Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis.

Abstract

Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy. The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175-0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov).

• Authors: Joan Carles, Rafael A Medina-Lopez, Javier Puente, Álvaro Gómez-Ferrer, Javier Casas Nebra, María Isabel Sáez Medina, Maria J Ribal, Alfredo Rodríguez Antolín, José Luís Álvarez-Ossorio, José Francisco Suárez Novo, Cristina Moretones Agut, Shankar Srinivasan, Jorge Ortiz, Karim Fizazi
• Journal: Future oncology (London, England) (Future Oncol) Vol. 19 Issue 12 Pg. 819-828 (Apr 2023) ISSN: 1744-8301 [Electronic] England
• PMID: 37222151 (Publication Type: Randomized Controlled Trial, Journal Article)

Chemical References

• Androgen Receptor Antagonists
• darolutamide
• Androgen Antagonists
• Pyrazoles

Topics

• Male
• Humans
• Prostatic Neoplasms, Castration-Resistant (pathology)
• Androgen Receptor Antagonists (adverse effects)
• Androgen Antagonists (adverse effects)
• Pyrazoles (adverse effects)