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

2015; Springer Nature; Volume: 30; Issue: 4 Linguagem: Inglês

10.1038/leu.2015.296

1476-5551

Andréa Toma, Olivier Kosmider, Sylvie Chevret, J. Delaunay, Aspasia Stamatoullas, Christian Rosé, Odile Beyne‐Rauzy, A. Baños, A. Guerci-Bresler, Stefan Wickenhauser, Denis Caillot, Kamel Laribi, Benoît de Renzis, Dominique Bordessoule, Claude Gardin, Bohrane Slama, Laurence Sanhès, Bérengère Gruson, Pascale Cony‐Makhoul, Bachra Chouffi, Célia Salanoubat, Riad Benramdane, Laurence Legros, Eric Wattel, G. Tertian, Krimo Bouabdallah, François Guilhot, A.-L. Taksin, S. Chèze, Karim Maloum, S. Nimuboma, Carole Soussain, F Isnard, Emmanuel Gyan, Robert G. Petit, Julie Lejeune, Veronique Sardnal, Aline Renneville, Claude Preudhomme, Michaëla Fontenay, Pierre Fenaux, François Dreyfus,

Multiple Myeloma Research and Treatments

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.