RANDOMIZED CROSS-OVER COMPARISON OF LIPOSOMAL DAUNORUBICIN VERSUS OBSERVATION FOR EARLY KAPOSIS-SARCOMA

Objectives: To evaluate single-agent liposomal daunorubicin chemothera py in the management of early HIV-related Kaposi's sarcoma (KS). Desig n: Randomized cross-over comparison of liposomal daunorubicin versus o bservation. Setting: Study conducted at single site in tertiary referr al HIV unit. Patients: Twenty-nine HIV-seropositive men with < 20 cuta neous KS, no visceral involvement and CD4 cell counts < 400x10(6)/l we re 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/m(2) every 2 weeks. After 12 weeks, or at disease progression, patients we re crossed over to receive the alternative arm. Main outcome measures: Disease evaluation was according to AIDS Clinical Trials Group criter ia for response assessment and toxicity was recorded using the World H ealth Organization standardized grading. Results: Response rate to ini tial liposomal daunorubicin was six out of 15 (40%) and none experienc ed a spontaneous response during the observation arm. Six patients (40 %) randomized to the initial chemotherapy arm progressed during chemot herapy, while 10 (72%) in the observation arm progressed. Neutropenia was the main toxicity associated with liposomal daunorubicin and was d ocumented 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.