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

Andrea Toma 1, 2 O. Kosmider 3, 4 S. Chevret 1 J. Delaunay 5 A. Stamatoullas 6 C. Rose 7 O. Beyne-Rauzy 8 A. Banos 9 A. Guerci-Bresler 10 S. Wickenhauser 11 D. Caillot 12 K. Laribi 13 B. de Renzis 14 Dominique Bordessoule 15, 16 C. Gardin 17 B. Slama 18 L. Sanhes 18 B. Gruson 14 P. Cony-Makhoul 19 B. Chouffi 20 C. Salanoubat 21 R. Benramdane 22 L. Legros 23 E. Wattel 24, 2 G. Tertian 25 K. Bouabdallah 26 F. Guilhot 27 A. L. Taksin 28 S. Cheze 29 K. Maloum 30, 31 S. Nimuboma 32 C. Soussain 33 F. Isnard 31 E. Gyan 34 R. Petit 1 J. Lejeune 35 V. Sardnal 36 A. Renneville 7 C. Preudhomme 7 M. Fontenay 36, 3, 4, 37 P. Fenaux 1 F Dreyfus 38
Abstract : After 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 ESA
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Submitted on : Thursday, October 6, 2016 - 1:15:10 PM
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Andrea Toma, O. Kosmider, S. Chevret, J. Delaunay, A. Stamatoullas, et al.. Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower-risk MDS without 5q deletion. Leukemia, 2016, 30 (4), pp.897--905. ⟨10.1038/leu.2015.296⟩. ⟨hal-01321412⟩

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