Portal de investigação
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.
Autores da FMUP
Participantes de fora da FMUP
- Khoury K
- Lynce F
- Barac A
- Geng X
- Dang C
- Yu AF
- Smith KL
- Gallagher C
- Pohlmann PR
- Herbolsheimer P
- Warren R
- Srichai MB
- Hofmeyer M
- Asch F
- Tan M
- Isaacs C
- Swain SM
Unidades de investigação
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.
Dados da publicação
- ISSN/ISSNe:
- 0167-6806, 1573-7217
- Tipo:
- Article
- Páginas:
- 863-868
Breast Cancer Research and Treatment Springer New York
Documentos
- Não há documentos
Filiações
Keywords
- Breast cancer; Cardiac dysfunction; Cardiac safety; Cardioprotective medications; HER2-targeted therapy
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Citar a publicação
Khoury K,Lynce F,Barac A,Geng X,Dang C,Yu AF,Smith KL,Gallagher C,Pohlmann PR,Nunes R,Herbolsheimer P,Warren R,Srichai MB,Hofmeyer M,Asch F,Tan M,Isaacs C,Swain SM. 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. Breast Cancer Res. Treat. 2021. 185. (3):p. 863-868. IF:4,624. (2).
