Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment (HEART)

• Left ventricular thickness-to-dimension ratio assessed using standard 2-dimensional. [ Time Frame: Baseline ]
  Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
  
  
• Left ventricular thickness-to-dimension ratio assessed using M-mode. [ Time Frame: Baseline ]
  Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
  
  
• Left ventricular thickness-to-dimension ratio assessed using Doppler echocardiogram. [ Time Frame: Baseline ]
  Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
  
  

• Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) [ Time Frame: Baseline ]
  
• Primary disease relapse [ Time Frame: Baseline ]
  An analytic Markov model will be created and used.
  
  
• Quality of life based on self-report instruments [ Time Frame: Baseline ]
  An analytic Markov model will be created and used. Estimates and their 95% confidence will be included to explore the sensitivity of any QALY estimates.
  
  
• Second cancer rates [ Time Frame: Baseline ]
  An analytic Markov model will be created and used.
  
  

PRIMARY OBJECTIVES:

I. To determine whether patients randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm.

II. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex).

SECONDARY OBJECTIVES:

I. To determine whether patients on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms.

II. To determine whether projected quality-adjusted life years (QALY) differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

OUTLINE:

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.