Doxorubicin (DOX)-induced cardiotoxicity can limit the duration of therapy with this agent and may be exacerbated by combination with newer agents such as taxanes. DOXIL, a pegylated liposome formulation of doxorubicin, is less cardiotoxic than DOX in rats, dogs and rabbits. This study compares biopsy scores in a group of AIDS Kaposi's sarcoma (KS) patients (pts) receiving DOXIL with those from a historical control group of cancer pts treated with DOX. Biopsy score in both groups is expressed as the 6-point scale (0-3.0) previously described (Cancer Treat Symp; 3:71 1984). Ten KS pts who had received cumulative doses ranging from 400 to greater than 700 mg/m2 of DOX as DOXIL were entered. Matched controls were retrospectively identified from a data base of 131 cardiac biopsy pts who had participated in clinical trials of DOX at Stanford University between 1974-1982 (F Torti and B Lum). The closest match with respect to cumulative dose of doxorubicin was selected. Matched controls were +/- 10 mg/m2 for 8/10 DOXIL patients. Good matches were not available form the data base for 2 DOXIL patients who had received doses of 780 and 860 mg/m2 (the highest dose in the control group was 671 mg/m2), however, both these pts had scores of 0.5 indicating no DOX-specific toxicity. In an unblinded comparison of the 8 DOXIL pts with their matched controls, DOXIL pts had a lower median pathology score (0.5 for DOXIL vs 2.25 for DOX) and the difference between the groups was highly significant (paired t-test, p less than 0.001). These data suggest that DOXIL is less cardiotoxic than DOX at comparable cumulative doses. Blinded, randomized readings of the control and DOXIL groups are being conducted to reduce possible biases. Additional statistical tests comparing the two groups based on these blinded readings will be presented.

Acquired Immunodeficiency Syndrome/*COMPLICATIONS Antibiotics, Anthracycline/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Dose-Response Relationship, Drug Doxorubicin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Drug Carriers Human Liposomes Sarcoma, Kaposi's/COMPLICATIONS/*DRUG THERAPY ABSTRACT

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