NEW YORK (Reuters Health) Aug 27 - Compared with docetaxel alone, the combination of pegylated liposomal doxorubicin (Doxil, Ortho Biotech) and docetaxel significantly prolongs time to disease progression in certain women with advanced breast cancer, a study indicates.
Dr. Joseph A. Sparano of Montefiore-Einstein Cancer Center, The Bronx, New York, and colleagues studied 751 women who had experienced relapse at least 1 year after previous adjuvant or neoadjuvant anthracycline therapy.
The women were randomized to receive either docetaxel (75 mg/m�) monotherapy or liposomal doxorubicin (30 mg/m�) followed by docetaxel (60 mg/m�) every 21 days. Therapy was continued until disease progression or prohibitive toxicity.
In a report posted online August 17th in the Journal of Clinical Oncology, the researchers report that the combination therapy prompted a significant improvement in median time to progression from 7.0 months to 9.8 months. The objective response rate rose from 26% to 35%.
Hand-foot syndrome was seen in 24% of patients the combination group and none of the patients in the monotherapy group. Twelve percent of the combination group experienced mucositis/stomatitis compared to 1% of monotherapy patients.
Nevertheless, the overall incidence of adverse events was similar in both groups, as was the incidence of protocol-defined decreases in left ventricular ejection fraction and congestive heart failure.
The Doxil-docetaxel combination, Dr. Sparano told Reuters Health, "essentially adds a new treatment option for patients with advanced breast cancer who have already received anthracyclines for early stage disease, a situation in which anthracyclines like Doxil would not have been previously used or even considered because of safety concerns."
J Clin Oncol 2009.
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