AIDS-related Kaposi's sarcoma: a phase II study of liposomal doxorubicin. The TLC D-99 Study Group.
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.
Cheung
T W
TW
Division of Neoplastic Diseases and Infectious Diseases, Mount Sinai School of Medicine, New York, New York 10029, USA.
Remick
S C
SC
Azarnia
N
N
Proper
J A
JA
Barrueco
J R
JR
Dezube
B J
BJ
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications* / Q000276:immunology; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002784:Cholesterol; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004337:Drug Carriers; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010713:Phosphatidylcholines; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000209:etiology; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors
D000970:Antineoplastic Agents; D004337:Drug Carriers; D008081:Liposomes; D010713:Phosphatidylcholines; D004317:Doxorubicin; D002784:Cholesterol