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000179738 1001_ $$00000-0003-2116-5536$$aDöhner, Hartmut$$b0
000179738 245__ $$aMidostaurin plus intensive chemotherapy for younger and older Patients with AML and FLT3 internal tandem duplications.
000179738 260__ $$aWashington, DC$$bAmerican Society of Hematology$$c2022
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000179738 500__ $$a2022 Sep 27;6(18):5345-5355
000179738 520__ $$aWe conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3 internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD.
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000179738 7001_ $$aWeber, Daniela$$b1
000179738 7001_ $$0P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9$$aKrzykalla, Julia$$b2
000179738 7001_ $$aFiedler, Walter$$b3
000179738 7001_ $$aWulf, Gerald Georg$$b4
000179738 7001_ $$aSalih, Helmut R$$b5
000179738 7001_ $$aLübbert, Michael$$b6
000179738 7001_ $$aKühn, Michael$$b7
000179738 7001_ $$aSchroeder, Thomas$$b8
000179738 7001_ $$aSalwender, Hans$$b9
000179738 7001_ $$00000-0002-6276-8002$$aGötze, Katharina S$$b10
000179738 7001_ $$aWestermann, Jörg$$b11
000179738 7001_ $$00000-0002-3658-0284$$aFransecky, Lars$$b12
000179738 7001_ $$aMayer, Karin$$b13
000179738 7001_ $$aHertenstein, Bernd$$b14
000179738 7001_ $$aRinghoffer, Mark$$b15
000179738 7001_ $$aTischler, Hans-Joachim$$b16
000179738 7001_ $$aMachherndl-Spandl, Sigrid$$b17
000179738 7001_ $$aSchrade, Anika$$b18
000179738 7001_ $$aPaschka, Peter$$b19
000179738 7001_ $$aGaidzik, Verena I$$b20
000179738 7001_ $$aTheis, Frauke$$b21
000179738 7001_ $$aThol, Felicitas R$$b22
000179738 7001_ $$aHeuser, Michael$$b23
000179738 7001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard F$$b24$$udkfz
000179738 7001_ $$aBullinger, Lars$$b25
000179738 7001_ $$aSaadati, Maral$$b26
000179738 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b27
000179738 7001_ $$00000-0001-9168-3203$$aLarson, Richard A$$b28
000179738 7001_ $$aStone, Richard M$$b29
000179738 7001_ $$aDöhner, Konstanze$$b30
000179738 7001_ $$00000-0003-3510-4304$$aGanser, Arnold$$b31
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