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- W1999651010 abstract "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 < 400×106/l 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." @default.
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- W1999651010 date "1996-05-01" @default.
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- W1999651010 title "Randomized cross-over comparison of liposomal daunorubicin versus observation for early Kaposiʼs sarcoma" @default.
- W1999651010 doi "https://doi.org/10.1097/00002030-199605000-00010" @default.
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