Monitoring long-term treatment with pegylated liposomal doxorubicin: how important is intensive cardiac follow-up?

Pegylated liposomal doxorubicin (PLD; Doxil or Caelyx) has been shown to be as effective as conventional doxorubicin, and to have a significantly better cardiac safety profile. The aim of this study was to assess the safety of delivering doses exceeding 700 mg/m of PLD to patients with solid tumors. A review of the medical records of 149 patients with a variety of solid tumors treated with PLD was performed. The findings in 12 patients who had reached or exceeded cumulative doses of 700 mg/m (median=1.071 mg/m, range 712-1856 mg/m) were reviewed. Changes in left ventricular ejection fraction (LVEF), and in clinical cardiac status were analyzed. The median age of the patients was 53.9 years and the median follow-up from the start of PLD treatment was 44.6 months. None of the 12 patients had clinical congestive heart failure secondary to cardiomyopathy. Seven of the 12 patients underwent further assessment of LVEF by echocardiography or multiple gated acquisition scan, which revealed a stable or improved ejection fraction.PLD is cardiac safe for long-term treatment of metastatic solid tumors. Its maximal cumulative dose remains undefined. Frequent determinations of LVEF, as routinely done for other anthracyclines, do not appear to have any clinical value in patient follow-up. In metastatic patients with no evidence of cardiac risk factors, it may be sufficient to measure LVEF at baseline.