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All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study

Standard

All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. / Schlenk, Richard F; Lübbert, Michael; Benner, Axel; Lamparter, Alexander; Krauter, Jürgen; Herr, Wolfgang; Martin, Hans; Salih, Helmut R; Kündgen, Andrea; Horst, Heinz-A; Brossart, Peter; Götze, Katharina; Nachbaur, David; Wattad, Mohammed; Köhne, Claus-Henning; Fiedler, Walter; Bentz, Martin; Wulf, Gerald; Held, Gerhard; Hertenstein, Bernd; Salwender, Hans; Gaidzik, Verena I; Schlegelberger, Brigitte; Weber, Daniela; Döhner, Konstanze; Ganser, Arnold; Döhner, Hartmut; German-Austrian Acute Myeloid Leukemia Study Group.

in: ANN HEMATOL, Jahrgang 95, Nr. 12, 01.12.2016, S. 1931-1942.

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

Harvard

Schlenk, RF, Lübbert, M, Benner, A, Lamparter, A, Krauter, J, Herr, W, Martin, H, Salih, HR, Kündgen, A, Horst, H-A, Brossart, P, Götze, K, Nachbaur, D, Wattad, M, Köhne, C-H, Fiedler, W, Bentz, M, Wulf, G, Held, G, Hertenstein, B, Salwender, H, Gaidzik, VI, Schlegelberger, B, Weber, D, Döhner, K, Ganser, A, Döhner, H & German-Austrian Acute Myeloid Leukemia Study Group 2016, 'All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study', ANN HEMATOL, Jg. 95, Nr. 12, S. 1931-1942. https://doi.org/10.1007/s00277-016-2810-z

APA

Schlenk, R. F., Lübbert, M., Benner, A., Lamparter, A., Krauter, J., Herr, W., Martin, H., Salih, H. R., Kündgen, A., Horst, H-A., Brossart, P., Götze, K., Nachbaur, D., Wattad, M., Köhne, C-H., Fiedler, W., Bentz, M., Wulf, G., Held, G., ... German-Austrian Acute Myeloid Leukemia Study Group (2016). All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. ANN HEMATOL, 95(12), 1931-1942. https://doi.org/10.1007/s00277-016-2810-z

Vancouver

Schlenk RF, Lübbert M, Benner A, Lamparter A, Krauter J, Herr W et al. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. ANN HEMATOL. 2016 Dez 1;95(12):1931-1942. https://doi.org/10.1007/s00277-016-2810-z

Bibtex

@article{5359827725604b998ff73785e6d9bc4b,
title = "All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study",
abstract = "The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).",
author = "Schlenk, {Richard F} and Michael L{\"u}bbert and Axel Benner and Alexander Lamparter and J{\"u}rgen Krauter and Wolfgang Herr and Hans Martin and Salih, {Helmut R} and Andrea K{\"u}ndgen and Heinz-A Horst and Peter Brossart and Katharina G{\"o}tze and David Nachbaur and Mohammed Wattad and Claus-Henning K{\"o}hne and Walter Fiedler and Martin Bentz and Gerald Wulf and Gerhard Held and Bernd Hertenstein and Hans Salwender and Gaidzik, {Verena I} and Brigitte Schlegelberger and Daniela Weber and Konstanze D{\"o}hner and Arnold Ganser and Hartmut D{\"o}hner and {German-Austrian Acute Myeloid Leukemia Study Group}",
year = "2016",
month = dec,
day = "1",
doi = "10.1007/s00277-016-2810-z",
language = "English",
volume = "95",
pages = "1931--1942",
journal = "ANN HEMATOL",
issn = "0939-5555",
publisher = "Springer",
number = "12",

}

RIS

TY - JOUR

T1 - All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study

AU - Schlenk, Richard F

AU - Lübbert, Michael

AU - Benner, Axel

AU - Lamparter, Alexander

AU - Krauter, Jürgen

AU - Herr, Wolfgang

AU - Martin, Hans

AU - Salih, Helmut R

AU - Kündgen, Andrea

AU - Horst, Heinz-A

AU - Brossart, Peter

AU - Götze, Katharina

AU - Nachbaur, David

AU - Wattad, Mohammed

AU - Köhne, Claus-Henning

AU - Fiedler, Walter

AU - Bentz, Martin

AU - Wulf, Gerald

AU - Held, Gerhard

AU - Hertenstein, Bernd

AU - Salwender, Hans

AU - Gaidzik, Verena I

AU - Schlegelberger, Brigitte

AU - Weber, Daniela

AU - Döhner, Konstanze

AU - Ganser, Arnold

AU - Döhner, Hartmut

AU - German-Austrian Acute Myeloid Leukemia Study Group

PY - 2016/12/1

Y1 - 2016/12/1

N2 - The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).

AB - The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).

U2 - 10.1007/s00277-016-2810-z

DO - 10.1007/s00277-016-2810-z

M3 - SCORING: Journal article

C2 - 27696203

VL - 95

SP - 1931

EP - 1942

JO - ANN HEMATOL

JF - ANN HEMATOL

SN - 0939-5555

IS - 12

ER -