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000130491 1001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard$$b0$$eFirst author$$udkfz
000130491 245__ $$aAll-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study.
000130491 260__ $$aBerlin$$bSpringer61936$$c2016
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000130491 520__ $$aThe 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).
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000130491 650_7 $$05688UTC01R$$2NLM Chemicals$$aTretinoin
000130491 7001_ $$aLübbert, Michael$$b1
000130491 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b2$$udkfz
000130491 7001_ $$aLamparter, Alexander$$b3
000130491 7001_ $$aKrauter, Jürgen$$b4
000130491 7001_ $$aHerr, Wolfgang$$b5
000130491 7001_ $$aMartin, Hans$$b6
000130491 7001_ $$aSalih, Helmut R$$b7
000130491 7001_ $$aKündgen, Andrea$$b8
000130491 7001_ $$aHorst, Heinz-A$$b9
000130491 7001_ $$aBrossart, Peter$$b10
000130491 7001_ $$aGötze, Katharina$$b11
000130491 7001_ $$aNachbaur, David$$b12
000130491 7001_ $$aWattad, Mohammed$$b13
000130491 7001_ $$aKöhne, Claus-Henning$$b14
000130491 7001_ $$aFiedler, Walter$$b15
000130491 7001_ $$aBentz, Martin$$b16
000130491 7001_ $$aWulf, Gerald$$b17
000130491 7001_ $$aHeld, Gerhard$$b18
000130491 7001_ $$aHertenstein, Bernd$$b19
000130491 7001_ $$aSalwender, Hans$$b20
000130491 7001_ $$aGaidzik, Verena I$$b21
000130491 7001_ $$aSchlegelberger, Brigitte$$b22
000130491 7001_ $$aWeber, Daniela$$b23
000130491 7001_ $$aDöhner, Konstanze$$b24
000130491 7001_ $$aGanser, Arnold$$b25
000130491 7001_ $$aDöhner, Hartmut$$b26
000130491 7001_ $$aGroup, German-Austrian Acute Myeloid Leukemia Study$$b27$$eCollaboration Author
000130491 77318 $$2Crossref$$3journal-article$$a10.1007/s00277-016-2810-z$$bSpringer Science and Business Media LLC$$d2016-10-03$$n12$$p1931-1942$$tAnnals of Hematology$$v95$$x0939-5555$$y2016
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