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- Document type:
- Clinical Trial, Phase II; Journal Article; Multicenter Study; Article
- Author(s):
- 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
- Title:
- Peripheral blood cytogenetics allows treatment monitoring and early identification of treatment failure to lenalidomide in MDS patients: results of the LE-MON-5 trial.
- Abstract:
- 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.EudraCT:2008-001866-10.
- Journal title abbreviation:
- Ann Hematol
- Year:
- 2017
- Journal volume:
- 96
- Journal issue:
- 6
- Pages contribution:
- 887-894
- Language:
- eng
- Fulltext / DOI:
- doi:10.1007/s00277-017-2983-0
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/28374162
- Print-ISSN:
- 0939-5555
- TUM Institution:
- III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie)
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