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A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors
BACKGROUND: Modern therapies in oncology have increased cancer survivorship, as well as the incidence of cardiovascular adverse events. While immune checkpoint inhibitors have shown significant clinical impact in several cancer types, the incidence of immune-related cardiovascular (CV) adverse event...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161966/ https://www.ncbi.nlm.nih.gov/pubmed/34049595 http://dx.doi.org/10.1186/s40959-021-00106-x |
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author | Lal, Jessica Castrillon Brown, Sherry-Ann Collier, Patrick Cheng, Feixiong |
author_facet | Lal, Jessica Castrillon Brown, Sherry-Ann Collier, Patrick Cheng, Feixiong |
author_sort | Lal, Jessica Castrillon |
collection | PubMed |
description | BACKGROUND: Modern therapies in oncology have increased cancer survivorship, as well as the incidence of cardiovascular adverse events. While immune checkpoint inhibitors have shown significant clinical impact in several cancer types, the incidence of immune-related cardiovascular (CV) adverse events poses an additional health concern and has been reported. METHODS: We performed a retrospective analysis of the FDA Adverse Event Reporting System data of suspect product reports for immunotherapy and classical chemotherapy from January 2010–March 2020. We identified 90,740 total adverse event reports related to immune checkpoint inhibitors and classical chemotherapy. RESULTS: We found that myocarditis was significantly associated with patients receiving anti-program cell death protein 1 (PD-1) or anti-program death ligand 1 (PD-L1), odds ratio (OR) = 23.86 (95% confidence interval [CI] 11.76–48.42, (adjusted p-value) q < 0.001), and combination immunotherapy, OR = 7.29 (95% CI 1.03–51.89, q = 0.047). Heart failure was significantly associated in chemotherapy compared to PD-(L)1, OR = 0.50 (95% CI 0.37–0.69, q < 0.001), CTLA4, OR = 0.08 (95% CI 0.03–0.20, q < 0.001), and combination immunotherapy, OR = 0.25 (95% CI 0.13–0.48, q < 0.001). Additionally, we observe a sex-specificity towards males in cardiac adverse reports for arrhythmias, OR = 0.81 (95% CI 0.75–0.87, q < 0.001), coronary artery disease, 0.63 (95% CI 0.53–0.76, q < 0.001), myocardial infarction, OR = 0.60 (95% CI 0.53–0.67, q < 0.001), myocarditis, OR = 0.59 (95% CI 0.47–0.75, q < 0.001) and pericarditis, OR = 0.5 (95% CI 0.35–0.73, q < 0.001). CONCLUSION: Our study provides the current risk estimates of cardiac adverse events in patients treated with immunotherapy compared to conventional chemotherapy. Understanding the clinical risk factors that predispose immunotherapy-treated cancer patients to often fatal CV adverse events will be crucial in Cardio-Oncology management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40959-021-00106-x. |
format | Online Article Text |
id | pubmed-8161966 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-81619662021-06-01 A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors Lal, Jessica Castrillon Brown, Sherry-Ann Collier, Patrick Cheng, Feixiong Cardiooncology Research BACKGROUND: Modern therapies in oncology have increased cancer survivorship, as well as the incidence of cardiovascular adverse events. While immune checkpoint inhibitors have shown significant clinical impact in several cancer types, the incidence of immune-related cardiovascular (CV) adverse events poses an additional health concern and has been reported. METHODS: We performed a retrospective analysis of the FDA Adverse Event Reporting System data of suspect product reports for immunotherapy and classical chemotherapy from January 2010–March 2020. We identified 90,740 total adverse event reports related to immune checkpoint inhibitors and classical chemotherapy. RESULTS: We found that myocarditis was significantly associated with patients receiving anti-program cell death protein 1 (PD-1) or anti-program death ligand 1 (PD-L1), odds ratio (OR) = 23.86 (95% confidence interval [CI] 11.76–48.42, (adjusted p-value) q < 0.001), and combination immunotherapy, OR = 7.29 (95% CI 1.03–51.89, q = 0.047). Heart failure was significantly associated in chemotherapy compared to PD-(L)1, OR = 0.50 (95% CI 0.37–0.69, q < 0.001), CTLA4, OR = 0.08 (95% CI 0.03–0.20, q < 0.001), and combination immunotherapy, OR = 0.25 (95% CI 0.13–0.48, q < 0.001). Additionally, we observe a sex-specificity towards males in cardiac adverse reports for arrhythmias, OR = 0.81 (95% CI 0.75–0.87, q < 0.001), coronary artery disease, 0.63 (95% CI 0.53–0.76, q < 0.001), myocardial infarction, OR = 0.60 (95% CI 0.53–0.67, q < 0.001), myocarditis, OR = 0.59 (95% CI 0.47–0.75, q < 0.001) and pericarditis, OR = 0.5 (95% CI 0.35–0.73, q < 0.001). CONCLUSION: Our study provides the current risk estimates of cardiac adverse events in patients treated with immunotherapy compared to conventional chemotherapy. Understanding the clinical risk factors that predispose immunotherapy-treated cancer patients to often fatal CV adverse events will be crucial in Cardio-Oncology management. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40959-021-00106-x. BioMed Central 2021-05-28 /pmc/articles/PMC8161966/ /pubmed/34049595 http://dx.doi.org/10.1186/s40959-021-00106-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Lal, Jessica Castrillon Brown, Sherry-Ann Collier, Patrick Cheng, Feixiong A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title | A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title_full | A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title_fullStr | A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title_full_unstemmed | A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title_short | A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
title_sort | retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161966/ https://www.ncbi.nlm.nih.gov/pubmed/34049595 http://dx.doi.org/10.1186/s40959-021-00106-x |
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