Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
<i>Background and </i><i>O</i><i>bjective</i>: 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...
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doaj-d2cbf01f37dc420c9b6bb43e250e8de32020-11-25T00:58:05ZengMDPI AGMedicina1010-660X2019-05-0155514910.3390/medicina55050149medicina55050149Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event DataTheodoros G. Soldatos0Ioannis Iakovou1Christos Sachpekidis2Molecular Health GmbH, Heidelberg, GermanyDepartment of Nuclear Medicine, Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, GreeceDepartment of Nuclear Medicine, Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, Greece<i>Background and </i><i>O</i><i>bjective</i>: 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. <i>M</i><i>aterials and</i><i> M</i><i>ethods</i>: 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.https://www.mdpi.com/1010-660X/55/5/149prostate cancerbone metastasesradium-223 dichloride (Xofigo®)side effectsreal world datadata miningpharmacoepidemiologyproportional reporting ratio |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Theodoros G. Soldatos Ioannis Iakovou Christos Sachpekidis |
spellingShingle |
Theodoros G. Soldatos Ioannis Iakovou Christos Sachpekidis Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data Medicina prostate cancer bone metastases radium-223 dichloride (Xofigo®) side effects real world data data mining pharmacoepidemiology proportional reporting ratio |
author_facet |
Theodoros G. Soldatos Ioannis Iakovou Christos Sachpekidis |
author_sort |
Theodoros G. Soldatos |
title |
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_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_sort |
retrospective toxicological profiling of radium-223 dichloride for the treatment of bone metastases in prostate cancer using adverse event data |
publisher |
MDPI AG |
series |
Medicina |
issn |
1010-660X |
publishDate |
2019-05-01 |
description |
<i>Background and </i><i>O</i><i>bjective</i>: 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. <i>M</i><i>aterials and</i><i> M</i><i>ethods</i>: 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. |
topic |
prostate cancer bone metastases radium-223 dichloride (Xofigo®) side effects real world data data mining pharmacoepidemiology proportional reporting ratio |
url |
https://www.mdpi.com/1010-660X/55/5/149 |
work_keys_str_mv |
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