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Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer

AIM: Utilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic...

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Autores principales: Polychronopoulou, Efstathia, Giordano, Sharon H, Chou, Lin-Na, Yu, Xiaoying, Kuo, Yong-Fang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9177105/
https://www.ncbi.nlm.nih.gov/pubmed/35438771
http://dx.doi.org/10.1093/oncolo/oyac059
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author Polychronopoulou, Efstathia
Giordano, Sharon H
Chou, Lin-Na
Yu, Xiaoying
Kuo, Yong-Fang
author_facet Polychronopoulou, Efstathia
Giordano, Sharon H
Chou, Lin-Na
Yu, Xiaoying
Kuo, Yong-Fang
author_sort Polychronopoulou, Efstathia
collection PubMed
description AIM: Utilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic in detecting adverse drug events (ADEs) attributed to trastuzumab using an administrative claims dataset. METHODS: Using data from the Texas Cancer Registry and SEER linked to Medicare from 2010 to 2013, we conducted 1:2 propensity score matching. Breast cancer HER2+ patients treated with trastuzumab in addition to standard chemotherapy were matched to HER2– patients treated with standard chemotherapy. Inpatient and outpatient encounters up to 6 months from start of therapy were used to identify adverse events. RESULTS: A total of 4191 patients were included in the study. Across all methods, use of trastuzumab generated signals on 9 distinct body systems. Cardiomyopathy and heart valve disease were the most consistently detected signals. Clinical review determined that most signals represented known ADEs. CONCLUSIONS: We showed that claims data can be used to complement current ADE monitoring using common data mining methods with propensity score matching. Our analysis identified all expected ADEs associated with trastuzumab, and additional signals of valvular heart disorders.
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spelling pubmed-91771052022-06-09 Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer Polychronopoulou, Efstathia Giordano, Sharon H Chou, Lin-Na Yu, Xiaoying Kuo, Yong-Fang Oncologist Breast Cancer AIM: Utilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic in detecting adverse drug events (ADEs) attributed to trastuzumab using an administrative claims dataset. METHODS: Using data from the Texas Cancer Registry and SEER linked to Medicare from 2010 to 2013, we conducted 1:2 propensity score matching. Breast cancer HER2+ patients treated with trastuzumab in addition to standard chemotherapy were matched to HER2– patients treated with standard chemotherapy. Inpatient and outpatient encounters up to 6 months from start of therapy were used to identify adverse events. RESULTS: A total of 4191 patients were included in the study. Across all methods, use of trastuzumab generated signals on 9 distinct body systems. Cardiomyopathy and heart valve disease were the most consistently detected signals. Clinical review determined that most signals represented known ADEs. CONCLUSIONS: We showed that claims data can be used to complement current ADE monitoring using common data mining methods with propensity score matching. Our analysis identified all expected ADEs associated with trastuzumab, and additional signals of valvular heart disorders. Oxford University Press 2022-04-18 /pmc/articles/PMC9177105/ /pubmed/35438771 http://dx.doi.org/10.1093/oncolo/oyac059 Text en © The Author(s) 2022. Published by Oxford University Press. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com.
spellingShingle Breast Cancer
Polychronopoulou, Efstathia
Giordano, Sharon H
Chou, Lin-Na
Yu, Xiaoying
Kuo, Yong-Fang
Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title_full Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title_fullStr Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title_full_unstemmed Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title_short Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer
title_sort signal detection of adverse events associated with trastuzumab in a cohort of elderly patients with breast cancer
topic Breast Cancer
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9177105/
https://www.ncbi.nlm.nih.gov/pubmed/35438771
http://dx.doi.org/10.1093/oncolo/oyac059
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