%0 Journal Article 
%A Carles, Joan
%A Medina Lopez, Rafael A.
%A Puente, Javier
%A Gómez Ferrer, Álvaro
%A Casas Nebra, Javier
%A Sáez Medina, María Isabel
%A Ribal, Maria J.
%A Rodríguez Antolín, Alfredo
%A Álvarez-Ossorio Fernández, José Luis
%A Suárez Novo, José Francisco
%A Moretones Agut, Cristina
%A Srinivasan, Shankar
%A Ortiz, Jorge
%A Fizazi, Karim
%T Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis
%D 2023
%@ 1479-6694
%U http://hdl.handle.net/10498/31131
%X 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.
%K androgen receptor inhibitor
%K castration-resistant prostate cancer
%K darolutamide
%K metastasis-free survival
%K nonmetastatic
%K prostate-specific antigen
%K PSA progression
%K Spain
%K Spanish
%~ Universidad de Cádiz