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




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1 Service greffe de moelle osseuse 2 IMRB - Institut Mondor de Recherche Biomédicale 3 UMR 8104 Institut Cochin 4 UPD5 Médecine - Université Paris Descartes - Faculté de Médecine 5 CHU Nantes 6 CRLCC Henri Becquerel 7 Laboratoire d-Hématologie 8 Hôpital Purpan 9 CHU Strasbourg 10 CHU Nancy - Centre hospitalier de Nancy 11 CHU de Nîmes - Centre Hospitalier Universitaire de Nîmes 12 CHU Dijon 13 CHU Le MAns 14 Hôpital Universitaire d-Amiens 15 CHU Limoges 16 Hôpital avicenne 17 CHA - Centre Hospitalier d-Avignon 18 Centre Hospitalier d-Annecy 19 Centre hospitalier de Boulogne sur mer 20 Hôpital de Corbeil-ESsonnes 21 Centre Hospitalier René Dubos, Cergy Pontoise 22 CHU de Nice - Centre Hospitalier Universitaire de Nice 23 VPV - Virologie et pathogenèse virale 24 AP-HP Hôpital Bicêtre Le Kremlin-Bicêtre 25 Centre Hospitalier Universitaire de Bordeaux 26 INSERM CIC 0802, CHU de Poitiers - INSERM CIC 0802 27 Centre Hospitalier de Versailles CHV 28 CHU Caen 29 Service d-Hématologie Biologique CHU Pitié-Salpêtrière 30 Département d’Immunologie Biologique AP-HP - Hôpital Saint-Antoine, Paris 31 CHU Pontchaillou Rennes 32 Centre René Huguenin 33 Centre Hospitalier Régional Universitaire de Tours 34 CRESS - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité 35 U1016 Institut Cochin, Department of Immunology-Hematology 36 Hôpitaux Cochin Broca Hôtel Dieu, Service d-Hématologie Biologique 37 AP-HP - Hôpital Cochin Broca Hôtel Dieu Paris

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





Autor: Andrea Toma - O.
Kosmider - S.
Chevret - J.
Delaunay - A.
Stamatoullas - C.
Rose - O.
Beyne-Rauzy - A.
Banos - A.
Guerci-Bresler


Fuente: https://hal.archives-ouvertes.fr/



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