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AIDS-related Kaposi’s Sarcoma: A Phase II Study of Liposomal Doxorubicin¹

Division of Neoplastic Diseases and Infectious Diseases, Mount Sinai School of Medicine, New York, New York 10029 [T. W. C.]; Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 [B. J. D., J. A. P.]; Division of Hematology/Oncology, Albany Medical College, Albany, New York 12208 [S. C. R.]; Liposome Company Inc., Princeton, New Jersey 08540 [N. A.]; and Central Research, Pfizer Inc., New York, New York 10017 [J. R. B.]

TLC D-99 is a unique liposomal formulation of doxorubicin that consists of phosphatidyl choline/cholesterol. The objectives of the study were to evaluate safety and efficacy of two doses of TLC D-99 in the treatment of patients with AIDS-related Kaposi’s Sarcoma (KS). Forty HIV-infected persons with biopsy-proven KS were randomized to receive TLC D-99 at doses of either 10 (low) or 20 (high) mg/m² every 2 weeks. Patients assigned to the low-dose arm could be escalated to the high-dose arm if their KS progressed after 3 cycles of therapy. Median age was 35 years (range, 26–47) and median CD4 count was 13 (range, 0–440). Nineteen patients were assigned to receive the low dose, and 21 patients were assigned to the high dose. Partial response occurred in 15% (6 of 40) of the patients or in 5% (1 of 19) and 24% (5 of 21) in the low- and high-dose arms, respectively; stable disease was observed in 65% (26 of 40) or in 68% (13 of 19) and 62% (13 of 21) in the low and high doses, respectively. Neutropenia was the major toxicity and was observed in 68 and 81% of patients with the low- and high-dose arms, respectively; grade 4 neutropenia was observed in 16 and 14%, respectively. Mild alopecia was noted in only 8%. Therefore, TLC D-99 is active against AIDS-related KS, and the response is dose-dependent.

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