Year: 2006
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: Cancer
DOI: 10.1002/cncr.22047
Authors: Alvaro Moreno‐Aspitia, Gerardo Colon‐Otero, Antje Hoering, Ayalew Tefferi, Robert D. Niedringhaus, Allen Vukov, Chin‐Yang Li, David M. Menke, Susan M. Geyer, Steven R. Alberts, For the North Central Cancer Treatment Group
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G358241105, ARIZONA MINORITY COMMUNITY CLINICAL ONCOLOGY PROGRAM, G42877212, G4735194841, Community Clinical Oncology Program, G6109875642, North Central Cancer Treatment Group, G688707633, Community Clinical Oncology Program, G844520391, Scottsdale Community Clinical Oncology Program, Mayo Clinic Comprehensive Cancer Center Support Grant
OpenAlex ID: W1980355836
