Key result
High cumulative pegylated liposomal doxorubicin shows 0% incidence of clinical CHF in gynecologic malignancies.
Why the study?
Does pegylated liposomal doxorubicin at cumulative doses ≥400 mg/m² cause cardiac toxicity in women with gynecologic malignancies?
Observational (n=42)
No
Does pegylated liposomal doxorubicin at cumulative doses ≥400 mg/m² cause cardiac toxicity in women with gynecologic malignancies?
High cumulative doses of pegylated liposomal doxorubicin (≥400 mg/m²) appear safe and are not associated with clinically evident cardiac toxicity in women with gynecologic malignancies.
May support higher cumulative dosing without evident HF in gynecologic cancers; hypothesis-generating, requires prospective confirmation.
PURPOSE: The purpose of this study was to determine the cardiac safety of pegylated liposomal doxorubicin (PLD) in patients receiving high cumulative doses of PLD. MATERIALS AND METHODS: A retrospective chart review of women with gynecologic malignancies treated at Roswell Park Cancer Institute from 2002 through 2007 who received cumulative doses of PLD >or=400 mg/m(2) was performed. RESULTS: Forty-two of 116 patients met the inclusion criteria. The mean age at initiation of PLD therapy was 63 years. The mean cumulative dose of PLD was 663.9 mg/m(2) (range 400-1,524 mg/m(2)). The mean cumulative number of cycles of PLD given was 9.8 (range 5-25). Multigated acquisition (MUGA) scans were obtained in 93% (39/42) of patients prior to or immediately following their first dose of PLD. The mean baseline ejection fraction was 63% (range 49-76%). Follow-up MUGA scans were performed on 7 patients (17%). Two of these patients had a decrease in their ejection fraction, but of only 3 and 1%. The remaining 5 patients who had follow-up MUGA scans had an average increase in their left ventricular ejection fraction of 4% (range 1-9%). No patients developed clinical evidence of congestive heart failure while being treated with PLD. There were no treatment interruptions or discontinuations due to cardiac toxicity. CONCLUSION: Cumulative doses of PLD >or=400 mg/m(2) are not associated with clinically evident cardiac toxicity in gynecologic oncology patients.
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Kesterson et al. (2010) conducted an observational in Gynecologic malignancies (n=42). Pegylated liposomal doxorubicin (PLD) was evaluated on Clinical evidence of congestive heart failure. High cumulative doses of pegylated liposomal doxorubicin (≥400 mg/m2) were not associated with clinically evident congestive heart failure (0% incidence) in women with gynecologic malignancies.
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