Cardiac Data
Please see Boxed WARNINGS for Cardiac Toxicity and Additional Safety Information below.
From a Large Single-Agent Phase III Clinical Study of Patients With Recurrent Epithelial Ovarian Cancer That Evaluated the Efficacy and Safety of DOXIL® and Topotecan1
Safety Evaluations
Selection criteria1
- Eligibility criteria included left ventricular ejection fraction (LVEF) ≥50%
- Patients were excluded if they had a history of cardiac disease meeting New York Heart Association Classification ≥2
Cardiac clinical assessments1
- LVEF was assessed by a multiple-gated acquisition (MUGA) scan at baseline and at end of study for all patients
Protocol-specified LVEF criteria for cardiac toxicity1
- Treatment with either study drug temporarily suspended or discontinued in patients with LVEF to a value of <45% or an absolute decrease of 20% compared with the baseline value
Summary of Baseline Patient Characterisitics1
LVEF changes from baseline
- For those DOXIL®-treated patients who received a baseline and ≥1 postdose LVEF evaluation (n=132), the mean absolute change from baseline to last LVEF measurement was -2.7%2
- None of these patients had clinical signs or symptoms of congestive heart failure
- Median cumulative dose of DOXIL® was 200 mg/m2 (range, 47.3 to 1400.6 mg/m2)2
- 62 patients received cumulative DOXIL® doses ≥300 mg/m2, and 17 of those exceeded 450 mg/m2
- There was no evidence of a direct relationship beween a change from baseline LVEF and cumulative DOXIL® dose ≥300 mg/m2
DOXIL®-Treated Patients Who Experienced a Drug-Related Cardiac Adverse Reaction*2
- 3.8% of DOXIL®-treated patients (n=239) experienced a drug-related cardiovascular event2
*One patient death due to cardiac arrest of unknown relationship.
†These patients were discontinued from the trial.
