Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-02-06

AUTHORS

R. F. Schlenk, D. Weber, W. Herr, G. Wulf, H. R. Salih, H. G. Derigs, A. Kuendgen, M. Ringhoffer, B. Hertenstein, U. M. Martens, M. Grießhammer, H. Bernhard, J. Krauter, M. Girschikofsky, D. Wolf, E. Lange, J. Westermann, E. Koller, S. Kremers, M. Wattad, M. Heuser, F. Thol, G. Göhring, D. Haase, V. Teleanu, V. Gaidzik, A. Benner, K. Döhner, A. Ganser, P. Paschka, H. Döhner

ABSTRACT

The aim of this randomized phase-II study was to evaluate the effect of substituting cytarabine by azacitidine in intensive induction therapy of patients with acute myeloid leukemia (AML). Patients were randomized to four induction schedules for two cycles: STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide. Consolidation therapy consisted of allogeneic hematopoietic-cell transplantation or three courses of high-dose cytarabine followed by 2-year maintenance therapy with azacitidine in the azacitidine-arms. AML with CBFB-MYH11, RUNX1-RUNX1T1, mutated NPM1, and FLT3-ITD were excluded and accrued to genotype-specific trials. The primary end point was response to induction therapy. The statistical design was based on an optimal two-stage design applied for each arm separately. During the first stage, 104 patients (median age 62.6, range 18–82 years) were randomized; the study arms PRIOR and CONCURRENT were terminated early due to inefficacy. After randomization of 268 patients, all azacitidine-containing arms showed inferior response rates compared to STANDARD. Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively). The data from this trial do not support the substitution of cytarabine by azacitidine in intensive induction therapy. More... »

PAGES

1923-1933

References to SciGraph publications

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  • Journal

    TITLE

    Leukemia

    ISSUE

    8

    VOLUME

    33

    Author Affiliations

  • Department of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany
  • Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany
  • Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany
  • Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany
  • Department of Hematology and Oncology, Eberhard-Karls University, Tübingen, Germany
  • Department of Internal Medicine III, Hospital Frankfurt-Hoechst, Frankfurt, Germany
  • Department of Hematology, Oncology and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany
  • Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany
  • Department of Hematology and Oncology, Klinikum am Gesundbrunnen, Heilbronn, Germany
  • Department of Hematology and Oncology, University Hospital of Minden, Minden, Germany
  • Department of Hematology and Oncology, Darmstadt, Municipal Hospital, Darmstadt, Germany
  • Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany
  • Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria
  • Department of Internal Medicine V, Medical University Innsbruck, Innsbruck, Austria
  • Department of Hematology and Oncology, Evangelisches Krankenhaus Hamm, Hamm, Germany
  • Department of Hematology, Oncology and Tumor Immunology, Charité - Campus Virchow Clinic, Berlin, Germany
  • Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria
  • Department of Internal Medicine, Caritas-Krankenhaus Lebach, Lebach, Germany
  • Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany
  • Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
  • Institute of Human Genetics, Hannover Medical School, Hannover, Germany
  • Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41375-019-0395-y

    DOI

    http://dx.doi.org/10.1038/s41375-019-0395-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1111950346

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30728457


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