Decitabine improves progression-free survival in older high-risk MDS patients with multiple autosomal monosomies: results of a subgroup analysis of the ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-11-23

AUTHORS

Michael Lübbert, Stefan Suciu, Anne Hagemeijer, Björn Rüter, Uwe Platzbecker, Aristoteles Giagounidis, Dominik Selleslag, Boris Labar, Ulrich Germing, Helmut R. Salih, Petra Muus, Karl-Heinz Pflüger, Hans-Eckart Schaefer, Lioudmila Bogatyreva, Carlo Aul, Theo de Witte, Arnold Ganser, Heiko Becker, Gerwin Huls, Lieke van der Helm, Edo Vellenga, Frédéric Baron, Jean-Pierre Marie, Pierre W. Wijermans, on behalf of the EORTC Leukemia Group and the German MDS Study Group

ABSTRACT

In a study of elderly AML patients treated with the hypomethylating agent decitabine (DAC), we noted a surprisingly favorable outcome in the (usually very unfavorable) subgroup with two or more autosomal monosomies (MK2+) within a complex karyotype (Lübbert et al., Haematologica 97:393-401, 2012). We now analyzed 206 myelodysplastic syndrome (MDS) patients (88 % of 233 patients randomized in the EORTC/GMDSSG phase III trial 06011, 61 of them with RAEBt, i.e. AML by WHO) with cytogenetics informative for MK status.. Endpoints are the following: complete/partial (CR/PR) and overall response rate (ORR) and progression-free (PFS) and overall survival (OS). Cytogenetic subgroups are the following: 63 cytogenetically normal (CN) patients, 143 with cytogenetic abnormalities, 73 of them MK-negative (MK−), and 70 MK-positive (MK+). These MK+ patients could be divided into 17 with a single autosomal monosomy (MK1) and 53 with at least two monosomies (MK2+). ORR with DAC in CN patients: 36.1 %, in MK− patients: 16.7 %, in MK+ patients: 43.6 % (MK1: 44.4 %, MK2+ 43.3 %). PFS was prolonged by DAC compared to best supportive care (BSC) in the CN (hazard ratio (HR) 0.55, 99 % confidence interval (CI), 0.26; 1.15, p = 0.03) and MK2+ (HR 0.50; 99 % CI, 0.23; 1.06, p = 0.016) but not in the MK−, MK+, and MK1 subgroups. OS was not improved by DAC in any subgroup. In conclusion, we demonstrate for the first time in a randomized phase III trial that high-risk MDS patients with complex karyotypes harboring two or more autosomal monosomies attain encouraging responses and have improved PFS with DAC treatment compared to BSC. More... »

PAGES

191-199

References to SciGraph publications

Journal

TITLE

Annals of Hematology

ISSUE

2

VOLUME

95

Author Affiliations

  • Division of Hematology, Oncology and Stem Cell Transplantation, University of Freiburg Medical Center, Freiburg, Germany
  • European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium
  • Department of Human Genetics, University Hospital, University of Leuven, Leuven, Belgium
  • Department of Hematology and Oncology, University of Dresden, Dresden, Germany
  • Department of Hematology and Oncology, Marienhospital, Düsseldorf, Germany
  • Department of Hematology, AZ Sint-Jan Brugge-Oostende, Brugge, Belgium
  • University Hospital Center Rebro, Zagreb, Croatia
  • Department of Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University, Düsseldorf, Germany
  • Department of Hematology/Oncology, Eberhard Karls University, Tübingen, Germany
  • Department of Hematology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  • Department of Medicine II, DIAKO Bremen, Bremen, Germany
  • Institute of Pathology, University of Freiburg, Freiburg, Germany
  • Institute for Medical Biometry and Medical Informatics, University of Freiburg, Freiburg, Germany
  • Hematology, Oncology, and Clinical Immunology, St Johannes Hospital, Duisburg, Germany
  • Department of Tumor Immunology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  • Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
  • Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands
  • C.H.U. Sart-Tilman, Liège, Belgium
  • UPMC, UMRS 872 and Saint-Antoine Hospital, AP-HP, Paris, France
  • Department of Hematology, Haga Hospital, The Hague, The Netherlands
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00277-015-2547-0

    DOI

    http://dx.doi.org/10.1007/s00277-015-2547-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1016094284

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/26596971


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