Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial

Background: The EORTC 1333 'PEACE-3' study investigated the combination of enzalutamide and 6 monthly injections of radium-223 (Ra223) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. Materials and methods: From November 2015 to March 2023, 446...

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Autores: Tombal, B, Choudhury, A, Saad, F, Gallardo, E, Soares, A, Loriot, Y, Mcdermott, R, Rodriguez-Vida, A, Velho, PI, Nolè, F, Cruz, F, Roumeguere, T, Daugaard, G, Yamamura, R, Bompas, E, Maroto, P, Veiga, FG, Skoneczna, I, Trindade, KMD, Carcano, FM, Lecouvet, F, Coens, C, Poncet, C, Fournier, B, Gillessen, S, Crua, F
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p6632
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/6632
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105006947485&doi=10.1016%2Fj.annonc.2025.05.011&partnerID=40&md5=d4ecc7e05bcc523b370649733199ba59
Access Level:acceso abierto
Palabra clave:metastatic castration-resistant prostate cancer
bone metastases
radium-223
enzalutamide
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spelling Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trialTombal, BChoudhury, ASaad, FGallardo, ESoares, ALoriot, YMcdermott, RRodriguez-Vida, AVelho, PINolè, FCruz, FRoumeguere, TDaugaard, GYamamura, RBompas, EMaroto, PVeiga, FGSkoneczna, ITrindade, KMDCarcano, FMLecouvet, FCoens, CPoncet, CFournier, BGillessen, SCrua, Fmetastatic castration-resistant prostate cancerbone metastasesradium-223enzalutamideBackground: The EORTC 1333 'PEACE-3' study investigated the combination of enzalutamide and 6 monthly injections of radium-223 (Ra223) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. Materials and methods: From November 2015 to March 2023, 446 patients, including 11 who received abiraterone, were randomized to enzalutamide (without placebo) or enzalutamide combined with six cycles of Ra223. As of March 2018, the co-administration of zoledronic acid or denosumab was mandatory. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. Results: The hazard ratio (HR) for rPFS was 0.69 [95% confidence interval (CI) 0.54-0.87, P = 0.0009], with a median rPFS of 16.4 months (95% CI 13.8-19.2 months) in the enzalutamide arm and 19.4 months (95% CI 17.1-25.3 months) in the combination arm. At the preplanned interim analysis conducted at 80% of the OS events, the HR for OS was 0.69 (95% CI 0.52-0.90, P = 0.0031), with a median OS of 35.0 months (95% CI 28.8-38.9 months) in the enzalutamide arm and 42.3 months (95% CI 36.8-49.1 months) in the combination arm. Due to non-proportional hazards, this will be tested further at the final OS analysis. Treatment-emergent adverse events (TEAEs) > grade 3 were recorded in 55.8% and 65.6% of the patients in the enzalutamide and combination arms, respectively. The most frequent grade >3 TEAEs in the combination arm were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%), and neutropenia (5%). Fractures [either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without bone-protecting agent (BPA) use] were reported in 30 (13.4%) patients in the enzalutamide arm and 53 patients (24.3%) in the combination arm. Conclusion: PEACE-3 demonstrates that combining enzalutamide with Ra223 as first-line therapy for mCRPC significantly improves rPFS. Although statistically significant at the OS interim boundary, the study will continue to the final OS analysis.ELSEVIER2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/6632https://www.scopus.com/inward/record.uri?eid=2-s2.0-105006947485&doi=10.1016%2Fj.annonc.2025.05.011&partnerID=40&md5=d4ecc7e05bcc523b370649733199ba59ANNALS OF ONCOLOGYISSN: 09237534ISSNe: 15698041reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p66322026-06-21T15:30:37Z
dc.title.none.fl_str_mv Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
title Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
spellingShingle Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
Tombal, B
metastatic castration-resistant prostate cancer
bone metastases
radium-223
enzalutamide
title_short Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
title_full Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
title_fullStr Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
title_full_unstemmed Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
title_sort Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial
dc.creator.none.fl_str_mv Tombal, B
Choudhury, A
Saad, F
Gallardo, E
Soares, A
Loriot, Y
Mcdermott, R
Rodriguez-Vida, A
Velho, PI
Nolè, F
Cruz, F
Roumeguere, T
Daugaard, G
Yamamura, R
Bompas, E
Maroto, P
Veiga, FG
Skoneczna, I
Trindade, KMD
Carcano, FM
Lecouvet, F
Coens, C
Poncet, C
Fournier, B
Gillessen, S
Crua, F
author Tombal, B
author_facet Tombal, B
Choudhury, A
Saad, F
Gallardo, E
Soares, A
Loriot, Y
Mcdermott, R
Rodriguez-Vida, A
Velho, PI
Nolè, F
Cruz, F
Roumeguere, T
Daugaard, G
Yamamura, R
Bompas, E
Maroto, P
Veiga, FG
Skoneczna, I
Trindade, KMD
Carcano, FM
Lecouvet, F
Coens, C
Poncet, C
Fournier, B
Gillessen, S
Crua, F
author_role author
author2 Choudhury, A
Saad, F
Gallardo, E
Soares, A
Loriot, Y
Mcdermott, R
Rodriguez-Vida, A
Velho, PI
Nolè, F
Cruz, F
Roumeguere, T
Daugaard, G
Yamamura, R
Bompas, E
Maroto, P
Veiga, FG
Skoneczna, I
Trindade, KMD
Carcano, FM
Lecouvet, F
Coens, C
Poncet, C
Fournier, B
Gillessen, S
Crua, F
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv metastatic castration-resistant prostate cancer
bone metastases
radium-223
enzalutamide
topic metastatic castration-resistant prostate cancer
bone metastases
radium-223
enzalutamide
description Background: The EORTC 1333 'PEACE-3' study investigated the combination of enzalutamide and 6 monthly injections of radium-223 (Ra223) in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. Materials and methods: From November 2015 to March 2023, 446 patients, including 11 who received abiraterone, were randomized to enzalutamide (without placebo) or enzalutamide combined with six cycles of Ra223. As of March 2018, the co-administration of zoledronic acid or denosumab was mandatory. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. Results: The hazard ratio (HR) for rPFS was 0.69 [95% confidence interval (CI) 0.54-0.87, P = 0.0009], with a median rPFS of 16.4 months (95% CI 13.8-19.2 months) in the enzalutamide arm and 19.4 months (95% CI 17.1-25.3 months) in the combination arm. At the preplanned interim analysis conducted at 80% of the OS events, the HR for OS was 0.69 (95% CI 0.52-0.90, P = 0.0031), with a median OS of 35.0 months (95% CI 28.8-38.9 months) in the enzalutamide arm and 42.3 months (95% CI 36.8-49.1 months) in the combination arm. Due to non-proportional hazards, this will be tested further at the final OS analysis. Treatment-emergent adverse events (TEAEs) > grade 3 were recorded in 55.8% and 65.6% of the patients in the enzalutamide and combination arms, respectively. The most frequent grade >3 TEAEs in the combination arm were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%), and neutropenia (5%). Fractures [either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without bone-protecting agent (BPA) use] were reported in 30 (13.4%) patients in the enzalutamide arm and 53 patients (24.3%) in the combination arm. Conclusion: PEACE-3 demonstrates that combining enzalutamide with Ra223 as first-line therapy for mCRPC significantly improves rPFS. Although statistically significant at the OS interim boundary, the study will continue to the final OS analysis.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://i3pt.portalinvestigacion.com/publicaciones/6632
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105006947485&doi=10.1016%2Fj.annonc.2025.05.011&partnerID=40&md5=d4ecc7e05bcc523b370649733199ba59
url https://i3pt.portalinvestigacion.com/publicaciones/6632
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105006947485&doi=10.1016%2Fj.annonc.2025.05.011&partnerID=40&md5=d4ecc7e05bcc523b370649733199ba59
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER
publisher.none.fl_str_mv ELSEVIER
dc.source.none.fl_str_mv ANNALS OF ONCOLOGY
ISSN: 09237534
ISSNe: 15698041
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
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