Randomized cross-over comparison of liposomal daunorubicin versus observation for early Kaposi's sarcoma.
AIDS
; 10(5): 515-9, 1996 May.
Article
en En
| MEDLINE
| ID: mdl-8724043
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 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 OUTCOMEMEASURES:
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Sarcoma de Kaposi
/
Daunorrubicina
/
Infecciones Oportunistas Relacionadas con el SIDA
/
Antibióticos Antineoplásicos
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
AIDS
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
1996
Tipo del documento:
Article
País de afiliación:
Reino Unido