Cardiac safety profile of pegylated liposomal doxorubicin reaching or exceeding lifetime cumulative doses of 550 mg/m2in patients with recurrent ovarian and peritoneal cancer

Abstract

The objective of this study is to evaluate the cardiac safety of pegylated liposomal doxorubicin (PLD) reaching or exceeding a cumulative dose of 550 mg/m2in patients with recurrent ovarian and peritoneal cancer. A total of 14 patients (11 ovarian cancer, 3 primary peritoneal cancer) who received PLD in our center between February 2004 and October 2006 met inclusion criteria of the study. PLD was administered at doses of 30 mg/m2together with carboplatin or 50 mg/m2as a single agent every 3–6 weeks. Left ventricular ejection fraction (LVEF) estimations performed by M Mode ultrasound (General Electric Vivid-3, Milwaukee, Wisconsin) and clinical cardiac status were used to detect PLD-related cardiotoxicity. The median cumulative dose of PLD was 685.5 mg/m2(range 552–1015 mg/m2) and the median number of PLD courses was 9.5 (range 7–17). One patient had also been previously treated with conventional doxorubicin. LVEF scans were obtained on 10 of the 14 patients at the beginning of the therapy and on all patients at the end of therapy. No clinical evidence (symptoms or physical findings) of cardiac dysfunction had been observed in these patients either during active treatment or follow-up period. Despite small number of patients and lack of control group, our study suggests that the cumulative doses in excess of 550 mg/m2of PLD seem to not carry a significant risk of cardiomyopathy as judged by LVEF and clinical follow-up.