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Study Shows That Doxil is Highly Effective and Safe in the Treatment of Advanced Kaposi's Sarcoma

Date: May 20, 1997
Source: National Institutes of Health (NIH)
Author: National Institute of Allergy and Infectious Diseases (NIAID)

According to UCLA AIDS researchers, DOXIL, a formulation of pegylated liposomal doxorubicin HCl, has been shown to be an effective initial treatment for advanced AIDS-related Kaposi's sarcoma (KS), based on data from a study presented today at the 33rd Annual Meeting of the American Society of Clinical Oncology in Denver.

Kaposi's sarcoma is the most common malignancy associated with HIV-infection and is often characterized by purplish or brown lesions on the skin. In more advanced stages of the disease, lymphedema is common, and many patients have life-threatening visceral disease of the lungs.

The study was designed to evaluate how KS tumors responded and how well patients tolerated the addition of other chemotherapy drugs to DOXIL, according to Dr. Ronald Mitsuyasu, director of the UCLA Center for Clinical AIDS Research and Education (CARE) and associate director of the UCLA AIDS Institute. Mitsuyasu presented clinical data as a representative of the AIDS Clinical Trial Group (ACTG) that performed the Phase III study, which compared DOXIL alone to Doxil in combination with bleomycin and vincristine (DBV) in advanced stage AIDS-KS patients who had not received prior chemotherapy.

Our trial yielded results showing that the addition of DBV to DOXIL may increase toxicity and decrease quality of life without substantially improving clinical outcomes," said Mitsuyasu. "This indicates that giving DOXIL alone is a highly effective and safe treatment for patients with advanced AIDS-KS."

The study included 126 patients with similar baseline characteristics; 62 were given DOXIL and 64 were given the combination therapy. Patients with multiple mucocutaneous lesions and/or visceral KS and/or symptomatic oral lesions, or those with CD4 counts less than or equal to 100 and with 10 or more lesions, were randomized to receive DOXIL with or without bleomycin and vincristine every two weeks. Toxicity was assessed every two weeks, and tumor response using ACTG criteria was assessed every four weeks.

On average, patients on DOXIL alone reached a high toxicity level after 10 weeks, while patients on the combination therapy reached a toxic level after just seven weeks. More patients discontinued treatment for toxicities from the combination therapy than on DOXIL alone; 16 versus four.

The overall tumor responses were similar for both groups as were average times of tumor progression or death; 29 weeks on DOXIL and 32 weeks on DVB. A scheduled interim analysis showed a trend toward better survival for DOXIL versus DVB; 11 versus 18 deaths. Additionally, UCLA researchers indicated that quality-of-life scales decreased more rapidly during treatment with DBV than with DOXIL alone, and all DBV patients were subsequently switched to DOXIL alone.

Collaborating on the study with Mitsuyasu were investigators from 18 other ACTG centers, the National Institute of Allergy and Infectious Diseases, Division of AIDS Statistical and Data Management Center at Harvard University.

The study was funded by the National Institutes of Allergy and Infectious Diseases, AIDS Clinical Trials Group.

The UCLA AIDS Institute was established in 1992 to help organize all HIV-related research, clinical activities and education programs at UCLA and affiliated teaching hospitals. The institute encourages interdisciplinary research projects and fosters the highest-quality research into all aspects of AIDS and HIV disease. The UCLA CARE Center was established in 1983 to facilitate clinical research projects and to integrate current research findings with teaching and patient care.