Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia—results of the AMLSG 11-08 trial View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-04-17

AUTHORS

Peter Paschka, Richard F Schlenk, Daniela Weber, Axel Benner, Lars Bullinger, Michael Heuser, Verena I Gaidzik, Felicitas Thol, Mridul Agrawal, Veronica Teleanu, Michael Lübbert, Walter Fiedler, Markus Radsak, Jürgen Krauter, Heinz-A. Horst, Richard Greil, Karin Mayer, Andrea Kündgen, Uwe Martens, Gerhard Heil, Helmut R Salih, Bernd Hertenstein, Carsten Schwänen, Gerald Wulf, Elisabeth Lange, Michael Pfreundschuh, Mark Ringhoffer, Michael Girschikofsky, Thomas Heinicke, Doris Kraemer, Gudrun Göhring, Arnold Ganser, Konstanze Döhner, Hartmut Döhner

ABSTRACT

In this phase Ib/IIa study (ClinicalTrials.gov Identifier: NCT00850382) of the German-Austrian AML Study Group (AMLSG) the multikinase inhibitor dasatinib was added to intensive induction and consolidation chemotherapy and administered as single agent for 1-year maintenance in first-line treatment of adult patients with core-binding factor (CBF) acute myeloid leukemia (AML). The primary combined end point in this study was safety and feasibility, and included the rates of early (ED) and hypoplastic (HD) deaths, pleural/pericardial effusion 3°/4° and liver toxicity 3°/4°, and the rate of refractory disease. Secondary end points were cumulative incidence of relapse (CIR) and death in complete remission (CID), and overall survival (OS). Eighty-nine pts [median age 49.5 years, range: 19–73 years; t(8;21), n = 37; inv (16), n = 52] were included. No unexpected excess in toxicity was observed. The rates of ED/HD and CR/CRi were 4.5% (4/89) and 94% (84/89), respectively. The 4-year estimated CIR, CID, and OS were 33.1% [95%-CI (confidence interval), 22.7–43.4%], 6.0% (95% CI, 0.9–11.2%), and 74.7% (95% CI, 66.1–84.5%), respectively. On the basis of the acceptable toxicity profile and favorable outcome in the AMLSG 11–08 trial, a confirmatory randomized phase III trial with dasatinib in adults with CBF-AML is ongoing (ClinicalTrials.gov Identifier: NCT02013648). More... »

PAGES

1621-1630

Journal

TITLE

Leukemia

ISSUE

7

VOLUME

32

Author Affiliations

  • Klinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany
  • Abteilung Biostatistik, Deutsches Krebsforschungszentrum, Heidelberg, Germany
  • Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany
  • Klinik für Innere Medizin I, Medizinische Fakultät, Universitätsklinikum Freiburg, Freiburg, Germany
  • II. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
  • III. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz, Mainz, Germany
  • Medizinische Klinik III, Klinikum Braunschweig, Braunschweig, Germany
  • Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
  • 3. III. Medizinische Universitätsklinik, Paracelsus Medizinische Privatuniversität Salzburg, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Salzburg, Austria
  • Medizinische Klinik und Poliklinik III, Universitätsklinikum Bonn, Bonn, Germany
  • Klinik für Hämatologie, Onkologie und Klinische Immunologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany
  • Klinik für Innere Medizin III, SLK-Kliniken Heilbronn GmbH, Heilbronn, Germany
  • Innere Medizin V, Märkische Kliniken, Klinikum Lüdenscheid, Lüdenscheid, Germany
  • Innere Medizin II, Medizinische Klinik, Universitätsklinikum Tübingen, Tübingen, Germany
  • Medizinische Klinik I, Klinikum Bremen-Mitte, Bremen, Germany
  • Klinik für Allgemeine Innere Medizin, Onkologie/Hämatologie, Gastroenterologie und Infektiologie, Klinikum Esslingen GmbH, Esslingen, Germany
  • Klinik für Hämatologie und Medizinische Onkologie, Universitätsmedizin Göttingen, Göttingen, Germany
  • Klinik für Hämatologie, Onkologie und Palliativmedizin, Evangelisches Krankenhaus Hamm, Hamm, Germany
  • Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany
  • Medizinische Klinik III, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany
  • Interne 1—Hämato-Onkologie, Krankenhaus der Elisabethinen Linz, Linz, Austria
  • Klinik für Hämatologie und Onkologie, Universitätsklinikum Magdeburg, Magdeburg, Germany
  • Klinik für Onkologie und Hämatologie, Klinikum Oldenburg, Oldenburg, Germany
  • Institut für Humangenetik, Medizinische Hochschule Hannover, Hannover, Germany
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41375-018-0129-6

    DOI

    http://dx.doi.org/10.1038/s41375-018-0129-6

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1103532578

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29720733


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