Identification of target small molecule tyrosine kinase inhibitors that need monitoring and clinical application of protocol for early detection of cancer therapeutics-related cardiac dysfunction using signal detection: An investigation of real world data.

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
Takahito MizunoFumiko Ohtsu

Abstract

In order to detect cancer therapeutics-related cardiac dysfunction (CTRCD) early, we identified which drugs were to be monitored using signal detection and the package insert, and created and applied a protocol to address this. Adverse event data recorded in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and January 2018 were used. Among small molecule tyrosine kinase inhibitors that are not described in the serious side-effects section of the package insert despite signal detection, tyrosine kinase inhibitors with severe side-effects in the background of cases reported by JADER database were selected to be monitored in clinical practice. We applied our findings clinically by creating a protocol to detect CTRCD early. All cases at Tosei General Hospital where the target tyrosine kinase inhibitors were administered from when they were first released in November 2019 were included. We compared the results from before and after we began the protocol to clarify its effects. We found that CTRCD was not described in the serious side-effect section of the package inserts for Bosutinib, Alectinib, and Osimertinib even though CTRCD signals were detected for them. Therefore, it is possible that we may have pre...Continue Reading

References

Jun 3, 2008·Journal of Cardiac Failure·Maya GuglinJoseph D Mishkin
Apr 14, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David MarinJamshid S Khorashad
Aug 19, 2010·Circulation Journal : Official Journal of the Japanese Circulation Society·Manabu MinamiHisanori Horiuchi
Sep 16, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Javid J Moslehi, Michael Deininger
Mar 19, 2016·Circulation Research·Carrie G Lenneman, Douglas B Sawyer
Oct 13, 2016·The New England Journal of Medicine·Javid J Moslehi

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Citations

Dec 6, 2020·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Kei KunimasaToru Kumagai

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Software Mentioned

Osi
JADER
MedDRA
SPSS

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