Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Giagounidis, Aristoteles ; Mufti, Ghulam J. ; Mittelman, Moshe ; Sanz, Guillermo ; Platzbecker, Uwe ; Muus, Petra ; Selleslag, Dominik ; Beyne-Rauzy, Odile ; te Boekhorst, Peter and del Canizo, Consuelo , et al. (2014) In European Journal of Haematology 93(5). p.429-438
Abstract
ObjectiveA 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). MethodsPatients received lenalidomide 10mg/d (days 1-21; n=47) or 5mg/d (days 1-28; n=43) on 28-d cycles or placebo (n=45). From the placebo and lenalidomide 5mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10mg at 16wk, respectively. ResultsRates of red blood cell-transfusion independence (RBC-TI) 182d were higher in the lenalidomide 10mg (57.4%; P<0.0001) and 5mg (37.2%; P=0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major+minor... (More)
ObjectiveA 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). MethodsPatients received lenalidomide 10mg/d (days 1-21; n=47) or 5mg/d (days 1-28; n=43) on 28-d cycles or placebo (n=45). From the placebo and lenalidomide 5mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10mg at 16wk, respectively. ResultsRates of red blood cell-transfusion independence (RBC-TI) 182d were higher in the lenalidomide 10mg (57.4%; P<0.0001) and 5mg (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 10mg, 5mg, and placebo groups, respectively. In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI 182d vs. non-responders (P=0.0072). The most common grade 3-4 adverse event was myelosuppression. ConclusionsThese 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). (Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
acute myeloid leukaemia, del(5q), lenalidomide, myelodysplastic, syndromes, transfusion independence
in
European Journal of Haematology
volume
93
issue
5
pages
429 - 438
publisher
Wiley-Blackwell
external identifiers
  • wos:000343970700010
  • scopus:84911955301
  • pmid:24813620
ISSN
1600-0609
DOI
10.1111/ejh.12380
language
English
LU publication?
yes
id
26a93792-65db-42bf-9609-9c86a6adfc64 (old id 4876016)
date added to LUP
2016-04-01 10:24:41
date last changed
2022-08-20 02:34:27
@article{26a93792-65db-42bf-9609-9c86a6adfc64,
  abstract     = {{ObjectiveA 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). MethodsPatients received lenalidomide 10mg/d (days 1-21; n=47) or 5mg/d (days 1-28; n=43) on 28-d cycles or placebo (n=45). From the placebo and lenalidomide 5mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10mg at 16wk, respectively. ResultsRates of red blood cell-transfusion independence (RBC-TI) 182d were higher in the lenalidomide 10mg (57.4%; P&lt;0.0001) and 5mg (37.2%; P=0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major+minor responses) were 56.8% (P&lt;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 10mg, 5mg, and placebo groups, respectively. In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI 182d vs. non-responders (P=0.0072). The most common grade 3-4 adverse event was myelosuppression. ConclusionsThese 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).}},
  author       = {{Giagounidis, Aristoteles and Mufti, Ghulam J. and Mittelman, Moshe and Sanz, Guillermo and Platzbecker, Uwe and Muus, Petra and Selleslag, Dominik and Beyne-Rauzy, Odile and te Boekhorst, Peter and del Canizo, Consuelo and Guerci-Bresler, Agnes and Nilsson, Lars and Luebbert, Michael and Quesnel, Bruno and Ganser, Arnold and Bowen, David and Schlegelberger, Brigitte and Goehring, Gudrun and Fu, Tommy and Benettaib, Bouchra and Hellstrom-Lindberg, Eva and Fenaux, Pierre}},
  issn         = {{1600-0609}},
  keywords     = {{acute myeloid leukaemia; del(5q); lenalidomide; myelodysplastic; syndromes; transfusion independence}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{429--438}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{European Journal of Haematology}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1111/ejh.12380}},
  doi          = {{10.1111/ejh.12380}},
  volume       = {{93}},
  year         = {{2014}},
}