Valproate and Retinoic Acid in Combination With Decitabine in Elderly Nonfit Patients With Acute Myeloid Leukemia: Results of a Multicenter, Randomized, 2 × 2, Phase II Trial.


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
20 01 2020
Historique:
pubmed: 4 12 2019
medline: 1 7 2020
entrez: 4 12 2019
Statut: ppublish

Résumé

DNA-hypomethylating agents are studied in combination with other epigenetic drugs, such as histone deacetylase inhibitors or differentiation inducers (eg, retinoids), in myeloid neoplasias. A randomized, phase II trial with a 2 × 2 factorial design was conducted to investigate the effects of the histone deacetylase inhibitor valproate and all- Two hundred patients (median age, 76 years; range, 61-92 years) ineligible for induction chemotherapy received decitabine (20 mg/m The addition of ATRA resulted in a higher remission rate (21.9% with ATRA The addition of ATRA to decitabine resulted in a higher remission rate and a clinically meaningful survival extension in these patients with difficult-to-treat disease, without added toxicity.

Identifiants

pubmed: 31794324
doi: 10.1200/JCO.19.01053
doi:

Substances chimiques

Tretinoin 5688UTC01R
Valproic Acid 614OI1Z5WI
Decitabine 776B62CQ27

Banques de données

ClinicalTrials.gov
['NCT00867672']

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

257-270

Auteurs

Michael Lübbert (M)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Freiburg, Germany.

Olga Grishina (O)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Claudia Schmoor (C)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Richard F Schlenk (RF)

University Hospital of Ulm, Ulm, Germany.
Heidelberg University Hospital, Heidelberg, Germany.

Edgar Jost (E)

University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.

Martina Crysandt (M)

University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.

Michael Heuser (M)

Hannover Medical School, Hannover, Germany.

Felicitas Thol (F)

Hannover Medical School, Hannover, Germany.

Helmut R Salih (HR)

German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Tübingen, Germany.

Marcus M Schittenhelm (MM)

Eberhard-Karls-University, Tübingen, Germany.

Ulrich Germing (U)

Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.

Andrea Kuendgen (A)

Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Düsseldorf, Germany.

Katharina S Götze (KS)

Technical University of Munich, Munich, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Munich, Germany.

Hans-Walter Lindemann (HW)

Catholic Hospital, Hagen, Germany.

Carsten Müller-Tidow (C)

Heidelberg University Hospital, Heidelberg, Germany.
University Hospital of Münster, Münster, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Heidelberg, Germany.

Gerhard Heil (G)

Klinikum Lüdenscheid, Lüdenscheid, Germany.

Sebastian Scholl (S)

Universitätsklinikum Jena, Jena, Germany.

Gesine Bug (G)

University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Frankfurt, Germany.

Carsten Schwaenen (C)

Hospital Esslingen, Esslingen, Germany.
Offenburg Hospital, Offenburg, Germany.

Aristoteles Giagounidis (A)

Marien-Hospital Düsseldorf, Düsseldorf, Germany.

Andreas Neubauer (A)

University Clinic Gießen/Marburg, Marburg, Germany.

Jürgen Krauter (J)

Städtisches Klinikum Braunschweig, Braunschweig, Germany.

Wolfram Brugger (W)

Hospital Villingen-Schwenningen, Villingen-Schwenningen, Germany.

Maike De Wit (M)

Vivantes Klinikum Neukoelln, Berlin, Germany.

Ralph Wäsch (R)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Heiko Becker (H)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Freiburg, Germany.

Annette M May (AM)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Justus Duyster (J)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Freiburg, Germany.

Konstanze Döhner (K)

University Hospital of Ulm, Ulm, Germany.

Arnold Ganser (A)

Hannover Medical School, Hannover, Germany.

Björn Hackanson (B)

Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Universitätsklinikum Augsburg, Augsburg, Germany.

Hartmut Döhner (H)

University Hospital of Ulm, Ulm, Germany.

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Classifications MeSH