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Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study
- Source :
- European Journal of Haematology, European Journal of Haematology, 93, 5, pp. 429-38, EUROPEAN JOURNAL OF HAEMATOLOGY, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, European Journal of Haematology, 93, 429-38
- Publication Year :
- 2014
-
Abstract
- Item does not contain fulltext OBJECTIVE: A subset analysis of the randomised, phase 3, MDS-004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)-defined Low-/Intermediate (Int)-1-risk myelodysplastic syndromes (MDS) with isolated del(5q). METHODS: Patients received lenalidomide 10 mg/d (days 1-21; n = 47) or 5 mg/d (days 1-28; n = 43) on 28-d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively. RESULTS: Rates of red blood cell-transfusion independence (RBC-TI) >/=182 d were higher in the lenalidomide 10 mg (57.4%; P < 0.0001) and 5 mg (37.2%; P = 0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major + minor responses) were 56.8% (P < 0.0001), 23.1% (P = 0.0299) and 0%, respectively. Two-year cumulative risk of acute myeloid leukaemia progression was 12.6%, 17.4% and 16.7% in the lenalidomide 10 mg, 5 mg, and placebo groups, respectively. In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI >/=182 d vs. non-responders (P = 0.0072). The most common grade 3-4 adverse event was myelosuppression. CONCLUSIONS: These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low-/Int-1-risk MDS with isolated del(5q).
- Subjects :
- Adult
Male
Risk
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
lenalidomide
Antineoplastic Agents
Drug Administration Schedule
Humans
del(5q)
acute myeloid leukaemia
Aged
Retrospective Studies
Aged, 80 and over
transfusion independence
Original Articles
Middle Aged
Survival Analysis
myelodysplastic syndromes
Thalidomide
Leukemia, Myeloid, Acute
Treatment Outcome
Cytogenetic Analysis
Disease Progression
Chromosomes, Human, Pair 5
Female
Chromosome Deletion
Erythrocyte Transfusion
Subjects
Details
- ISSN :
- 16000609 and 09024441
- Volume :
- 93
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- European journal of haematology
- Accession number :
- edsair.pmid.dedup....2ae12171b4d0d34e17076b710a3bd706