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000154483 0247_ $$2doi$$a10.1200/JCO.19.01406
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000154483 037__ $$aDKFZ-2020-00805
000154483 041__ $$aeng
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000154483 1001_ $$aSchlenk, Richard F$$b0
000154483 245__ $$aGemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study.
000154483 260__ $$aAlexandria, Va.$$bAmerican Society of Clinical Oncology$$c2020
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000154483 520__ $$aHigh CD33 expression in acute myeloid leukemia (AML) with mutated NPM1 provides a rationale for the evaluation of gemtuzumab ozogamicin (GO) in this AML entity. We conducted a randomized trial to evaluate GO in combination with intensive induction and consolidation therapy in NPM1-mutated AML.Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy were randomly assigned up front for induction therapy with idarubicin, cytarabine, etoposide, and all-trans-retinoic acid with or without GO. The early (P = .02) primary end point of event-free survival (EFS) was evaluated 6 months after completion of patient recruitment.Five hundred eighty-eight patients were randomly assigned (standard arm, n = 296; GO arm, n = 292). EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04; P = .10). The early death rate during induction therapy was 10.3% in the GO arm and 5.7% in the standard arm (P = .05). Causes of death in both arms were mainly infections. The cumulative incidence of relapse (CIR) in patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi) was significantly reduced in the GO arm compared with the standard arm (P = .005), with no difference in the cumulative incidence of death (P = .80). Subgroup analysis revealed a significant beneficial effect of GO in female, younger (≤ 70 years), and FLT3 internal tandem duplication-negative patients with respect to EFS and CIR.The trial did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. However, in patients achieving CR/CRi after induction therapy, significantly fewer relapses occurred in the GO compared with the standard arm.
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000154483 7001_ $$aPaschka, Peter$$b1
000154483 7001_ $$0P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9$$aKrzykalla, Julia$$b2$$udkfz
000154483 7001_ $$aWeber, Daniela$$b3
000154483 7001_ $$aKapp-Schwoerer, Silke$$b4
000154483 7001_ $$aGaidzik, Verena I$$b5
000154483 7001_ $$aLeis, Claudia$$b6
000154483 7001_ $$aFiedler, Walter$$b7
000154483 7001_ $$aKindler, Thomas$$b8
000154483 7001_ $$aSchroeder, Thomas$$b9
000154483 7001_ $$aMayer, Karin$$b10
000154483 7001_ $$aLübbert, Michael$$b11
000154483 7001_ $$aWattad, Mohammed$$b12
000154483 7001_ $$aGötze, Katharina$$b13
000154483 7001_ $$aHorst, Heinz A$$b14
000154483 7001_ $$aKoller, Elisabeth$$b15
000154483 7001_ $$aWulf, Gerald$$b16
000154483 7001_ $$aSchleicher, Jan$$b17
000154483 7001_ $$aBentz, Martin$$b18
000154483 7001_ $$aGreil, Richard$$b19
000154483 7001_ $$aHertenstein, Bernd$$b20
000154483 7001_ $$aKrauter, Jürgen$$b21
000154483 7001_ $$aMartens, Uwe$$b22
000154483 7001_ $$aNachbaur, David$$b23
000154483 7001_ $$aAbu Samra, Maisun$$b24
000154483 7001_ $$aGirschikofsky, Michael$$b25
000154483 7001_ $$aBasara, Nadezda$$b26
000154483 7001_ $$aBenner, Axel$$b27
000154483 7001_ $$aThol, Felicitas$$b28
000154483 7001_ $$aHeuser, Michael$$b29
000154483 7001_ $$aGanser, Arnold$$b30
000154483 7001_ $$aDöhner, Konstanze$$b31
000154483 7001_ $$aDöhner, Hartmut$$b32
000154483 773__ $$0PERI:(DE-600)2005181-5$$a10.1200/JCO.19.01406$$gVol. 38, no. 6, p. 623 - 632$$n6$$p623 - 632$$tJournal of clinical oncology$$v38$$x1527-7755$$y2020
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