title: Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study.
abstract: 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.
authors.affiliation: Hôpital Avicenne, Université Paris, Paris, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.forename: Simone
authors.initials: S
authors.lastname: Boehrer
authors.forename: Thomas
authors.initials: T
authors.lastname: Prebet
authors.forename: Odile
authors.initials: O
authors.lastname: Beyne-Rauzy
authors.forename: Laurence
authors.initials: L
authors.lastname: Legros
authors.forename: Christophe
authors.initials: C
authors.lastname: Ravoet
authors.forename: François
authors.initials: F
authors.lastname: Dreyfus
authors.forename: Aspasia
authors.initials: A
authors.lastname: Stamatoullas
authors.forename: Marie Pierre
authors.initials: MP
authors.lastname: Chaury
authors.forename: Jacques
authors.initials: J
authors.lastname: Delaunay
authors.forename: Guy
authors.initials: G
authors.lastname: Laurent
authors.forename: Norbert
authors.initials: N
authors.lastname: Vey
authors.forename: Sara
authors.initials: S
authors.lastname: Burcheri
authors.forename: Rose-Marie
authors.initials: RM
authors.lastname: Mbida
authors.forename: Natacha
authors.initials: N
authors.lastname: Hoarau
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002872:Chromosome Deletion; D002877:Chromosomes, Human / Q000235:genetics*; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D011379:Prognosis; D012307:Risk Factors; D015996:Survival Rate; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide