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Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower-risk MDS without 5q deletion

By Andrea Toma, O. Kosmider, S. Chevret, J. Delaunay, A. Stamatoullas, C. Rose, O. Beyne-Rauzy, A. Banos, A. Guerci-Bresler, S. Wickenhauser, D. Caillot, K. Laribi, B. De Renzis, Dominique Bordessoule, C. Gardin, B. Slama, L. Sanhes, B. Gruson, P. Cony-Makhoul, B. Chouffi, C. Salanoubat, R. Benramdane, L. Legros, E. Wattel, G. Tertian, K. Bouabdallah, F. Guilhot, A. L. Taksin, S. Cheze, K. Maloum, S. Nimuboma, C. Soussain, F. Isnard, E. Gyan, R. Petit, J. Lejeune, V. Sardnal, A. Renneville, C. Preudhomme, M. Fontenay, P. Fenaux and F Dreyfus

Abstract

International audienceAfter failure of erythropoiesis-stimulating agents (ESAs), lenalidomide (LEN) yields red blood cell (RBC) transfusion independence (TI) in 20-30% of lower-risk non-del5q myelodysplastic syndrome (MDS). Several observations suggest an additive effect of ESA and LEN in this situation. We performed a randomized phase III study in 131 RBC transfusion-dependent (TD, median transfusion requirement six RBC units per 8 weeks) lower-risk ESA-refractory non-del5q MDS. Patients received LEN alone, 10 mg per day, 21 days per 4 weeks (L arm) or LEN (same schedule) + erythropoietin (EPO) beta, 60,000 U per week (LE arm). In an intent-to-treat (ITT) analysis, erythroid response (HI-E, IWG 2006 criteria) after four treatment cycles (primary end point) was 23.1% (95% CI 13.5-35.2) in the L arm and 39.4% (95% CI 27.6-52.2) in the LE arm (P=0.044), while RBC-TI was reached in 13.8 and 24.2% of the patients in the L and LE arms, respectively (P=0.13). Median response duration was 18.1 and 15.1 months in the L and LE arms, respectively (P=0.47). Side effects were moderate and similar in the two arms. Low baseline serum EPO level and a G polymorphism of CRBN gene predicted HI-E. Combining LEN and EPO significantly improves erythroid response over LEN alone in lower-risk non-del5q MDS patients with anemia resistant to ES

Topics: [SDV] Life Sciences [q-bio], [SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology
Publisher: HAL CCSD
Year: 2016
DOI identifier: 10.1038/leu.2015.296
OAI identifier: oai:HAL:hal-01321412v1
Provided by: Hal-Diderot

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