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Thalidomide therapy in adult patients with myelodysplastic syndrome
A North Central Cancer Treatment Group phase II trial†
Version of Record online: 6 JUL 2006
Copyright © 2006 American Cancer Society
Volume 107, Issue 4, pages 767–772, 15 August 2006
How to Cite
Moreno-Aspitia, A., Colon-Otero, G., Hoering, A., Tefferi, A., Niedringhaus, R. D., Vukov, A., Li, C.-Y., Menke, D. M., Geyer, S. M., Alberts, S. R. and For the North Central Cancer Treatment Group (2006), Thalidomide therapy in adult patients with myelodysplastic syndrome. Cancer, 107: 767–772. doi: 10.1002/cncr.22047
Presented at the annual meeting of the American Society of Hematology, Philadelphia, Pennsylvania, December 6–10, 2002.
- Issue online: 10 AUG 2006
- Version of Record online: 6 JUL 2006
- Manuscript Accepted: 10 APR 2006
- Manuscript Revised: 23 FEB 2006
- Manuscript Received: 22 NOV 2005
- National Cancer Institute Department of Health and Human Services. Grant Numbers: CA-25224, CA-37404, CA-15083, CA-63826, CA-35431, CA-60276
- clinical trials;
- hematologic diseases;
- International Prognostic Scoring System;
- myelodysplastic syndromes;
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.
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.
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%).
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. Cancer 2006. © 2006 American Cancer Society.