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
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
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