Peripheral blood cytogenetics allows treatment monitoring and early identification of treatment failure to lenalidomide in MDS patients: results of the LE-MON-5 trial
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Peripheral blood cytogenetics allows treatment monitoring and early identification of treatment failure to lenalidomide in MDS patients: results of the LE-MON-5 trial. / Braulke, Friederike; Schulz, Xenia; Germing, Ulrich; Schuler, Esther; Platzbecker, Uwe; Nolte, Florian; Hofmann, Wolf-Karsten; Giagounidis, Aristoteles; Götze, Katharina; Lübbert, Michael; Schlenk, Richard F; Schanz, Julie; Bacher, Ulrike; Ganser, Arnold; Büsche, Guntram; Letsch, Anne; Schafhausen, Philippe; Bug, Gesine; Brümmendorf, Tim H; Haas, Rainer; Trümper, Lorenz; Shirneshan, Katayoon; Haase, Detlef.
in: ANN HEMATOL, Jahrgang 96, Nr. 6, 06.2017, S. 887-894.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Peripheral blood cytogenetics allows treatment monitoring and early identification of treatment failure to lenalidomide in MDS patients: results of the LE-MON-5 trial
AU - Braulke, Friederike
AU - Schulz, Xenia
AU - Germing, Ulrich
AU - Schuler, Esther
AU - Platzbecker, Uwe
AU - Nolte, Florian
AU - Hofmann, Wolf-Karsten
AU - Giagounidis, Aristoteles
AU - Götze, Katharina
AU - Lübbert, Michael
AU - Schlenk, Richard F
AU - Schanz, Julie
AU - Bacher, Ulrike
AU - Ganser, Arnold
AU - Büsche, Guntram
AU - Letsch, Anne
AU - Schafhausen, Philippe
AU - Bug, Gesine
AU - Brümmendorf, Tim H
AU - Haas, Rainer
AU - Trümper, Lorenz
AU - Shirneshan, Katayoon
AU - Haase, Detlef
PY - 2017/6
Y1 - 2017/6
N2 - Transfusion-dependent patients with low- or intermediate-1-risk myelodysplastic syndrome, <5% bone marrow (BM) blasts and isolated 5q-deletion received lenalidomide within the German MDS study group phase-II clinical trial LE-MON-5 (EudraCT:2008-001866-10) of the University of Duesseldorf, Germany. Cytogenetic monitoring was performed by chromosome banding analyses (CBA) of BM cells and fluorescence in situ hybridization (FISH) analyses of peripheral blood (PB) mononuclear CD34+ cells using extended probe panels. Out of 144 patients screened for study enrollment, 24% failed to meet inclusion criteria due to cytogenetic findings. Eighty-seven patients were followed with a median observation time of 30 months. Cytogenetic response detected by FISH and CBA in 74 and 66% of patients, respectively, was predictive for hematologic response as well as of high prognostic relevance. After 2 years, AML rate was 8% for all patients. Karyotype evolution was detected in 21 (FISH)-34% (CBA) of patients associated with significantly shorter AML-free survival. Disease progression was first detectable on the cytogenetic level on average 5-6 months before recurrence of transfusion dependence. Our data show for the first time in a prospective setting that a cytogenetic monitoring from the PB helps to early identify treatment failure and progressive disease in lenalidomide-treated patients to improve clinical management.TRIAL REGISTRATION: EudraCT:2008-001866-10.
AB - Transfusion-dependent patients with low- or intermediate-1-risk myelodysplastic syndrome, <5% bone marrow (BM) blasts and isolated 5q-deletion received lenalidomide within the German MDS study group phase-II clinical trial LE-MON-5 (EudraCT:2008-001866-10) of the University of Duesseldorf, Germany. Cytogenetic monitoring was performed by chromosome banding analyses (CBA) of BM cells and fluorescence in situ hybridization (FISH) analyses of peripheral blood (PB) mononuclear CD34+ cells using extended probe panels. Out of 144 patients screened for study enrollment, 24% failed to meet inclusion criteria due to cytogenetic findings. Eighty-seven patients were followed with a median observation time of 30 months. Cytogenetic response detected by FISH and CBA in 74 and 66% of patients, respectively, was predictive for hematologic response as well as of high prognostic relevance. After 2 years, AML rate was 8% for all patients. Karyotype evolution was detected in 21 (FISH)-34% (CBA) of patients associated with significantly shorter AML-free survival. Disease progression was first detectable on the cytogenetic level on average 5-6 months before recurrence of transfusion dependence. Our data show for the first time in a prospective setting that a cytogenetic monitoring from the PB helps to early identify treatment failure and progressive disease in lenalidomide-treated patients to improve clinical management.TRIAL REGISTRATION: EudraCT:2008-001866-10.
KW - Acute Disease
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Angiogenesis Inhibitors
KW - Antigens, CD34
KW - Chromosome Banding
KW - Chromosome Deletion
KW - Chromosomes, Human, Pair 5
KW - Disease-Free Survival
KW - Female
KW - Germany
KW - Humans
KW - In Situ Hybridization, Fluorescence
KW - Karyotyping
KW - Leukemia, Myeloid
KW - Leukocytes, Mononuclear
KW - Male
KW - Middle Aged
KW - Myelodysplastic Syndromes
KW - Prognosis
KW - Thalidomide
KW - Treatment Failure
KW - Clinical Trial, Phase II
KW - Journal Article
KW - Multicenter Study
U2 - 10.1007/s00277-017-2983-0
DO - 10.1007/s00277-017-2983-0
M3 - SCORING: Journal article
C2 - 28374162
VL - 96
SP - 887
EP - 894
JO - ANN HEMATOL
JF - ANN HEMATOL
SN - 0939-5555
IS - 6
ER -