Carvedilol Effect in Preventing Chemotherapy Induced CardiotoxicitY - CECCY
Contribution To Literature:
The CECCY trial failed to show that carvedilol was superior to placebo at preventing cardiomyopathy.
The goal of the trial was to evaluate carvedilol compared with placebo among patients with HER2-negative breast cancer undergoing anthracycline-based chemotherapy.
Patients with HER2-negative breast cancer undergoing anthracycline-based chemotherapy were randomized to carvedilol (n = 96) versus placebo (n = 96). Study medication was up-titrated to 25 mg twice daily if tolerated.
- Total number of enrollees: 192
- Duration of follow-up: 24 weeks
- Mean patient age: 51 years
- Percentage female: 100%
- Percentage with diabetes: 4%
- Women ≥18 years of age
- Invasive adenocarcinoma
- Undergoing adjuvant or neoadjuvant chemotherapy, including an anthracycline (240 mg/m2)
- Prior history of chemotherapy or radiation
- Heart failure symptoms or prior history of cardiomyopathy
- Coronary artery disease
- Moderate to severe mitral or aortic disease
- Use of angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker, or bea-blockers
- Contraindication to beta-blockers
- Patients with HER2 expression
The primary endpoint, prevention of a ≥10% reduction in left ventricular ejection fraction (LVEF) at 6 months, occurred in 14.5% of the carvedilol group versus 13.5% of the placebo group (p = 1.0).
- Percentage of patients with troponin I ≥0.04: 26.0% vs. 41.6% (p = 0.003)
- Percentage of patients with abnormal diastolic function at follow-up: 28.5% vs. 37.2% (p = 0.039)
Among patients with invasive breast cancer undergoing anthracycline-based chemotherapy, carvedilol versus placebo was not effective at preventing a reduction in LVEF. Carvedilol was associated with a lower frequency of detectable troponin I values and abnormal diastolic dysfunction. While this is the largest trial on the topic, it was still underpowered to be able to detect a difference in outcomes between treatment groups.
Avila MS, Ayub-Ferreira SM, Junior MR, et al. Carvedilol for Prevention of Chemotherapy Related Cardiotoxicity. J Am Coll Cardiol 2018;Mar 11:[Epub ahead of print.
Presented by Dr. Monica Avila at the American College of Cardiology Annual Scientific Session (ACC 2018), Orlando, FL, March 11, 2018.
Keywords: ACC18, ACC Annual Scientific Session, Adenocarcinoma, Anthracyclines, Breast Neoplasms, Cardiomyopathies, Cardiotoxicity, Chemotherapy, Adjuvant, Diastole, Heart Failure, Neoadjuvant Therapy, Primary Prevention, Stroke Volume, Troponin I, Women
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