Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy Journal Article
| Authors: | Yu, A. F.; Dang, C. T.; Jorgensen, J.; Moskowitz, C. S.; DeFusco, P.; Oligino, E.; Oeffinger, K. C.; Liu, J. E.; Steingart, R. M. |
| Article Title: | Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy |
| Abstract: | 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. © 2023, The Author(s). |
| Keywords: | adult; treatment outcome; young adult; major clinical study; treatment duration; outcome assessment; follow up; evidence based medicine; breast cancer; incidence; epidermal growth factor receptor 2; patient monitoring; cancer therapy; heart death; heart failure; cardiotoxicity; patient safety; echocardiography; risk reduction; heart left ventricle ejection fraction; heart function; process design; human epidermal growth factor receptor 2 positive breast cancer; human; female; article; cardio-oncology; treatment interruption; global longitudinal strain; heart performance; left ventricular systolic pressure |
| Journal Title: | Cardio-Oncology |
| Volume: | 9 |
| ISSN: | 2057-3804 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2023-01-01 |
| Start Page: | 13 |
| Language: | English |
| DOI: | 10.1186/s40959-023-00163-4 |
| PROVIDER: | scopus |
| PMCID: | PMC9996968 |
| PUBMED: | 36895062 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Corresponding author is MSK author: Anthony F. Yu -- Source: Scopus |
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