Proc Annu Meet Am Soc Clin Oncol; 15:A843 1996. Unique Identifier :
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