TY - JOUR
T1 - Activity of thalidomide in AIDS-related Kaposi's sarcoma
AU - Little, Richard F.
AU - Wyvill, Kathleen M.
AU - Pluda, James M.
AU - Welles, Lauri
AU - Marshall, Vickie
AU - Figg, William D.
AU - Newcomb, Fonda M.
AU - Tosato, Giovanna
AU - Feigal, Ellen
AU - Steinberg, Seth M.
AU - Whitby, Denise
AU - Goedert, James J.
AU - Yarchoan, Robert
PY - 2000/7
Y1 - 2000/7
N2 - Purpose: To assess the toxicity and activity of oral thalidomide in Kaposi's sarcoma (KS) in a phase II dose-escalation study. Patients and Methods: 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/mm3 (range, 14 to 646 cells/mm3) 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.
AB - Purpose: To assess the toxicity and activity of oral thalidomide in Kaposi's sarcoma (KS) in a phase II dose-escalation study. Patients and Methods: 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/mm3 (range, 14 to 646 cells/mm3) 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.
UR - http://www.scopus.com/inward/record.url?scp=0033916672&partnerID=8YFLogxK
U2 - 10.1200/JCO.2000.18.13.2593
DO - 10.1200/JCO.2000.18.13.2593
M3 - Article
AN - SCOPUS:0033916672
SN - 0732-183X
VL - 18
SP - 2593
EP - 2602
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 13
ER -