Randomized cross-over comparison of liposomal daunorubicin versus observation for early Kaposi's sarcoma.

OBJECTIVES

To evaluate single-agent liposomal daunorubicin chemotherapy in the management of early HIV-related Kaposi's sarcoma (KS).

DESIGN

Randomized cross-over comparison of liposomal daunorubicin versus observation.

SETTING

Study conducted at single site in tertiary referral HIV unit.

PATIENTS

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.

INTERVENTIONS

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.

MAIN OUTCOME MEASURES

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.