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Journal Articles Leukemia Year : 2016

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

1 Service greffe de moelle osseuse
2 IMRB - Institut Mondor de Recherche Biomédicale
3 IC UM3 (UMR 8104 / U1016) - Institut Cochin
4 UPD5 Médecine - Université Paris Descartes - Faculté de Médecine
5 CHU Nantes - Centre hospitalier universitaire de Nantes
6 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
7 Laboratoire d'Hématologie
8 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
9 CHU Strasbourg
10 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
11 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
12 CHU Dijon
13 Centre Hospitalier Le Mans (CH Le Mans)
14 CHU Amiens-Picardie
15 CRIBL - Contrôle de la Réponse Immune B et des Lymphoproliférations
16 Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
17 Hôpital Avicenne [AP-HP]
18 Centre Hospitalier Henri Duffaut (Avignon)
19 Centre Hospitalier d'Annecy
20 Centre hospitalier de Boulogne sur mer
21 Hôpital de Corbeil-ESsonnes
22 Centre Hospitalier René Dubos [Pontoise]
23 CHU de Nice - Centre Hospitalier Universitaire de Nice
24 VPV - Virologie et pathogenèse virale
25 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
26 CHU Bordeaux [Bordeaux]
27 INSERM - CHU de Poitiers - INSERM CIC 0802
28 CHV - Centre Hospitalier de Versailles André Mignot
29 CHU Caen
30 Service d'Hématologie Biologique [CHU Pitié-Salpêtrière]
31 CHU Saint-Antoine [AP-HP]
32 CHU Pontchaillou [Rennes]
33 CRLCC René Huguenin
34 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
35 CRESS (U1153 / UMR_A_1125 / UMR_S_1153) - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité
36 [Institut Cochin] Departement Infection, immunité, inflammation
37 Hôpital Cochin [AP-HP]
38 AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris]
A. Banos
  • Function : Author
D. Caillot
  • Function : Author
B. de Renzis
  • Function : Author
B. Gruson
  • Function : Author
F. Guilhot
  • Function : Author
S. Cheze
  • Function : Author
C. Soussain
  • Function : Author

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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hal-01321412 , version 1 (06-10-2016)

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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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