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Decrease in fracture rate with mandatory bone-protecting agents in the EORTC 1333/PEACE-3 trial comparing radium-223 combined with enzalutamide versus enzalutamide alone: a safety analysis

Gillessen, S.
; 
Tombal, B.
; 
Turco, F.
; 
Choudhury, A.
; 
Rodriguez-Vida, A.
; 
Gallardo, E.
; 
Velho, P. I.
; 
Nolè, F.
; 
Cruz, F.
; 
Loriot, Y.
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Abstract
Bone health is central to the management of patients with metastatic castration-resistant prostate cancer (mCRPC). International guidelines recommend giving a bone-protecting agent (BPA) to patients with mCRPC and bone metastases. However, the data supporting these recommendations were generated before androgen receptor pathway inhibitors (ARPIs) were available. Here we publish for the first time fracture rates from an interim safety analysis of the international prospective phase 3 PEACE-3 trial comparing radium-223 ((223)Ra) combined with enzalutamide for first-line mCPRC to enzalutamide alone. After results from the ERA-223 trial (abiraterone ± (223)Ra) showed a high fracture rate in both arms, the independent data monitoring committee of PEACE-3 mandated BPA use during the trial, which increased BPA use from 46.1% to 97%. For patients who received BPA therapy, fracture rates significantly decreased in both study arms. At 1 year, fractures decreased from 15.6% to 2.6% with a BPA in patients receiving enzalutamide monotherapy. The interim safety analysis of PEACE-3 underscores the high risk of fracture in patients with mCRPC and the necessity of complying with guidelines regarding BPA administration in the ARPI era. The EORTC GUCG-1333 PEACE-3 trial is registered on ClinicalTrials.gov as NCT02194842 and on EudraCT as 2014-001787-36.
Authors
Gillessen, S.
Tombal, B.
Turco, F.
Choudhury, A.
Rodriguez-Vida, A.
Gallardo, E.
Velho, P. I.
Nolè, F.
Cruz, F.
Loriot, Y.
McDermott, R.
Roumeguere, T.
Daugaard, G.
Yamamura, R.
Bompas, E.
Maroto, P.
Polo, M. H.
da Trindade, K. M.
Preto, D. D.
Skoneczna, I.
Lecouvet, F.
Coens, C.
Fournier, B.
Saad, F.
Affiliation
Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; Università della Svizzera Italiana, Lugano, Switzerland. Electronic address: Silke.GillessenSommer@eoc.ch. Cliniques Universitaires Saint Luc, Brussels, Belgium. Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. The Christie NHS Foundation Trust, Manchester, UK. Hospital del Mar, Barcelona, Spain. Hospital Universitari Parc Tauli, Sabadell, Spain. Hospital Moinhos de Vento, Porto Alegre, Brazil. Medical Oncology Division for Urogenital and Head & Neck Tumours, European Institute of Oncology IRCCS, Milan, Italy. Instituto Brasileiro de Controle do Câncer, Sao Paulo, Brazil. Institut Gustave Roussy, Paris, France. St. Vincent's University Hospital, Dublin, Ireland. Hôpital Universitaire de Bruxelles, Jules Bordet Institute and Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. A Beneficência Portuguesa de São Paulo, São Paulo, Brazil. Institut de Cancérologie de l'Ouest, Angers, France. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. Hospital Universitario de Salamanca and Hospital Virgen De la Vega, Salamanca, Spain. Instituto D'Or de Pesquisa e Ensino, Fortaleza, Brazil. Hospital de Amor, Barretos, Brazil. Maria Sklodowska Curie Memorial Cancer Centre, Warsaw, Poland. European Organisation for Research and Treatment of Cancer, Brussels, Belgium. Centre Hospitalier de l'Université de Montréal, Montreal, Canada.
Description
Date
2025
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All Christie Publications
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Article
Citation
Gillessen S, Tombal B, Turco F, Choudhury A, Rodriguez-Vida A, Gallardo E, et al. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-8. PubMed PMID: 39827019. Epub 2025/01/20 22:53. eng.
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https://christie.openrepository.com/handle/10541/627641
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