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000157548 1001_ $$aKapp-Schwoerer, Silke$$b0
000157548 245__ $$aImpact of gemtuzumab ozogamicin on MRD and relapse risk in NPM1 mutated AML patients: results from the AMLSG 09-09 Trial.
000157548 260__ $$aStanford, Calif.$$bHighWire Press$$c2020
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000157548 500__ $$a2020 Dec 24;136(26):3041-3050
000157548 520__ $$aMonitoring of measurable residual disease (MRD) provides prognostic information in patients with Nucleophosmin1 mutated (NPM1mut) acute myeloid leukemia (AML) and represents a powerful tool to evaluate treatment effects within clinical trials. We determined NPM1mut transcript levels (TL) by RQ-PCR and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TL and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase III AMLSG 09-09 trial. 3733 bone marrow (BM) and 3793 peripheral blood (PB) samples from 469 patients were analyzed. NPM1mut TL log10 reduction ≥3 and achievement of MRD negativity in BM and PB were significantly associated with a lower CIR rate, after two treatment cycles and at end of treatment (EOT). In multivariate analyses, MRD positivity consistently revealed as poor prognostic factor in BM and PB. With regard to treatment effect, the median NPM1mut TL were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly higher proportion of patients achieving MRD negativity at EOT (56% vs 41%; P=.01). The betterreduction of NPM1mut TL after two treatment cycles in MRD-positive patients by the addition of GO led to a significantly lower CIR rate (4-year CIR 29.3% vs 45.7%, P=.009). In conclusion, the addition of GO to intensive chemotherapy in NPM1mut AML resulted in a significantly better reduction of NPM1mut TL across all treatment cycles leading to a significantly lower relapse rate. The AMLSG 09-09 trial was registered at www.clinicaltrials.gov as #NCT00893399.
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000157548 7001_ $$aWeber, Daniela$$b1
000157548 7001_ $$aCorbacioglu, Andrea$$b2
000157548 7001_ $$aGaidzik, Verena I$$b3
000157548 7001_ $$aPaschka, Peter$$b4
000157548 7001_ $$aKrönke, Jan$$b5
000157548 7001_ $$aTheis, Frauke$$b6
000157548 7001_ $$aRücker, Frank G$$b7
000157548 7001_ $$0P:(DE-He78)4e4e534b615747750de8b9a7afdd8f56$$aTeleanu, Maria-Veronica$$b8$$udkfz
000157548 7001_ $$aPanina, Ekaterina$$b9
000157548 7001_ $$aJahn, Nikolaus$$b10
000157548 7001_ $$aHerzig, Julia K$$b11
000157548 7001_ $$aKubanek, Lena$$b12
000157548 7001_ $$aSchrade, Anika$$b13
000157548 7001_ $$aGohring, Gudrun$$b14
000157548 7001_ $$aFiedler, Walter$$b15
000157548 7001_ $$aKindler, Thomas$$b16
000157548 7001_ $$aSchroeder, Thomas$$b17
000157548 7001_ $$aMayer, Karin$$b18
000157548 7001_ $$aLübbert, Michael$$b19
000157548 7001_ $$aWattad, Mohammed$$b20
000157548 7001_ $$aGötze, Katharina$$b21
000157548 7001_ $$aHorst, Heinz A$$b22
000157548 7001_ $$aKoller, Elisabeth$$b23
000157548 7001_ $$aWulf, Gerald G$$b24
000157548 7001_ $$aSchleicher, Jan$$b25
000157548 7001_ $$aBentz, Martin$$b26
000157548 7001_ $$aKrauter, Jürgen$$b27
000157548 7001_ $$aBullinger, Lars$$b28
000157548 7001_ $$0P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9$$aKrzykalla, Julia$$b29
000157548 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b30
000157548 7001_ $$aSchlenk, Richard F$$b31
000157548 7001_ $$aThol, Felicitas$$b32
000157548 7001_ $$aHeuser, Michael$$b33
000157548 7001_ $$aGanser, Arnold$$b34
000157548 7001_ $$aDöhner, Hartmut$$b35
000157548 7001_ $$aDöhner, Konstanze$$b36
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