Liposome vs Standard Doxorubicin

Results of a phase III trial show that liposome-encapsulated doxorubicin (Myocet, Elan Corp.) is as effective as the drug's standard formulation, and far less cardiotoxic.

Dr. Gerald Batist, of Jewish General Hospital in Montreal, and associates randomized 142 patients with metastatic breast cancer to receive Myocet and 155 to receive conventional doxorubicin, both at 60 mg/meter squared. Subjects in both groups were treated with cyclophosphamide 600 mg/meter squared. Treatment was administered every 3 weeks "until disease progression or unacceptable toxicity" occurred.

Either complete or partial response was observed in 43% of patients in both treatment groups, the research team reports in the Journal of Clinical Oncology for March 1. Duration of response, disease progression or death, and time to progression were similar in the two groups. Median survival was 19 months in those treated with the Myocet and 16 months for the conventional doxorubicin group.

Protocol-defined cardiotoxicity developed in 6% of the liposome-encapsulated doxorubicin group and 21% of the control group. The estimated median cumulative lifetime dose of doxorubicin at the first appearance of cardiac toxicity was >2220 mg/meter squared and 480 mg/meter squared in the two groups, respectively. Patients treated with the new preparation were 80% less likely to develop cardiotoxicity than their counterparts.

The investigators observed no new or unexpected adverse events in those treated with the new preparation, nor was there an increase in incidence or severity of known doxorubicin-related adverse effects. Grade 4 neutropenia occurred in 61% of the Myocet group versus 75% in the other group. The investigators also noted a significant reduction in mucositis/stomatitis incidence in the Myocet group.

An advantage of the new therapy, according to the authors, is that patients who relapse after treatment for early breast cancer can potentially be retreated with Myocet, which is not possible with the older product because of its cardiotoxicity.

J Clin Oncol 2001;19:1444-1454.

Thanks to Reuters Health

Early Cardiac Damage from Epirubicin

JCO, May 2001

Cardiovascular Trials:Long-term Childhood Survivors

J Clin Onc, 3/04

References for Editorial on Cardiotox Children
Skin Toxicity with Liposomal Doxorubicin

Abstract # 5080 ASCO, 2004

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