TY - JOUR
T1 - Thalidomide therapy in adult patients with myelodysplastic syndrome
T2 - A North Central Cancer Treatment Group Phase II trial
AU - Moreno-Aspitia, Alvaro
AU - Colon-Otero, Gerardo
AU - Hoering, Antje
AU - Tefferi, Ayalew
AU - Niedringhaus, Robert D.
AU - Vukov, Allen
AU - Li, Chin Yang
AU - Menke, David M.
AU - Geyer, Susan M.
AU - Alberts, Steven R.
PY - 2006/8/15
Y1 - 2006/8/15
N2 - BACKGROUND. Thalidomide has shown promise for the treatment of patients with myelodysplastic syndrome. The current prospective multicenter study examined the efficacy and toxicity of thalidomide in adult patients with myelodysplastic syndrome. METHODS. Using the International Prognostic Scoring System (IPSS), patients were stratified into 2 groups: favorable (IPSS score, 0-1.0) or unfavorable (IPSS score, 1.5-3.5). Seventy-two patients (42 of whom were favorable and 30 of whom were unfavorable) received a starting dose of oral thalidomide of 200 mg daily. The dose was increased by 50 mg per week to a targeted maximum daily dose of 1000 mg. RESULTS. According to the International Working Group response criteria for myelodysplastic syndrome, 1 patient in the unfavorable group achieved a partial remission with a complete cytogenetic response. Overall, 2 patients (5%) in the favorable group and 4 patients (14%) in the unfavorable group experienced either a hematologic improvement or a partial response. The most frequent Grade 3 or 4 (grading was based on the National Cancer Institute's Common Toxicity Criteria [version 2.0]) nonhematologic adverse events were fatigue (24%), infection (19%), neuropathy (13%), dyspnea (8%), and constipation (7%). CONCLUSIONS. Thalidomide alone, at the schedule and dose levels used in the current study, is not a safe and viable therapeutic option for patients with myelodysplastic syndrome. Limited efficacy and increased toxicity were observed in the current Phase II trial.
AB - BACKGROUND. Thalidomide has shown promise for the treatment of patients with myelodysplastic syndrome. The current prospective multicenter study examined the efficacy and toxicity of thalidomide in adult patients with myelodysplastic syndrome. METHODS. Using the International Prognostic Scoring System (IPSS), patients were stratified into 2 groups: favorable (IPSS score, 0-1.0) or unfavorable (IPSS score, 1.5-3.5). Seventy-two patients (42 of whom were favorable and 30 of whom were unfavorable) received a starting dose of oral thalidomide of 200 mg daily. The dose was increased by 50 mg per week to a targeted maximum daily dose of 1000 mg. RESULTS. According to the International Working Group response criteria for myelodysplastic syndrome, 1 patient in the unfavorable group achieved a partial remission with a complete cytogenetic response. Overall, 2 patients (5%) in the favorable group and 4 patients (14%) in the unfavorable group experienced either a hematologic improvement or a partial response. The most frequent Grade 3 or 4 (grading was based on the National Cancer Institute's Common Toxicity Criteria [version 2.0]) nonhematologic adverse events were fatigue (24%), infection (19%), neuropathy (13%), dyspnea (8%), and constipation (7%). CONCLUSIONS. Thalidomide alone, at the schedule and dose levels used in the current study, is not a safe and viable therapeutic option for patients with myelodysplastic syndrome. Limited efficacy and increased toxicity were observed in the current Phase II trial.
KW - Clinical trials
KW - Hematologic diseases
KW - International Prognostic Scoring System
KW - Leukemia
KW - Myelodysplastic syndromes
KW - Thalidomide
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U2 - 10.1002/cncr.22047
DO - 10.1002/cncr.22047
M3 - Article
C2 - 16826578
AN - SCOPUS:33747185088
SN - 0008-543X
VL - 107
SP - 767
EP - 772
JO - Cancer
JF - Cancer
IS - 4
ER -