509 trial showed that in a cohort of patients with prostate cancer, adding abiraterone acetate plus prednisone and apalutamide to postprostatectomy treatment improved metastasis-free survival, compared with adding bicalutamide. Now, an analysis of health-related quality-of-life results has shown that the addition of abiraterone acetate plus prednisone and apalutamide vs bicalutamide causes no detectable variance in patient-reported hormonal function, fatigue, or mental status. Karen E. Hoffman, MD, MHSc, MPH, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported their findings at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract 260).
All patients in FORMULA-509 had a prostate-specific antigen level of more than 0.5 ng/mL after radical prostatectomy, and they received salvage radiation and 6 months of a GnRH agonist in addition to either abiraterone acetate plus prednisone and apalutamide (n = 173) or bicalutamide (n = 172). The investigators used three validated questionnaires—EPIC-26 for hormonal domain, PROMIS Fatigue for fatigue, and SLUMS (Saint Louis University Mental Status Exam) for mental status; no differences emerged in patient-reported hormonal function, fatigue, or mental status between treatment arms either at the end of treatment or at 1 year after treatment.
Specifically, from baseline to the end of treatment, both arms demonstrated clinically meaningful declines in EPIC-26 for hormonal domain and increases in PROMIS Fatigue. Then, from the end of treatment to 1 year after treatment, patient-reported health-related quality of life improved to near baseline for both EPIC-26 for hormonal domain and fatigue.
Completion rates at baseline, the end of treatment, and at 1 year were 96%, 80%, and 70%, respectively, for EPIC-26 for hormonal domain; 95%, 79%, and 67% for PROMIS Fatigue; and 96%, 80%, and 70% for SLUMS, noted Dr. Hoffman and co-investigators. All median SLUMS scores were within the normal range at baseline, at the end of treatment, and at 1 year after treatment.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
2024 ASCO Genitourinary Cancers Symposium
