RT journal article
T1 Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis
A1 Carles, Joan
A1 Medina Lopez, Rafael A.
A1 Puente, Javier
A1 Gómez Ferrer, Álvaro
A1 Casas Nebra, Javier
A1 Sáez Medina, María Isabel
A1 Ribal, Maria J.
A1 Rodríguez Antolín, Alfredo
A1 Álvarez-Ossorio Fernández, José Luis
A1 Suárez Novo, José Francisco
A1 Moretones Agut, Cristina
A1 Srinivasan, Shankar
A1 Ortiz, Jorge
A1 Fizazi, Karim
A2 Cirugía
K1 androgen receptor inhibitor
K1 castration-resistant prostate cancer
K1 darolutamide
K1 metastasis-free survival
K1 nonmetastatic
K1 prostate-specific antigen
K1 PSA progression
K1 Spain
K1 Spanish
AB 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.
PB Newlands Press
SN 1479-6694
YR 2023
FD 2023-05-24
LK http://hdl.handle.net/10498/31131
UL http://hdl.handle.net/10498/31131
LA eng
DS Repositorio Institucional de la Universidad de Cádiz
RD 10-nov-2026