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Prepublished online as a Blood First Edition Paper on November 27, 2002; DOI 10.1182/blood-2002-09-2928. This Article Full Text Full Text (PDF) All Versions of this Article: 2002-09-2928v1 101/7/2534    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Mesa, R. A. Articles by Tefferi, A. Search for Related Content PubMed PubMed Citation Articles by Mesa, R. A. Articles by Tefferi, A. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 1 April 2003, Vol. 101, No. 7, pp. 2534-2541 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS A phase 2 trial of combination low-dose thalidomide and prednisone for the treatment of myelofibrosis with myeloid metaplasia Ruben A. Mesa, David P. Steensma, Animesh Pardanani, Chin-Yang Li, Michelle Elliott, Scott H. Kaufmann, Gregory Wiseman, Leigh A. Gray, Georgene Schroeder, Terra Reeder, Jerome B. Zeldis, and Ayalew Tefferi From the Division of Hematology and Internal Medicine, Cancer Center Statistics Unit, Division of Hematopathology, and Division of Nuclear Medicine, Mayo Clinic, Rochester, MN; and Celgene, Warren, NJ. Single-agent thalidomide (THAL) at "conventional" doses (> 100 mg/d) has been evaluated in myelofibrosis with myeloid metaplasia (MMM) based on its antiangiogenic properties and the prominent neoangiogenesis that occurs in MMM. THAL monotherapy at such doses produces approximately a 20% response rate in anemia but is poorly tolerated (an adverse dropout rate of > 50% in 3 months). To improve efficacy and tolerability, we prospectively treated 21 symptomatic patients (hemoglobin level < 10 g/dL or symptomatic splenomegaly) with MMM with low-dose THAL (50 mg/d) along with a 3-month oral prednisone (PRED) taper (beginning at 0.5 mg/kg/d). THAL-PRED was well tolerated in all enrolled patients, with 20 patients (95%) able to complete 3 months of treatment. An objective clinical response was demonstrated in 13 (62%) patients, all improvements in anemia. Among 10 patients who were dependent on erythrocyte transfusions, 7 (70%) improved and 4 (40%) became transfusion independent. Among 8 patients with thrombocytopenia (platelet count < 100 × 109/L), 6 (75%) experienced a 50% or higher increase in their platelet count. In 4 of 21 patients (19%), spleen size decreased by more than 50%. Responses observed were mostly durable after discontinuation of the PRED. The dose of THAL in this study (50 mg/d) was better tolerated than the higher doses used in previous studies. Adverse events associated with corticosteroid therapy were mild and transient. Clinical responses did not correlate with improvements in either intramedullary fibrosis or angiogenesis. THAL-PRED is well tolerated and preliminarily appears to be a promising drug regimen for treating cytopenias in patients with MMM. © 2003 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: R. A. 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Tefferi Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Etanercept ("PET regimen") in the Treatment of Anemia, Splenomegaly, and Constitutional Symptoms Associated with Myelofibrosis with Myeloid Metaplasia (MMM). Blood (ASH Annual Meeting Abstracts), November 16, 2004; 104(11): 1520 - 1520. [Abstract] V. Eleutherakis-Papaiakovou, A. Bamias, and M. A. Dimopoulos Thalidomide in cancer medicine Ann. Onc., August 1, 2004; 15(8): 1151 - 1160. [Abstract] [Full Text] [PDF] R. T. Silver Myelofibrosis: Thalidomide Finds a New Disease Mayo Clin. Proc., July 1, 2004; 79(7): 857 - 858. [PDF] R. A. Mesa, M. A. Elliott, G. Schroeder, and A. Tefferi Durable Responses to Thalidomide-Based Drug Therapy for Myelofibrosis With Myeloid Metaplasia Mayo Clin. Proc., July 1, 2004; 79(7): 883 - 889. [Abstract] [PDF] S. V. Rajkumar Thalidomide: Tragic Past and Promising Future Mayo Clin. Proc., July 1, 2004; 79(7): 899 - 903. [PDF] S. Kumar, T. E. Witzig, and S. V. 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