Stealth liposomal doxorubicin (SLD) delivers more doxorubicin (DOX) to AIDS-Kaposi's sarcoma (AIDS-KS) lesions than to normal skin (Meeting abstract).

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Stealth liposomal doxorubicin (SLD) delivers more doxorubicin (DOX) to AIDS-Kaposi's sarcoma (AIDS-KS) lesions than to normal skin (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 13:A5 1994. Unique Identifier : AIDSLINE ICDB/94600002
Northfelt DW; Univ. of California, San Francisco 94143-1270

Abstract: Objectives: (1) Compare DOX concentrations in paired biopsy specimens of AIDS-KS and normal skin following treatment with SLD; (2) Establish pharmacokinetic (PK) parameters for two dose levels of SLD; (3) Assess safety of SLD following single dose administration. Methods: 24 patients (pts) with biopsy-proven AIDS-KS were prospectively randomized to receive 10 or 20 mg/m2 of SLD in a single intravenous infusion. Plasma DOX concentrations were measured at intervals for 10 days after dosing. DOX concentrations were measured at paired biopsies of AIDS-KS lesions and normal skin 48 hr after dosing in 8 pts in each dose group, and 96 hr after dosing in remaining pts. Safety of SLD was evaluated in the 3 wk following treatment. Results are shown in a table. SLD has an acceptable safety profile in AIDS-KS pts, limited primarily by myelosuppression; detailed safety data are described. Conclusions: (1) SLD delivers approximately 10-20 times more DOX to AIDS-KS lesions than to normal skin; (2) Previous observations of prolonged plasma T1/2 beta and large AUC of SLD in AIDS-KS pts are confirmed; (3) SLD has an acceptable safety profile in AIDS-KS pts.

Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY/PATHOLOGY Biopsy Comparative Study Dose-Response Relationship, Drug Doxorubicin/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ PHARMACOKINETICS Drug Carriers Human Infusions, Intravenous Liposomes Prospective Studies Sarcoma, Kaposi's/*DRUG THERAPY/PATHOLOGY Skin/PATHOLOGY Skin Neoplasms/*DRUG THERAPY/PATHOLOGY ABSTRACT RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL
940830
M9480792

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