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Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy
BACKGROUND: Echocardiograms are recommended every 3 months in patients receiving human epidermal growth factor 2 (HER2)-targeted therapy for surveillance of left ventricular ejection fraction (LVEF). Efforts to tailor treatment for HER2-positive breast cancer have led to greater use of non-anthracyc...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9996968/ https://www.ncbi.nlm.nih.gov/pubmed/36895062 http://dx.doi.org/10.1186/s40959-023-00163-4 |
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author | Yu, Anthony F. Dang, Chau T. Jorgensen, Justine Moskowitz, Chaya S. DeFusco, Patricia Oligino, Eric Oeffinger, Kevin C. Liu, Jennifer E. Steingart, Richard M. |
author_facet | Yu, Anthony F. Dang, Chau T. Jorgensen, Justine Moskowitz, Chaya S. DeFusco, Patricia Oligino, Eric Oeffinger, Kevin C. Liu, Jennifer E. Steingart, Richard M. |
author_sort | Yu, Anthony F. |
collection | PubMed |
description | BACKGROUND: Echocardiograms are recommended every 3 months in patients receiving human epidermal growth factor 2 (HER2)-targeted therapy for surveillance of left ventricular ejection fraction (LVEF). Efforts to tailor treatment for HER2-positive breast cancer have led to greater use of non-anthracycline regimens that are associated with lower cardiotoxicity risk, raising into question the need for frequent cardiotoxicity surveillance for these patients. This study seeks to evaluate whether less frequent cardiotoxicity surveillance (every 6 months) is safe for patients receiving a non-anthracycline HER2-targeted treatment regimen. METHODS/DESIGN: We will enroll 190 women with histologically confirmed HER2-positive breast cancer scheduled to receive a non-anthracycline HER2-targeted treatment regimen for a minimum of 12 months. All participants will undergo echocardiograms before and 6-, 12-, and 18-months after initiation of HER2-targeted treatment. The primary composite outcome is symptomatic heart failure (New York Heart Association class III or IV) or death from cardiovascular causes. Secondary outcomes include: 1) echocardiographic indices of left ventricular systolic function; 2) incidence of cardiotoxicity, defined by a ≥ 10% absolute reduction in left ventricular ejection fraction (LVEF) from baseline to < 53%; and 3) incidence of early interruption of HER2-targeted therapy. CONCLUSIONS: To our knowledge, this will be the first prospective study of a risk-based approach to cardiotoxicity surveillance. We expect findings from this study will inform the development of updated clinical practice guidelines to improve cardiotoxicity surveillance practices during HER2-positive breast cancer treatment. TRIAL REGISTRATION: The trial was registered in the ClinicalTrials.gov registry (identifier NCT03983382) on June 12, 2019. |
format | Online Article Text |
id | pubmed-9996968 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-99969682023-03-10 Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy Yu, Anthony F. Dang, Chau T. Jorgensen, Justine Moskowitz, Chaya S. DeFusco, Patricia Oligino, Eric Oeffinger, Kevin C. Liu, Jennifer E. Steingart, Richard M. Cardiooncology Research BACKGROUND: Echocardiograms are recommended every 3 months in patients receiving human epidermal growth factor 2 (HER2)-targeted therapy for surveillance of left ventricular ejection fraction (LVEF). Efforts to tailor treatment for HER2-positive breast cancer have led to greater use of non-anthracycline regimens that are associated with lower cardiotoxicity risk, raising into question the need for frequent cardiotoxicity surveillance for these patients. This study seeks to evaluate whether less frequent cardiotoxicity surveillance (every 6 months) is safe for patients receiving a non-anthracycline HER2-targeted treatment regimen. METHODS/DESIGN: We will enroll 190 women with histologically confirmed HER2-positive breast cancer scheduled to receive a non-anthracycline HER2-targeted treatment regimen for a minimum of 12 months. All participants will undergo echocardiograms before and 6-, 12-, and 18-months after initiation of HER2-targeted treatment. The primary composite outcome is symptomatic heart failure (New York Heart Association class III or IV) or death from cardiovascular causes. Secondary outcomes include: 1) echocardiographic indices of left ventricular systolic function; 2) incidence of cardiotoxicity, defined by a ≥ 10% absolute reduction in left ventricular ejection fraction (LVEF) from baseline to < 53%; and 3) incidence of early interruption of HER2-targeted therapy. CONCLUSIONS: To our knowledge, this will be the first prospective study of a risk-based approach to cardiotoxicity surveillance. We expect findings from this study will inform the development of updated clinical practice guidelines to improve cardiotoxicity surveillance practices during HER2-positive breast cancer treatment. TRIAL REGISTRATION: The trial was registered in the ClinicalTrials.gov registry (identifier NCT03983382) on June 12, 2019. BioMed Central 2023-03-09 /pmc/articles/PMC9996968/ /pubmed/36895062 http://dx.doi.org/10.1186/s40959-023-00163-4 Text en © The Author(s) 2023 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 Yu, Anthony F. Dang, Chau T. Jorgensen, Justine Moskowitz, Chaya S. DeFusco, Patricia Oligino, Eric Oeffinger, Kevin C. Liu, Jennifer E. Steingart, Richard M. Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title_full | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title_fullStr | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title_full_unstemmed | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title_short | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
title_sort | rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during her2-targeted therapy |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9996968/ https://www.ncbi.nlm.nih.gov/pubmed/36895062 http://dx.doi.org/10.1186/s40959-023-00163-4 |
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