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 (2019). Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data. Medicina, 55(5) MDPI 10.3390/medicina55050149

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Background andObjective: 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 andMethods: 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Clinic of Nuclear Medicine

UniBE Contributor:

Sachpekidis, Christos

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1648-9144

Publisher:

MDPI

Language:

English

Submitter:

Sabine Lanz

Date Deposited:

18 Dec 2019 10:10

Last Modified:

18 Dec 2019 10:10

Publisher DOI:

10.3390/medicina55050149

PubMed ID:

31100964

Uncontrolled Keywords:

bone metastases data mining pharmacoepidemiology proportional reporting ratio prostate cancer radium-223 dichloride (Xofigo®) real world data side effects

BORIS DOI:

10.7892/boris.137009

URI:

https://boris.unibe.ch/id/eprint/137009

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