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New Data Indicate DOXIL Is Appropriate First-Line Therapy for Kaposi's Sarcoma WASHINGTON--Jan. 24, 1997-- DOXIL(R) vs. ABV, BV Efficacy and Safety Data To Be Presented at Conference on Retroviruses and Opportunistic Infections -- DOXIL(R) is indicated for first-line treatment for Kaposi's sarcoma (KS) and is suitable for long-term therapy, based on integrated efficacy and safety data from two studies to be presented tomorrow at the 4th Conference on Retroviruses and Opportunistic Infections. DOXIL is a formulation of doxorubicin hydrochloride encapsulated in polyethylene glycol-coated liposomes. Dr. Donald Northfelt of Pacific Oaks Medical Group, and the University of California, San Diego, served as co-principal investigator in the two trials, which compared the activity of DOXIL to combinations of Adriamycin (doxorubicin)-bleomycin-vincristine (ABV) and to bleomycin-vincristine (BV). A total of 254 patients were treated with DOXIL, 125 with ABV and 120 with BV. Two dosing intervals were included in the protocol: two weeks in the DOXIL vs. ABV study and 3 weeks in the DOXIL vs. BV study. "The data clearly indicate that single agent DOXIL is an important first-line, long-term treatment option," said Dr. Northfelt. "DOXIL has a superior tumor response rate relative to both ABV and BV, a superior safety profile to ABV and an equivalent safety profile to BV, but without the common dose-limiting toxicities associated with BV." The trials yielded a response of 52% in the combined DOXIL group, 25% in the ABV group and 23% among BV patients. A greater number of DOXIL patients were able to complete the trials (68% for DOXIL vs. 34% for ABV and 55% for DOXIL vs. 31% for BV). Fewer and less severe adverse events, including nausea/vomiting, alopecia, peripheral sensory neuropathy and neutropenia (<1000 cells/mm3), were reported in the DOXIL arm relative to ABV, with the exception of mucositis, which was more frequent among DOXIL patients. Less than 1% of all patients reported skin toxicity. As compared to BV, Dr. Northfelt reported a greater degree of neutropenia in DOXIL patients, but less peripheral neuropathy and nausea/vomiting. The rates of opportunistic infections were similar among DOXIL, ABV and BV patients. E-mail this page to a friend or colleague! To print, use this version