Long-term follow-up assessment of cardiac safety in SAFE-HEaRt, a clinical trial evaluating the use of HER2-targeted therapies in patients with breast cancer and compromised heart function Journal Article
| Authors: | Khoury, K.; Lynce, F.; Barac, A.; Geng, X.; Dang, C.; Yu, A. F.; Smith, K. L.; Gallagher, C.; Pohlmann, P. R.; Nunes, R.; Herbolsheimer, P.; Warren, R.; Srichai, M. B.; Hofmeyer, M.; Asch, F.; Tan, M.; Isaacs, C.; Swain, S. M. |
| Article Title: | Long-term follow-up assessment of cardiac safety in SAFE-HEaRt, a clinical trial evaluating the use of HER2-targeted therapies in patients with breast cancer and compromised heart function |
| Abstract: | Purpose: HER2-targeted therapies are associated with cardiotoxicity which is usually asymptomatic and reversible. We report the updated cardiac safety assessment of patients with compromised heart function receiving HER2-targeted therapy for breast cancer, enrolled in the SAFE-HEaRt trial, at a median follow-up of 3.5 years. Methods: Thirty patients with stage I-IV HER2-positive breast cancer receiving trastuzumab with or without pertuzumab, or ado-trastuzumab emtansine (T-DM1), with asymptomatic LVEF (left ventricular ejection fraction) 40–49%, were started on cardioprotective medications, with the primary endpoint being completion of HER2-targeted therapy without cardiac events (CE) or protocol-defined asymptomatic worsening of LVEF. IRB-approved follow-up assessment included 23 patients. Results: Median follow-up as of June 2020 is 42 months. The study met its primary endpoint with 27 patients (90%) completing their HER2-targeted therapies without cardiac issues. Of the 23 evaluable patients at long-term f/u, 14 had early stage breast cancer, and 9 had metastatic disease, 8 of whom remained on HER2-targeted therapies. One patient developed symptomatic heart failure with no change in LVEF. There were no cardiac deaths. The mean LVEF improved to 52.1% from 44.9% at study baseline, including patients who remained on HER2-targeted therapy, and those who received prior anthracyclines. Conclusions: Long-term follow-up of the SAFE-HEaRt study continues to provide safety data of HER2-targeted therapy use in patients with compromised heart function. The late development of cardiac dysfunction is uncommon and continued multi-disciplinary oncologic and cardiac care of patients is vital for improved patient outcomes. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature. |
| Keywords: | clinical article; drug safety; treatment duration; cancer staging; follow up; prospective study; breast cancer; heart disease; cancer therapy; risk assessment; heart failure; long term care; trastuzumab; heart left ventricle ejection fraction; metastatic breast cancer; beta adrenergic receptor blocking agent; dipeptidyl carboxypeptidase inhibitor; heart protection; pertuzumab; angiotensin receptor antagonist; heart function; cardiac dysfunction; clinical outcome; her2-targeted therapy; cardiac safety; human; priority journal; article; cardioprotective medications |
| Journal Title: | Breast Cancer Research and Treatment |
| Volume: | 185 |
| Issue: | 3 |
| ISSN: | 0167-6806 |
| Publisher: | Springer |
| Date Published: | 2021-02-01 |
| Start Page: | 863 |
| End Page: | 868 |
| Language: | English |
| DOI: | 10.1007/s10549-020-06053-y |
| PUBMED: | 33400034 |
| PROVIDER: | scopus |
| PMCID: | PMC8207895 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2021 -- Source: Scopus |
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