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Blood, 23 April 2009, Vol. 113, No. 17, pp. 3947-3952. Prepublished online as a Blood First Edition Paper on November 5, 2008; DOI 10.1182/blood-2008-08-175778. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-08-175778v1 113/17/3947    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 Ades, L. Articles by Fenaux, P. Search for Related Content PubMed PubMed Citation Articles by Ades, L. Articles by Fenaux, P. Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted August 29, 2008 Accepted October 24, 2008 Efficacy and safety of lenalidomide in intermediate-2-or high risk myelodysplastic syndromes (MDS) with 5q deletion: Results of a phase II study Lionel Ades, Simone Boehrer, Thomas Prebet, Odile Beyne-Rauzy, Laurence Legros, Christophe Ravoet, Francois Dreyfus, Aspasia Stamatoullas, Marie Pierre Chaury, Jacques Delaunay, Guy Laurent, Norbert Vey, Sara Burcheri, Rose-Marie Mbida, Natacha Hoarau, Claude Gardin, and Pierre Fenaux* Hopital Avicenne, Universite Paris 13, Paris, France Institut Paoli Calmettes, Marseille, France Centre hospitalo-universitaire de Toulouse, Toulouse, France Centre hospitalo-universitaire Nice, Nice, France Hopital de Jolimont- la louviere -Belgium, Bruxelles, Belgium Hopital Cochin, Universite paris 5, Paris, France Centre hospitalo-universitaire de Caen, Caen, France Centre hospitalo-universitaire de Limoges, Limoges, France Centre hospitalo-universitaire de Nantes, Nantes, France Group Francophone des syndomes myelodysplasiques, France INSERM U848, Institut Gustave Roussy, Villejuif, France * Corresponding author; email: pierre.fenaux{at}avc.aphp.fr. Lenalidomide is the treatment of choice in lower risk MDS with 5q deletion and may have a inhibitory activity on the del 5q clone. Higher risk MDS with del5q carry a poorer prognosis. In this phase II trial, 47 patients with higher risk MDS received lenalidomide 10 mg/day. Two patients had pure RA, 1 RCMD-RS, 6 RAEB-1, 20 RAEB-2 and 18 RAEB-t (WH0 AML). IPSS was high in 60%, INT-2 in 40%. Del 5q was isolated, with 1 additional and >1 additional abnormality in 19%, 23% and 58% patients, respectively. Thirteen (27%) patients achieved hematological response, including 7 CR (with complete (4) or partial (3) cytogenetic response), 2 marrow CR and 4 hematological improvements (HI-E) and 12 became RBC-transfusion independent, for a median duration of 6.5 months. Median CR duration was 11.5 months. Six of 9 (67%) patients with isolated del 5q achieved CR, versus 1 of 11 and none of 27 patients with one or more than one additional abnormality, respectively (p<0.001). Seven of 20 (35%) with initial platelets > 100,000/mm3 obtained CR, compared to none of the 27 with lower platelet counts < 100,000/mm3 (p=0.001). Our data support a potential role of lenalidomide in higher risk MDS with isolated del 5q, but this drug, at least as single agent, has limited efficacy in higher risk MDS with del 5q and additional cytogenetic abnormalities'. This study was registered at www.ClinicalTrials.gov as NCT00424229. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: REVelation (del: 5q) Mikkael A. Sekeres Blood 2009 113: 3888-3889. [Full Text] [PDF] This article has been cited by other articles: M. A. Sekeres REVelation (del: 5q) Blood, April 23, 2009; 113(17): 3888 - 3889. [Full Text] [PDF]

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