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.
Description:
The goal of the trial was to evaluate carvedilol compared with placebo among patients with HER2-negative breast cancer undergoing anthracycline-based chemotherapy.
Study Design
- Randomized
- Parallel
- Placebo
- Stratified
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%
Inclusion criteria:
- Women ≥18 years of age
- Invasive adenocarcinoma
- Undergoing adjuvant or neoadjuvant chemotherapy, including an anthracycline (240 mg/m2)
Exclusion criteria:
- 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
Principal Findings:
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).
Secondary outcomes:
- 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)
Interpretation:
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.
References:
Avila MS, Ayub-Ferreira SM, de Barros Wanderley MR Jr, et al. Carvedilol for Prevention of Chemotherapy-Related Cardiotoxicity: The CECCY Trial. J Am Coll Cardiol 2018;71:2281-90.
Editorial Comment: Asnani A. Beta-Blockers for Primary Prevention of Anthracycline Cardiotoxicity: Not Quite Ready for Prime Time. J Am Coll Cardiol 2018;71:2291-92.
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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