Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study

被引:154
作者
Gattermann, Norbert [1 ]
Finelli, Carlo [2 ]
Della Porta, Matteo [3 ]
Fenaux, Pierre [4 ]
Ganser, Arnold [5 ]
Guerci-Bresler, Agnes [6 ]
Schmid, Mathias [7 ]
Taylor, Kerry [8 ]
Vassilieff, Dominique [9 ]
Habr, Dany [10 ]
Domokos, Gabor [11 ]
Roubert, Bernard [11 ]
Rose, Christian [12 ]
机构
[1] Heinrich Heine Univ, Dept Haematol Oncol & Clin Immunol, D-40225 Dusseldorf, Germany
[2] St Orsola Marcello Malpighi Hosp, Bologna, Italy
[3] Univ Pavia, Sch Med, IRCCS Policlin S Matteo, I-27100 Pavia, Italy
[4] Univ Paris 13, Hop Avicenne, AP HP, Bobigny, France
[5] Hannover Med Sch, D-30623 Hannover, Germany
[6] CHU Brabois, Vandoeuvre Les Nancy, France
[7] Univ Hosp, Ulm, Germany
[8] Mater Hosp, Brisbane, Qld, Australia
[9] Univ Paris 05, Hop Cochin, AP HP, Paris, France
[10] Novartis Pharmaceut, E Hanover, NJ USA
[11] Novartis Pharma AG, Basel, Switzerland
[12] Hop St Vincent de Paul, Lille, France
关键词
Myelodysplastic syndromes; Deferasirox; Serum ferritin; Labile plasma iron; Iron chelation therapy; LABILE PLASMA IRON; OXIDATIVE STRESS; SERUM FERRITIN; MDS PATIENTS; CHELATION; THERAPY; ANEMIAS; MULTICENTER; THALASSEMIA; LPI;
D O I
10.1016/j.leukres.2010.03.009
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500 ng/mL, similar to 50% were chelation-naive. Overall median serum ferritin decreased significantly at 1 year (p = 0.002). Decreases occurred irrespective of whether patients were chelation-naive or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p < 0.0001). This large dataset prospectively confirms the efficacy and well characterizes the safety profile of deferasirox in MDS. (C) 2010 Elsevier Ltd. All rights reserved.
引用
收藏
页码:1143 / 1150
页数:8
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