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Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial

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Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial. / Kapp-Schwoerer, Silke; Weber, Daniela; Corbacioglu, Andrea; Gaidzik, Verena I; Paschka, Peter; Krönke, Jan; Theis, Frauke; Rücker, Frank G; Teleanu, Maria-Veronica; Panina, Ekaterina; Jahn, Nikolaus; Herzig, Julia; Kubanek, Lena; Schrade, Anika; Göhring, Gudrun; Fiedler, Walter; Kindler, Thomas; Schroeder, Thomas; Mayer, Karin T; Lübbert, Michael; Wattad, Mohammed; Götze, Katharina S; Horst, Heinz A; Koller, Elisabeth; Wulf, Gerald; Schleicher, Jan; Bentz, Martin; Krauter, Jürgen; Bullinger, Lars; Krzykalla, Julia; Benner, Axel; Schlenk, Richard F; Thol, Felicitas; Heuser, Michael; Ganser, Arnold; Döhner, Hartmut; Döhner, Konstanze.

in: BLOOD, Jahrgang 136, Nr. 26, 24.12.2020, S. 3041-3050.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Kapp-Schwoerer, S, Weber, D, Corbacioglu, A, Gaidzik, VI, Paschka, P, Krönke, J, Theis, F, Rücker, FG, Teleanu, M-V, Panina, E, Jahn, N, Herzig, J, Kubanek, L, Schrade, A, Göhring, G, Fiedler, W, Kindler, T, Schroeder, T, Mayer, KT, Lübbert, M, Wattad, M, Götze, KS, Horst, HA, Koller, E, Wulf, G, Schleicher, J, Bentz, M, Krauter, J, Bullinger, L, Krzykalla, J, Benner, A, Schlenk, RF, Thol, F, Heuser, M, Ganser, A, Döhner, H & Döhner, K 2020, 'Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial', BLOOD, Jg. 136, Nr. 26, S. 3041-3050. https://doi.org/10.1182/blood.2020005998, https://doi.org/10.1182/blood.2020005998

APA

Kapp-Schwoerer, S., Weber, D., Corbacioglu, A., Gaidzik, V. I., Paschka, P., Krönke, J., Theis, F., Rücker, F. G., Teleanu, M-V., Panina, E., Jahn, N., Herzig, J., Kubanek, L., Schrade, A., Göhring, G., Fiedler, W., Kindler, T., Schroeder, T., Mayer, K. T., ... Döhner, K. (2020). Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial. BLOOD, 136(26), 3041-3050. https://doi.org/10.1182/blood.2020005998, https://doi.org/10.1182/blood.2020005998

Vancouver

Kapp-Schwoerer S, Weber D, Corbacioglu A, Gaidzik VI, Paschka P, Krönke J et al. Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial. BLOOD. 2020 Dez 24;136(26):3041-3050. https://doi.org/10.1182/blood.2020005998, https://doi.org/10.1182/blood.2020005998

Bibtex

@article{01e1ad3a6230456b8fcc9ceff24d5bea,
title = "Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial",
abstract = "Monitoring 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 (TLs) by quantitative reverse-transcription polymerase chain reaction and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TLs and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase 3 AMLSG 09-09 trial. A total of 3733 bone marrow (BM) samples 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 2 treatment cycles and at end of treatment (EOT). In multivariate analyses, MRD positivity was consistently revealed to be a poor prognostic factor in BM and PB. With regard to treatment effect, the median NPM1mut TLs were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly greater proportion of patients achieving MRD negativity at EOT (56% vs 41%; P = .01). The better reduction in NPM1mut TLs after 2 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 in NPM1mut TLs across all treatment cycles, leading to a significantly lower relapse rate.",
keywords = "Adult, Aged, Aged, 80 and over, Bone Marrow, Disease-Free Survival, Female, Gemtuzumab/administration & dosage, Humans, Leukemia, Myeloid, Acute/drug therapy, Male, Middle Aged, Mutation, Neoplasm Proteins/genetics, Neoplasm, Residual, Nuclear Proteins/genetics, Prospective Studies, Recurrence, Risk Factors, Survival Rate",
author = "Silke Kapp-Schwoerer and Daniela Weber and Andrea Corbacioglu and Gaidzik, {Verena I} and Peter Paschka and Jan Kr{\"o}nke and Frauke Theis and R{\"u}cker, {Frank G} and Maria-Veronica Teleanu and Ekaterina Panina and Nikolaus Jahn and Julia Herzig and Lena Kubanek and Anika Schrade and Gudrun G{\"o}hring and Walter Fiedler and Thomas Kindler and Thomas Schroeder and Mayer, {Karin T} and Michael L{\"u}bbert and Mohammed Wattad and G{\"o}tze, {Katharina S} and Horst, {Heinz A} and Elisabeth Koller and Gerald Wulf and Jan Schleicher and Martin Bentz and J{\"u}rgen Krauter and Lars Bullinger and Julia Krzykalla and Axel Benner and Schlenk, {Richard F} and Felicitas Thol and Michael Heuser and Arnold Ganser and Hartmut D{\"o}hner and Konstanze D{\"o}hner",
note = "{\textcopyright} 2020 by The American Society of Hematology.",
year = "2020",
month = dec,
day = "24",
doi = "10.1182/blood.2020005998",
language = "English",
volume = "136",
pages = "3041--3050",
journal = "BLOOD",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "26",

}

RIS

TY - JOUR

T1 - Impact of gemtuzumab ozogamicin on MRD and relapse risk in patients with NPM1-mutated AML: results from the AMLSG 09-09 trial

AU - Kapp-Schwoerer, Silke

AU - Weber, Daniela

AU - Corbacioglu, Andrea

AU - Gaidzik, Verena I

AU - Paschka, Peter

AU - Krönke, Jan

AU - Theis, Frauke

AU - Rücker, Frank G

AU - Teleanu, Maria-Veronica

AU - Panina, Ekaterina

AU - Jahn, Nikolaus

AU - Herzig, Julia

AU - Kubanek, Lena

AU - Schrade, Anika

AU - Göhring, Gudrun

AU - Fiedler, Walter

AU - Kindler, Thomas

AU - Schroeder, Thomas

AU - Mayer, Karin T

AU - Lübbert, Michael

AU - Wattad, Mohammed

AU - Götze, Katharina S

AU - Horst, Heinz A

AU - Koller, Elisabeth

AU - Wulf, Gerald

AU - Schleicher, Jan

AU - Bentz, Martin

AU - Krauter, Jürgen

AU - Bullinger, Lars

AU - Krzykalla, Julia

AU - Benner, Axel

AU - Schlenk, Richard F

AU - Thol, Felicitas

AU - Heuser, Michael

AU - Ganser, Arnold

AU - Döhner, Hartmut

AU - Döhner, Konstanze

N1 - © 2020 by The American Society of Hematology.

PY - 2020/12/24

Y1 - 2020/12/24

N2 - Monitoring 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 (TLs) by quantitative reverse-transcription polymerase chain reaction and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TLs and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase 3 AMLSG 09-09 trial. A total of 3733 bone marrow (BM) samples 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 2 treatment cycles and at end of treatment (EOT). In multivariate analyses, MRD positivity was consistently revealed to be a poor prognostic factor in BM and PB. With regard to treatment effect, the median NPM1mut TLs were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly greater proportion of patients achieving MRD negativity at EOT (56% vs 41%; P = .01). The better reduction in NPM1mut TLs after 2 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 in NPM1mut TLs across all treatment cycles, leading to a significantly lower relapse rate.

AB - Monitoring 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 (TLs) by quantitative reverse-transcription polymerase chain reaction and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TLs and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase 3 AMLSG 09-09 trial. A total of 3733 bone marrow (BM) samples 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 2 treatment cycles and at end of treatment (EOT). In multivariate analyses, MRD positivity was consistently revealed to be a poor prognostic factor in BM and PB. With regard to treatment effect, the median NPM1mut TLs were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly greater proportion of patients achieving MRD negativity at EOT (56% vs 41%; P = .01). The better reduction in NPM1mut TLs after 2 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 in NPM1mut TLs across all treatment cycles, leading to a significantly lower relapse rate.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Bone Marrow

KW - Disease-Free Survival

KW - Female

KW - Gemtuzumab/administration & dosage

KW - Humans

KW - Leukemia, Myeloid, Acute/drug therapy

KW - Male

KW - Middle Aged

KW - Mutation

KW - Neoplasm Proteins/genetics

KW - Neoplasm, Residual

KW - Nuclear Proteins/genetics

KW - Prospective Studies

KW - Recurrence

KW - Risk Factors

KW - Survival Rate

U2 - 10.1182/blood.2020005998

DO - 10.1182/blood.2020005998

M3 - SCORING: Journal article

C2 - 32812041

VL - 136

SP - 3041

EP - 3050

JO - BLOOD

JF - BLOOD

SN - 0006-4971

IS - 26

ER -