@misc{10498/31131,
year = {2023},
month = {5},
url = {http://hdl.handle.net/10498/31131},
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.},
publisher = {Newlands Press},
keywords = {androgen receptor inhibitor},
keywords = {castration-resistant prostate cancer},
keywords = {darolutamide},
keywords = {metastasis-free survival},
keywords = {nonmetastatic},
keywords = {prostate-specific antigen},
keywords = {PSA progression},
keywords = {Spain},
keywords = {Spanish},
title = {Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis},
doi = {10.2217/fon-2022-1131},
author = {Carles, Joan and Medina Lopez, Rafael A. and Puente, Javier and Gómez Ferrer, Álvaro and Casas Nebra, Javier and Sáez Medina, María Isabel and Ribal, Maria J. and Rodríguez Antolín, Alfredo and Álvarez-Ossorio Fernández, José Luis and Suárez Novo, José Francisco and Moretones Agut, Cristina and Srinivasan, Shankar and Ortiz, Jorge and Fizazi, Karim},
}