The english version of the website is under development. Wherever text appears in Greek, it means it has not been translated yet.

Δημοσίευση

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

TitleRetrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data.
Publication TypeJournal Article
Year of Publication2019
AuthorsSoldatos, T. G., Iakovou I., & Sachpekidis C.
JournalMedicina (Kaunas)
Volume55
Issue5
Date Published2019 May 16
ISSN1648-9144
KeywordsAdult, Antineoplastic Agents, Drug-Related Side Effects and Adverse Reactions, Humans, Male, Neoplasm Metastasis, Prospective Studies, Prostatic Neoplasms, Radium, Retrospective Studies, Survival Analysis, Treatment Outcome
Abstract

: 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. : 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.

DOI10.3390/medicina55050149
Alternate JournalMedicina (Kaunas)
PubMed ID31100964
PubMed Central IDPMC6572036

Contact

Secretariat of the School of Medicine
 

Connect

School of Medicine's presence in social networks
Follow Us or Connect with us.