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Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.
- Source :
- Oncologist; Mar2024, Vol. 29 Issue 3, p235-243, 9p
- Publication Year :
- 2024
-
Abstract
- Background In the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS. Patients and Methods Patients with mHSPC were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety. Results In ARASENS, 54 Black patients received darolutamide (n = 26) or placebo (n = 28) plus ADT and docetaxel. In Black patients, overall survival favored darolutamide versus placebo (median, not reached vs. 38.7 months; stratified HR, 0.41; 95% CI, 0.17-1.02), with 4-year survival rates of 62% versus 41%. The darolutamide group also had longer time to CRPC compared with the placebo group (median, not reached vs.12.6 months; HR, 0.09; 95% CI, 0.02-0.30). The safety profile of darolutamide in Black patients was consistent with that observed for the overall ARASENS population (grade 3/4 treatment-emergent adverse events, TEAEs: 61.5% vs. 66.1%; serious TEAEs: 42.3% vs. 44.8%). Conclusion In this small population of Black patients with mHSPC from the ARASENS trial, darolutamide was associated with an improvement in survival and time to CRPC and was well tolerated. Efficacy and safety findings in Black patients were consistent with the overall ARASENS population. [ABSTRACT FROM AUTHOR]
- Subjects :
- THERAPEUTIC use of antineoplastic agents
DRUG efficacy
COMBINATION drug therapy
HORMONE therapy
ANTIANDROGENS
CONFIDENCE intervals
METASTASIS
PLACEBOS
RANDOMIZED controlled trials
CASTRATION-resistant prostate cancer
SURVIVAL rate
COMPARATIVE studies
DOCETAXEL
RESEARCH funding
DESCRIPTIVE statistics
ODDS ratio
STATISTICAL sampling
PATIENT safety
AFRICAN Americans
PROSTATE tumors
OVERALL survival
Subjects
Details
- Language :
- English
- ISSN :
- 10837159
- Volume :
- 29
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 175824229
- Full Text :
- https://doi.org/10.1093/oncolo/oyad254