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Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study.

par Adès, Lionel;Boehrer, S;Prebet, Thomas;Beyne-Rauzy, Odile;Legros, Laurence;Ravoet, Christophe;Dreyfus, François;Stamatoullas, Aspasia;Chaury, Marie Pierre;Delaunay, Jacques;Laurent, Gauthier ;Vey, Norbert;Burcheri, Sara;Mbida, Rose-Marie;Hoarau, Natacha;Gardin, C;Fenaux, Pierre
Référence Blood, 113, 17, page (3947-3952)
Publication Publié, 2009-04

Article révisé par les pairs

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Résumé :

Higher-risk MDS with del5q carry a poor prognosis. In this phase 2 trial, 47 patients with higher-risk MDS received lenalidomide 10 mg/day. International Prognostic Scoring System was high in 60%, intermediate-2 risk in 40%. del 5q was isolated, with one additional and more than one additional abnormality in 19%, 23%, and 58% patients, respectively. Thirteen (27%) patients achieved hematologic response, including 7 hematologic complete remission (CR) (with complete [4] or partial [3] cytogenetic response), 2 marrow CR and 4 hematologic improvement erythroid, and 12 became red blood cell (RBC) transfusion independent, for a median duration of 6.5 months. Median CR duration was 11.5 months. Six of 9 (67%) patients with isolated del 5q achieved CR, versus 1 of 11 and none of 27 patients with one or more than one additional abnormality, respectively (P < .001). Seven of 20 (35%) with initial platelets more than 100,000/mm(3) obtained CR, compared with none of the 27 with lower platelet counts less than 100,000/mm(3) (P = .001). Our data support a potential role of lenalidomide in higher-risk MDS with isolated del 5q.