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Blood, 1 January 2008, Vol. 111, No. 1, pp. 86-93.
Prepublished online as a Blood First Edition Paper on September 24, 2007; DOI 10.1182/blood-2007-01-068833.
 Previous Article | Next Article 
Submitted January 22, 2007
Accepted September 10, 2007
Phase II study of lenalidomide in transfusion-dependent, low- and intermediate-1-risk myelodysplastic syndromes with karyotypes other than deletion 5q
Azra Raza, James A. Reeves, Eric J. Feldman, Gordon W. Dewald, John M. Bennett, H. Joachim Deeg, Luke Dreisbach, Charles A. Schiffer, Richard M. Stone, Peter L. Greenberg, Peter T. Curtin, Virginia M. Klimek, Jamile M. Shammo, Deborah Thomas, Robert D. Knight, Michele Schmidt, Kenton Wride, Jerome B. Zeldis, and Alan F. List*
Section of Hematology and Stem Cell Transplantation, Rush University Medical Center, Chicago, IL
Florida Cancer Specialists, Fort Myers, FL
Weill Medical College of Cornell University, New York, NY
Cytogenetics Laboratory, Mayo Clinic, Rochester, MN
James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY
Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA
Eisenhower Medical Center, Rancho Mirage, CA
Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI
Medical Oncology/Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA
Stanford Comprehensive Cancer Center, Stanford University Medical Center, Stanford, CA
Oregon Cancer Center, Oregon Health and Science University, Portland, OR
Hematology Service, Memorial Sloan-Kettering Cancer Center, New York, NY
Department of Leukemia, M. D. Anderson Cancer Center, Houston, TX
Celgene Corporation, Summit, NJ
Malignant Hematology Division, H. Lee Moffitt Cancer Center, Tampa, FL
* Corresponding author; email: alan.list{at}moffitt.org.
Lenalidomide is approved for red blood cell (RBC) transfusion-dependent anemia due to low or intermediate-1 (int-1) myelodysplastic syndromes (MDS) associated with a chromosome 5q deletion with or without additional cytogenetic abnormalities. We report results of a multicenter, phase II trial evaluating lenalidomide therapy for transfusion-dependent patients with low- or int-1-risk MDS without deletion 5q. Eligible patients had  50,000/mm3 platelets and required 2 RBC units within the previous 8 weeks; 214 patients received oral lenalidomide 10 mg daily or 10 mg on days 1 to 21 of a 28-day cycle. The most common grade 3/4 adverse events were neutropenia (30%) and thrombocytopenia (25%). Using an intention-to-treat analysis, 56 (26%) patients achieved transfusion independence (TI) after a median of 4.8 weeks of treatment with a median duration of TI of 41.0 weeks. In patients who achieved TI, the median rise in hemoglobin was 3.2 g/dL (range, 1.0 to 9.8) from baseline. A 50% reduction in transfusion requirement occurred in another 37 patients, yielding a 43% overall rate of hematologic improvement (TI response + 50% reduction in transfusion requirement). Lenalidomide has clinically meaningful activity in transfusion-dependent patients with low- or int-1-risk MDS who lack the deletion 5q karyotypic abnormality. This study is registered at www.clinicaltrials.gov as #NCT00064974.
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