Journal Article

DKFZ-2017-05570

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study.

Schlenk, R. (First author)DKFZ* ; Lübbert, M. ; Benner, A.DKFZ* ; Lamparter, A. ; Krauter, J. ; Herr, W. ; Martin, H. ; Salih, H. R. ; Kündgen, A. ; Horst, H.-A. ; Brossart, P. ; Götze, K. ; Nachbaur, D. ; Wattad, M. ; Köhne, C.-H. ; Fiedler, W. ; Bentz, M. ; Wulf, G. ; Held, G. ; Hertenstein, B. ; Salwender, H. ; Gaidzik, V. I. ; Schlegelberger, B. ; Weber, D. ; Döhner, K. ; Ganser, A. ; Döhner, H. ; Group, G. A. M. L. S. (Collaboration Author)

2016
Springer61936 Berlin

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Please use a persistent id in citations: doi:10.1007/s00277-016-2810-z

Abstract: The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).

Keyword(s): Tretinoin

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Contributing Institute(s):

1. Klinische Studienzentrale (G040)
2. Biostatistik (C060)
3. Translationale Onkologie (G100)

Research Program(s):

1. 317 - Translational cancer research (POF3-317) (POF3-317)

Appears in the scientific report 2016

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Database coverage:
; BIOSIS Previews ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF < 5 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Thomson Reuters Master Journal List ; Web of Science Core Collection

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