Journal Article

DKFZ-2018-01221

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial.

Paschka, P. ; Schlenk, R. F. ; Weber, D. ; Benner, A.DKFZ* ; Bullinger, L. ; Heuser, M. ; Gaidzik, V. I. ; Thol, F. ; Agrawal, M. ; Teleanu, V. ; Lübbert, M. ; Fiedler, W. ; Radsak, M. ; Krauter, J. ; Horst, H.-A. ; Greil, R. ; Mayer, K. ; Kündgen, A. ; Martens, U. ; Heil, G. ; Salih, H. R. ; Hertenstein, B. ; Schwänen, C. ; Wulf, G. ; Lange, E. ; Pfreundschuh, M. ; Ringhoffer, M. ; Girschikofsky, M. ; Heinicke, T. ; Kraemer, D. ; Göhring, G. ; Ganser, A. ; Döhner, K. ; Döhner, H.

2018
Nature Publ. Group Basingstoke

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Please use a persistent id in citations: doi:10.1038/s41375-018-0129-6

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).

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Contributing Institute(s):

1. Biostatistik (C060)

Research Program(s):

1. 313 - Cancer risk factors and prevention (POF3-313) (POF3-313)

Appears in the scientific report 2018

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Database coverage:
; BIOSIS Previews ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 10 ; 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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