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

被引：0

作者：

Carles, Joan ^{[1
]}

Medina-Lopez, Rafael A. ^{[2
]}

Puente, Javier ^{[3
]}

Gomez-Ferrer, Alvaro ^{[4
]}

Nebra, Javier Casas ^{[5
]}

Medina, Maria Isabel Saez ^{[6
]}

Ribal, Maria J. ^{[7
]}

Antolin, Alfredo Rodriguez ^{[8
]}

Alvarez-Ossorio, Jose Luis ^{[9
]}

Novo, Jose Francisco Suarez ^{[10
]}

Agut, Cristina Moretones ^{[11
]}

Srinivasan, Shankar ^{[12
]}

Ortiz, Jorge ^{[12
]}

Fizazi, Karim ^{[13
]}

机构：

[1] Hosp Univ Vall Hebron, Vall Hebron Inst Oncol, Barcelona, Spain

[2] Virgen Rocio Univ Hosp, Urol Dept, Seville, Spain

[3] Hosp Clin San Carlos, Inst Invest Sanitaria Hosp Clin San Carlos IdISSC, Med Oncol Dept, CIBERONC, Madrid, Spain

[4] Inst Valenciano Oncol, Valencia, Spain

[5] Hosp Univ Lucus Augusti, Lugo, Spain

[6] Hosp Reg & Univ Virgen Victoria, UGCI Med Oncol, IBIMA, UMA, Malaga, Spain

[7] Univ Barcelona, Hosp Clin, Uro Oncol Unit, Barcelona, Spain

[8] Hosp Univ 12 Octubre, Madrid, Spain

[9] Puerta Mar Univ Hosp, Dept Urol, Cadiz, Spain

[10] Hosp Univ Bellvitge, Lhospitalet De Llobregat, Spain

[11] Bayer Hispania SL, Sant Joan Despi, Spain

[12] Bayer HealthCare, Whippany, NJ 07981 USA

[13] Univ Paris Saclay, Inst Gustave Roussy, Villejuif, France

来源：

FUTURE ONCOLOGY | 2023年 / 19卷 / 12期

关键词：

androgen receptor inhibitor; castration-resistant prostate cancer; darolutamide; metastasis-free survival; nonmetastatic; prostate-specific antigen; PSA progression; Spain; Spanish; METASTASIS-FREE SURVIVAL; MEN;

D O I：

10.2217/fon-2022-1131

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：819 / 828

页数：10

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