Cargando…

Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data

Background and Objective: Radium-223 dichloride (Xofigo(®)) is a calcium mimetic agent approved for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease. This targeted, α-particle-emitting therapy has demonstrated si...

Descripción completa

Detalles Bibliográficos
Autores principales: Soldatos, Theodoros G., Iakovou, Ioannis, Sachpekidis, Christos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6572036/
https://www.ncbi.nlm.nih.gov/pubmed/31100964
http://dx.doi.org/10.3390/medicina55050149
_version_ 1783427548238053376
author Soldatos, Theodoros G.
Iakovou, Ioannis
Sachpekidis, Christos
author_facet Soldatos, Theodoros G.
Iakovou, Ioannis
Sachpekidis, Christos
author_sort Soldatos, Theodoros G.
collection PubMed
description Background and Objective: Radium-223 dichloride (Xofigo(®)) is a calcium mimetic agent approved for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease. This targeted, α-particle-emitting therapy has demonstrated significant survival benefit accompanied by a favorable safety profile. Nevertheless, recent evidence suggests that its combined use with abiraterone and prednisone/prednisolone may be associated with increased risk of death and fractures. While the precise pathophysiologic mechanisms of these events are not yet clear, collecting evidence from more clinical trials and translational studies is necessary. The aim of our present study is to assess whether accessible sources of patient outcome data can help gain additional clinical insights to radium-223 dichloride’s safety profile. Materials and Methods: We performed a retrospective analysis of cases extracted from the FDA Adverse Event Reporting System and characterized side effect occurrence by using reporting ratios. Results: A total of ~1500 prostate cancer patients treated with radium-223 dichloride was identified, and side effects reported with the use of radium-223 dichloride alone or in combination with other therapeutic agents were extracted. Our analysis demonstrates that radium-223 dichloride may often come with hematological-related reactions, and that, when administered together with other drugs, its safety profile may differ. Conclusions: While more prospective studies are needed to fully characterize the toxicological profile of radium-223 dichloride, the present work constitutes perhaps the first effort to examine its safety when administered alone and in combination with other agents based on computational evidence from public real-world post marketing data.
format Online
Article
Text
id pubmed-6572036
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-65720362019-06-18 Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data Soldatos, Theodoros G. Iakovou, Ioannis Sachpekidis, Christos Medicina (Kaunas) Article Background and Objective: Radium-223 dichloride (Xofigo(®)) is a calcium mimetic agent approved for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease. This targeted, α-particle-emitting therapy has demonstrated significant survival benefit accompanied by a favorable safety profile. Nevertheless, recent evidence suggests that its combined use with abiraterone and prednisone/prednisolone may be associated with increased risk of death and fractures. While the precise pathophysiologic mechanisms of these events are not yet clear, collecting evidence from more clinical trials and translational studies is necessary. The aim of our present study is to assess whether accessible sources of patient outcome data can help gain additional clinical insights to radium-223 dichloride’s safety profile. Materials and Methods: We performed a retrospective analysis of cases extracted from the FDA Adverse Event Reporting System and characterized side effect occurrence by using reporting ratios. Results: A total of ~1500 prostate cancer patients treated with radium-223 dichloride was identified, and side effects reported with the use of radium-223 dichloride alone or in combination with other therapeutic agents were extracted. Our analysis demonstrates that radium-223 dichloride may often come with hematological-related reactions, and that, when administered together with other drugs, its safety profile may differ. Conclusions: While more prospective studies are needed to fully characterize the toxicological profile of radium-223 dichloride, the present work constitutes perhaps the first effort to examine its safety when administered alone and in combination with other agents based on computational evidence from public real-world post marketing data. MDPI 2019-05-16 /pmc/articles/PMC6572036/ /pubmed/31100964 http://dx.doi.org/10.3390/medicina55050149 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Soldatos, Theodoros G.
Iakovou, Ioannis
Sachpekidis, Christos
Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title_full Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title_fullStr Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title_full_unstemmed Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title_short Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
title_sort retrospective toxicological profiling of radium-223 dichloride for the treatment of bone metastases in prostate cancer using adverse event data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6572036/
https://www.ncbi.nlm.nih.gov/pubmed/31100964
http://dx.doi.org/10.3390/medicina55050149
work_keys_str_mv AT soldatostheodorosg retrospectivetoxicologicalprofilingofradium223dichlorideforthetreatmentofbonemetastasesinprostatecancerusingadverseeventdata
AT iakovouioannis retrospectivetoxicologicalprofilingofradium223dichlorideforthetreatmentofbonemetastasesinprostatecancerusingadverseeventdata
AT sachpekidischristos retrospectivetoxicologicalprofilingofradium223dichlorideforthetreatmentofbonemetastasesinprostatecancerusingadverseeventdata