Phase IV study of liposomal daunorubicin (DaunoXome) in AIDS-related Kaposi sarcoma.

The purpose of this article was to study the efficacy and tolerance of liposomal daunorubicin (DaunoXome) in the treatment of AIDS-associated Kaposi sarcoma (KS) as prescribed in France between September 1996 and September 1997. All patients with a positive HIV serology, histologically proven KS, and having received at least one daunorubicin treatment cycle during the study period were eligible for entry. Ninety-four patient files from 13 university hospital departments were retrospectively studied. Of 94 patients, 80% received cytostatic treatment before the first daunorubicin treatment cycle. Initial mean CD4 lymphocyte count was 114/microl. Ninety percent of the patients received highly active antiretroviral treatment (HAART) during daunorubicin treatment. Daunorubicin was administered as single chemotherapy to 70% of the patients. The total number of treatment cycles was 1,422, with a mean number of 16.1 treatment cycles (1-68) per patient and a mean cumulative daunorubicin dose of 674 mg/m2 (40-2,749). According to the AIDS Clinical Trial Group criteria, partial and complete response rates were 26.5% and 11.5%, respectively. A hematopoietic growth factor was prescribed in 29% of the treatment cycles. At the final evaluation, 71% of the patients were alive. No severe cardiotoxic event was observed despite high cumulative drug doses and prolonged follow-up. Since the introduction of HAART, this study constitutes the only evaluation of daunorubicin in a wide population. Our study confirms that daunorubicin is effective in patients with advanced KS. Daunorubicin is well tolerated over the long term in association with HAART.