Carvedilol Effect in Preventing Chemotherapy Induced CardiotoxicitY - CECCY

May 15, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Date Presented:
03/11/2018
Date Published:
05/14/2018
Date Updated:
05/15/2018
Original Posted Date:
03/11/2018
References

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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