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Войти в исследования AIDS (London, England) · 1996
Randomized cross-over comparison of liposomal daunorubicin versus observation for early Kaposi's sarcoma.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Uthayakumar S, Bower M, Money-Kyrle J, Muyshondt C, Youle M, Hannon F, Phillips R, Gazzard B G, Boag F
Аннотация
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.
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.