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000143062 0247_ $$2ISSN$$a1528-0020
000143062 0247_ $$2ISSN$$a1938-1336
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000143062 1001_ $$0P:(DE-He78)d8a0e60e5e095f3161ee0de3712409bc$$aSchlenk, Richard$$b0
000143062 245__ $$aMidostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD.
000143062 260__ $$aStanford, Calif.$$bHighWire Press$$c2019
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000143062 520__ $$aPatients with acute myeloid leukemia (AML) and a FLT3 internal tandem duplication (ITD) have poor outcomes to current treatment. A phase 2 hypothesis-generating trial was conducted to determine whether the addition of the multitargeted kinase inhibitor midostaurin to intensive chemotherapy followed by allogeneic hematopoietic cell transplantation (alloHCT) and single-agent maintenance therapy of 12 months is feasible and favorably influences event-free survival (EFS) compared with historical controls. Patients 18 to 70 years of age with newly diagnosed AML and centrally confirmed FLT3-ITD were eligible: 284 patients were treated, including 198 younger (18-60 years) and 86 older (61-70 years) patients. Complete remission (CR) rate, including CR with incomplete hematological recovery (CRi) after induction therapy, was 76.4% (younger, 75.8%; older, 77.9%). The majority of patients in CR/CRi proceeded to alloHCT (72.4%). Maintenance therapy was started in 97 patients (34%): 75 after alloHCT and 22 after consolidation with high-dose cytarabine (HiDAC). Median time receiving maintenance therapy was 9 months after alloHCT and 10.5 months after HiDAC; premature termination was mainly a result of nonrelapse causes (gastrointestinal toxicity and infections). EFS and overall survival at 2 years were 39% (95% confidence interval [CI], 33%-47%) and 34% (95% CI, 24%-47%) and 53% (95% CI, 46%-61%) and 46% (95% CI, 35%-59%) in younger and older patients, respectively. EFS was evaluated in comparison with 415 historical controls treated within 5 prospective trials. Propensity score-weighted analysis revealed a significant improvement of EFS by midostaurin (hazard ratio [HR], 0.58; 95% CI, 0.48-0.70; P < .001) overall and in older patients (HR, 0.42; 95% CI, 0.29-0.61). The study was registered at www.clinicaltrials.gov as #NCT01477606.
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000143062 7001_ $$aWeber, Daniela$$b1
000143062 7001_ $$aFiedler, Walter$$b2
000143062 7001_ $$aSalih, Helmut R$$b3
000143062 7001_ $$aWulf, Gerald$$b4
000143062 7001_ $$aSalwender, Hans$$b5
000143062 7001_ $$aSchroeder, Thomas$$b6
000143062 7001_ $$aKindler, Thomas$$b7
000143062 7001_ $$aLübbert, Michael$$b8
000143062 7001_ $$aWolf, Dominik$$b9
000143062 7001_ $$aWestermann, Jörg$$b10
000143062 7001_ $$aKraemer, Doris$$b11
000143062 7001_ $$00000-0002-6276-8002$$aGötze, Katharina S$$b12
000143062 7001_ $$aHorst, Heinz-August$$b13
000143062 7001_ $$aKrauter, Jürgen$$b14
000143062 7001_ $$aGirschikofsky, Michael$$b15
000143062 7001_ $$aRinghoffer, Mark$$b16
000143062 7001_ $$aSüdhoff, Thomas$$b17
000143062 7001_ $$aHeld, Gerhard$$b18
000143062 7001_ $$aDerigs, Hans-Günter$$b19
000143062 7001_ $$aSchroers, Roland$$b20
000143062 7001_ $$aGreil, Richard$$b21
000143062 7001_ $$aGrießhammer, Martin$$b22
000143062 7001_ $$aLange, Elisabeth$$b23
000143062 7001_ $$aBurchardt, Alexander$$b24
000143062 7001_ $$aMartens, Uwe$$b25
000143062 7001_ $$aHertenstein, Bernd$$b26
000143062 7001_ $$aMarretta, Lore$$b27
000143062 7001_ $$aHeuser, Michael$$b28
000143062 7001_ $$aThol, Felicitas$$b29
000143062 7001_ $$aGaidzik, Verena I$$b30
000143062 7001_ $$aHerr, Wolfgang$$b31
000143062 7001_ $$0P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9$$aKrzykalla, Julia$$b32
000143062 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b33
000143062 7001_ $$aDöhner, Konstanze$$b34
000143062 7001_ $$aGanser, Arnold$$b35
000143062 7001_ $$aPaschka, Peter$$b36
000143062 7001_ $$aDöhner, Hartmut$$b37
000143062 7001_ $$aGroup, German-Austrian AML Study$$b38$$eCollaboration Author
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