Lenalidomide with or without erythropoietin in transfusion dependent erythropoiesis-stimulating agent-refractory lower risk MDS without 5q deletion.
Fiche publication
Date publication
octobre 2015
Auteurs
Membres identifiés du Cancéropôle Est :
Dr CAILLOT Denis, Dr GUERCI-BRESLER Agnès
Tous les auteurs :
Toma A, Kosmider O, Chevret S, Delaunay J, Stamatoullas A, Rose C, Beyne-Rauzy O, Banos A, Guerci-Bresler A, Wickenhauser S, Caillot D, Laribi K, De Renzis B, Bordessoule D, Gardin C, Slama B, Sanhes L, Gruson B, Makhoul PC, Chouffi B, Salanoubat C, Benramdane R, Legros L, Wattel E, Tertian G, Bouabdallah K, Guilhot F, Taksin AL, Cheze S, Maloum K, Nimuboma S, Soussain C, Isnard F, Gyan E, Petit R, Lejeune J, Sardnal V, Renneville A, Preudhomme C, Fontenay M, Fenaux P, Dreyfus F
Lien Pubmed
Résumé
After failure of erythropoiesis-stimulating agents (ESA), Lenalidomide (LEN) yields red blood cells (RBC) transfusion independence (TI) in 20-30% of lower risk non-del5q 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 6 RBC units/8weeks) lower risk ESA-refractory non-del5q MDS. Patients received LEN alone, 10 mg/day, 21 days/4 weeks (L arm) or LEN (same schedule)+erythropoietin (EPO) beta, 60 000 U/week (LE arm). In an intent-to-treat (ITT) analysis, erythroid response (HI-E, IWG 2006 criteria) after 4 treatment cycles (primary endpoint) 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 transfusion independence (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 2 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.Leukemia accepted article preview online, 26 October 2015. doi:10.1038/leu.2015.296.
Référence
Leukemia. 2015 Oct 26