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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. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-01-068833v1 111/1/86    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 Raza, A. Articles by List, A. F. Search for Related Content PubMed PubMed Citation Articles by Raza, A. Articles by List, A. F. Related Collections Neoplasia Immunotherapy Free Research Articles Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1–risk myelodysplastic syndromes with karyotypes other than deletion 5q Azra Raza1, James A. Reeves2, Eric J. Feldman3, Gordon W. Dewald4, John M. Bennett5, H. Joachim Deeg6, Luke Dreisbach7, Charles A. Schiffer8, Richard M. Stone9, Peter L. Greenberg10, Peter T. Curtin11, Virginia M. Klimek12, Jamile M. Shammo1, Deborah Thomas13, Robert D. Knight14, Michele Schmidt14, Kenton Wride14, Jerome B. Zeldis14, and Alan F. List15 1 Rush University Medical Center, Chicago, IL; 2 Florida Cancer Specialists, Fort Myers; 3 Weill Medical College of Cornell University, New York, NY; 4 Mayo Clinic, Rochester, MN; 5 James P. Wilmot Cancer Center, University of Rochester Medical Center, NY; 6 Fred Hutchinson Cancer Research Center, Seattle, WA; 7 Eisenhower Medical Center, Rancho Mirage, CA; 8 Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI; 9 Dana-Farber Cancer Institute, Boston, MA; 10 Stanford University Medical Center, CA; 11 Oregon Health and Sciences University, Portland; 12 Memorial Sloan-Kettering Cancer Center, New York, NY; 13 M. D. Anderson Cancer Center, Houston, TX; 14 Celgene, Summit, NJ; and 15 H. Lee Moffitt Cancer Center, Tampa, FL Lenalidomide is approved for red blood cell (RBC) transfusion-dependent anemia due to low or intermediate-1 (int-1) risk myelodysplastic syndromes (MDSs) associated with a chromosome 5q deletion with or without additional cytogenetic abnormalities. We report results of a multicenter, phase 2 trial evaluating lenalidomide therapy for transfusion-dependent patients with low- or int-1–risk MDS without deletion 5q. Eligible patients had 50 000/mm3 or more platelets and required 2 U or more RBCs within the previous 8 weeks; 214 patients received 10 mg oral lenalidomide 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 32 g/L (3.2 g/dL; range, 10-98 g/L [1.0-9.8 g/dL]) from baseline. A 50% or greater reduction in transfusion requirement occurred in 37 additional 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 no. NCT00064974 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: "Fairest of them all" for myelodysplastic syndromes Elihu H. Estey Blood 2008 111: 6. [Full Text] [PDF] This article has been cited by other articles: R. M. Stone How I treat patients with myelodysplastic syndromes Blood, June 18, 2009; 113(25): 6296 - 6303. [Full Text] [PDF] R. M. Lyons, T. M. Cosgriff, S. S. Modi, R. H. Gersh, J. D. Hainsworth, A. L. Cohn, H. J. McIntyre, I. J. Fernando, J. T. Backstrom, and C.L. Beach Hematologic Response to Three Alternative Dosing Schedules of Azacitidine in Patients With Myelodysplastic Syndromes J. Clin. Oncol., April 10, 2009; 27(11): 1850 - 1856. [Abstract] [Full Text] [PDF] M. Y. Follo, C. Finelli, C. Clissa, S. Mongiorgi, C. Bosi, G. Martinelli, M. Baccarani, L. Manzoli, A. M. Martelli, and L. Cocco Phosphoinositide-Phospholipase C {beta}1 Mono-Allelic Deletion Is Associated With Myelodysplastic Syndromes Evolution Into Acute Myeloid Leukemia J. Clin. Oncol., February 10, 2009; 27(5): 782 - 790. [Abstract] [Full Text] [PDF] T. A. Fehniger, J. C. Byrd, G. Marcucci, C. N. Abboud, C. Kefauver, J. E. Payton, R. Vij, and W. Blum Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13 Blood, January 29, 2009; 113(5): 1002 - 1005. [Abstract] [Full Text] [PDF] G. Garcia-Manero Standard-of-care Approaches for Myelodysplastic Syndromes ASCO Educational Book, January 1, 2009; 2009(1): 408 - 412. [Abstract] [Full Text] [PDF] M. A. Sekeres, J. P. Maciejewski, A. A.N. Giagounidis, K. Wride, R. Knight, A. Raza, and A. F. List Relationship of Treatment-Related Cytopenias and Response to Lenalidomide in Patients With Lower-Risk Myelodysplastic Syndromes J. Clin. Oncol., December 20, 2008; 26(36): 5943 - 5949. [Abstract] [Full Text] [PDF] Lenalidomide for Myelodysplasia Journal Watch Oncology and Hematology, January 22, 2008; 2008(122): 4 - 4. [Full Text]

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