Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial

Item Type:	Article
Title:	Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial
Creators Name:	Paschka, P. and Schlenk, R.F. and Weber, D. and Benner, A. and Bullinger, L. and Heuser, M. and Gaidzik, V.I. and Thol, F. and Agrawal, M. and Teleanu, V. and Lübbert, M. and Fiedler, W. and Radsak, M. and Krauter, J. and Horst, H.A. and Greil, R. and Mayer, K. and Kündgen, A. and Martens, U. and Heil, G. and Salih, H.R. and Hertenstein, B. and Schwänen, C. and Wulf, G. and Lange, E. and Pfreundschuh, M. and Ringhoffer, M. and Girschikofsky, M. and Heinicke, T. and Kraemer, D. and Göhring, G. and Ganser, A. and Döhner, K. and Döhner, H.
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).
Keywords:	Acute Myeloid Leukemia, Molecularly Targeted Therapy
Source:	Leukemia
ISSN:	1476-5551
Publisher:	Nature Publishing Group
Volume:	32
Number:	7
Page Range:	1621-1630
Date:	July 2018
Official Publication:	https://doi.org/10.1038/s41375-018-0129-6
PubMed:	View item in PubMed

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