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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 (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 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. Social Bookmarking                   What's this? Submitted October 1, 2002 Accepted November 19, 2002 A phase II trial of combination low-dose thalidomide and prednisone for the treatment of myelofibrosis with myeloid metaplasia Ruben A Mesa, David P Steensma, Animesh Pardenani, Chin-Yang Li, Michelle A Elliott, Scott H Kaufmann, Gregory Wiseman, Leigh A Gray, Georgene Schroeder, Terra Reeder, Jerome Zeldis, and Ayalew Tefferi* Hematology, Mayo Clinic, Rochester, MN, USA Hematopathology, Mayo Clinic, Rochester, MN, USA Nuclear Medicine, Mayo Clinic, Rochester, MN, USA Cancer Center Statistics, Mayo Clinic, Rochester, MN, USA Celgene Corporation, Warren, NJ, USA * Corresponding author; email: tefferi.ayalew{at}mayo.edu. Single agent thalidomide (THAL) at "conventional" doses (>100 mg /day) has been evaluated in myelofibrosis with myeloid metaplasia (MMM) based on its anti-angiogenic properties and the prominent neo-angiogenesis 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). In order to improve efficacy and tolerability, we prospectively treated 21 symptomatic (hemoglobin <10 g/dL or symptomatic splenomegaly) MMM patients with low-dose THAL (50 mg/day) along with a three-month oral prednisone (PRED) taper (beginning at 0.5 mg/kg/day). THAL-PRED was well tolerated in all enrolled patients, with 20 patients (95%) able to complete three months of treatment. An objective clinical response was demonstrated in 13 (62%) patients, all improvements in anemia. Among 10 patients who were erythrocyte transfusion dependent, 7 (70%) improved and 4 (40%) became transfusion independent. Among 8 patients with thrombocytopenia (platelet count <100 x 109/L), 6 (75%) experienced a 50% 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 prednisone. The dose of thalidomide in this study (50mg/day) 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. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: A. Quintas-Cardama, H. M. Kantarjian, T. Manshouri, D. Thomas, J. Cortes, F. Ravandi, G. Garcia-Manero, A. Ferrajoli, C. Bueso-Ramos, and S. Verstovsek Lenalidomide Plus Prednisone Results in Durable Clinical, Histopathologic, and Molecular Responses in Patients With Myelofibrosis J. Clin. Oncol., October 1, 2009; 27(28): 4760 - 4766. 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