Activity of thalidomide in AIDS-related Kaposi's sarcoma.
J Clin Oncol
; 18(13): 2593-602, 2000 Jul.
Article
em En
| MEDLINE
| ID: mdl-10893291
ABSTRACT
PURPOSE:
To assess the toxicity and activity of oral thalidomide in Kaposi's sarcoma (KS) in a phase II dose-escalation study. PATIENTS ANDMETHODS:
Human immunodeficiency virus (HIV)-seropositive patients with biopsy-confirmed KS that progressed over the 2 months before enrollment received an initial dose of 200 mg/d of oral thalidomide in a phase II study. The dose was increased to a maximum of 1,000 mg/d for up to 1 year. Anti-HIV therapy was maintained during the study period. Toxicity, tumor response, immunologic and angiogenic factors, and virologic parameters were assessed.RESULTS:
Twenty patients aged 29 to 49 years with a median CD4 count of 246 cells/mm(3) (range, 14 to 646 cells/mm(3)) were enrolled. All patients were assessable for toxicity, and 17 for response. Drowsiness in nine and depression in seven patients were the most frequent toxicities observed. Eight (47%; 95% confidence interval [CI], 23% to 72%) of the 17 assessable patients achieved a partial response, and an additional two patients had stable disease. Based on all 20 patients treated, the response rate was 40% (95% CI, 19% to 64%). The median thalidomide dose at the time of response was 500 mg/d (range, 400 to 1,000 mg/d). The median duration of drug treatment was 6.3 months, and the median time to progression was 7.3 months.CONCLUSION:
Oral thalidomide was tolerated in this population at doses up to 1,000 mg/d for as long as 12 months and was found to induce clinically meaningful anti-KS responses in a sizable subset of the patients. Additional studies of this agent in KS are warranted.
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Base de dados:
MEDLINE
Assunto principal:
Sarcoma de Kaposi
/
Talidomida
/
Síndrome da Imunodeficiência Adquirida
/
Fármacos Anti-HIV
Limite:
Adult
/
Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2000
Tipo de documento:
Article