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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

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)
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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
2021-10-06 01:32:55
@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},
  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},
}