title: Lenalidomide in International Prognostic Scoring System Low and Intermediate-1 risk myelodysplastic syndromes with del(5q): an Italian phase II trial of health-related quality of life, safety and efficacy.
abstract: In lower-risk myelodysplastic syndromes (MDS) with del(5q), lenalidomide induces erythroid responses associated with better survival. In a phase II, single-arm trial, 45 patients with anemia and lower-risk del(5q) MDS received lenalidomide 10 mg/day to evaluate quality of life (QoL) changes, measured by QOL-E, safety, responses and survival. Lenalidomide was well tolerated, with 80% completing ≥ 24 weeks of treatment. Earlier study discontinuation was related to disease progression (n = 5), death (n = 1) and withdrawal of consent (n = 3). Within 24 weeks, 82% obtained erythroid responses, durable in 69% at 52 weeks. Cytogenetic responses occurred in 29 patients (64%), with 10 patients achieving a complete cytogenetic response. QoL-E scores correlated with hemoglobin levels and improved in erythroid responders. Erythroid responders had an 86% reduced risk of disease progression and an 80% reduction in mortality risk compared with non-responders. These findings corroborate earlier studies and give further support to the use of lenalidomide in lower-risk MDS and del(5q).
authors: "Bianchi-Melacrino-Morelli" Hospital , Reggio Calabria , Italy.
authors: Esther N
authors: EN
authors: Oliva
authors: Roberto
authors: R
authors: Latagliata
authors: Carmelo
authors: C
authors: Laganà
authors: Massimo
authors: M
authors: Breccia
authors: Sara
authors: S
authors: Galimberti
authors: Fortunato
authors: F
authors: Morabito
authors: Antonella
authors: A
authors: Poloni
authors: Enrico
authors: E
authors: Balleari
authors: Agostino
authors: A
authors: Cortelezzi
authors: Giuseppe
authors: G
authors: Palumbo
authors: Grazia
authors: G
authors: Sanpaolo
authors: Antonio
authors: A
authors: Volpe
authors: Giorgina
authors: G
authors: Specchia
authors: Carlo
authors: C
authors: Finelli
authors: Maria Grazia
authors: MG
authors: D'Errigo
authors: Filippo
authors: F
authors: Rodà
authors: Caterina
authors: C
authors: Alati
authors: Giuliana
authors: G
authors: Alimena
authors: Francesco
authors: F
authors: Nobile
authors: Maria A
authors: MA
authors: Aloe Spiriti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D002872:Chromosome Deletion; D002895:Chromosomes, Human, Pair 5; D018450:Disease Progression; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality; D011788:Quality of Life; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D013792:Thalidomide; D000077269:Lenalidomide