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

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

doi:10.2217/fon-2022-1131

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

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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	819-828
Number of pages	10
Journal	Future Oncology
Volume	19
Issue number	12
DOIs	https://doi.org/10.2217/fon-2022-1131
Publication status	Published - 1 Apr 2023

Keywords

PSA progression
Spain
Spanish
androgen receptor inhibitor
castration-resistant prostate cancer
darolutamide
metastasis-free survival
nonmetastatic
prostate-specific antigen

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Carles, J., Medina-Lopez, R. A., Puente, J., Gómez-Ferrer, Á., Nebra, J. C., Sáez Medina, M. I., Ribal, M. J., Antolín, A. R., Álvarez-Ossorio, J. L., Suárez Novo, J. F., Agut, C. M., Srinivasan, S., Ortiz, J., & Fizazi, K. (2023). Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis. Future Oncology, 19(12), 819-828. https://doi.org/10.2217/fon-2022-1131

@article{1b51e4325fed4f3b8e6f4f969da9a28d,

title = "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.",

keywords = "PSA progression, Spain, Spanish, androgen receptor inhibitor, castration-resistant prostate cancer, darolutamide, metastasis-free survival, nonmetastatic, prostate-specific antigen",

author = "Joan Carles and Medina-Lopez, {Rafael A.} and Javier Puente and {\'A}lvaro G{\'o}mez-Ferrer and Nebra, {Javier Casas} and {S{\'a}ez Medina}, {Mar{\'i}a Isabel} and Ribal, {Maria J.} and Antol{\'i}n, {Alfredo Rodr{\'i}guez} and {\'A}lvarez-Ossorio, {Jos{\'e} Lu{\'i}s} and {Su{\'a}rez Novo}, {Jos{\'e} Francisco} and Agut, {Cristina Moretones} and Shankar Srinivasan and Jorge Ortiz and Karim Fizazi",

note = "Publisher Copyright: {\textcopyright} 2023 The Authors.",

year = "2023",

month = apr,

day = "1",

doi = "10.2217/fon-2022-1131",

language = "English",

volume = "19",

pages = "819--828",

journal = "Future Oncology",

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Carles, J, Medina-Lopez, RA, Puente, J, Gómez-Ferrer, Á, Nebra, JC, Sáez Medina, MI, Ribal, MJ, Antolín, AR, Álvarez-Ossorio, JL, Suárez Novo, JF, Agut, CM, Srinivasan, S, Ortiz, J & Fizazi, K 2023, 'Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis', Future Oncology, vol. 19, no. 12, pp. 819-828. https://doi.org/10.2217/fon-2022-1131

TY - JOUR

T1 - Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer

T2 - ARAMIS subgroup analysis

AU - Carles, Joan

AU - Medina-Lopez, Rafael A.

AU - Puente, Javier

AU - Gómez-Ferrer, Álvaro

AU - Nebra, Javier Casas

AU - Sáez Medina, María Isabel

AU - Ribal, Maria J.

AU - Antolín, Alfredo Rodríguez

AU - Álvarez-Ossorio, José Luís

AU - Suárez Novo, José Francisco

AU - Agut, Cristina Moretones

AU - Srinivasan, Shankar

AU - Ortiz, Jorge

AU - Fizazi, Karim

PY - 2023/4/1

Y1 - 2023/4/1

N2 - 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.

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. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov.

KW - PSA progression

KW - Spain

KW - Spanish

KW - androgen receptor inhibitor

KW - castration-resistant prostate cancer

KW - darolutamide

KW - metastasis-free survival

KW - nonmetastatic

KW - prostate-specific antigen

UR - http://www.scopus.com/inward/record.url?scp=85162225721&partnerID=8YFLogxK

U2 - 10.2217/fon-2022-1131

DO - 10.2217/fon-2022-1131

M3 - Article

C2 - 37222151

AN - SCOPUS:85162225721

SN - 1479-6694

VL - 19

SP - 819

EP - 828

JO - Future Oncology

JF - Future Oncology

IS - 12

ER -

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

Abstract

Keywords

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