Randomized cross-over comparison of liposomal daunorubicin versus observation for early Kaposi's sarcoma.
OBJECTIVE
To evaluate single-agent liposomal daunorubicin chemotherapy in the management of early HIV-related Kaposi's sarcoma (KS).


METHODS
Randomized cross-over comparison of liposomal daunorubicin versus observation.


METHODS
Study conducted at single site in tertiary referral HIV unit.


METHODS
Twenty-nine HIV-seropositive men with < 20 cutaneous KS, no visceral involvement and CD4 cell counts < 400 x 10(6)/I were randomized. Adequate haematological, hepatic and renal function was required for entry. A left ventricular ejection fraction of > 45% was necessary for eligibility.


METHODS
Patients were randomized to 12 weeks observation or 12 weeks of liposomal daunorubicin 40 mg/m2 every 2 weeks. After 12 weeks, or at disease progression, patients were crossed over to receive the alternative arm.


METHODS
Disease evaluation was according to AIDS Clinical Trials Group criteria for response assessment and toxicity was recorded using the World Health Organization standardized grading.


RESULTS
Response rate to initial liposomal daunorubicin was six out of 15 (40%) and none experienced a spontaneous response during the observation arm. Six patients (40%) randomized to the initial chemotherapy arm progressed during chemotherapy, while 10(72%) in the observation arm progressed. Neutropenia was the main toxicity associated with liposomal daunorubicin and was documented following 20 out of 139(14%) treatment cycles.


CONCLUSIONS
Liposomal daunorubicin is a well tolerated and efficacious treatment for early KS; however, the duration of response is brief.
Uthayakumar
S
S
Department of HIV and Genitourinary Medicine, Chelsea and Westminster Hospital, London, UK.
Bower
M
M
Money-Kyrle
J
J
Muyshondt
C
C
Youle
M
M
Hannon
F
F
Phillips
R
R
Gazzard
B G
BG
Boag
F
F
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D003630:Daunorubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004337:Drug Carriers; D006801:Humans; D008081:Liposomes; D008297:Male; D012514:Sarcoma, Kaposi / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; D004337:Drug Carriers; D008081:Liposomes; D003630:Daunorubicin