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Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy

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Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. / Döhner, Hartmut; Lübbert, Michael; Fiedler, Walter; Fouillard, Loic; Haaland, Alf; Brandwein, Joseph M; Lepretre, Stephane; Reman, Oumedaly; Turlure, Pascal; Ottmann, Oliver G; Müller-Tidow, Carsten; Krämer, Alwin; Raffoux, Emmanuel; Döhner, Konstanze; Schlenk, Richard F; Voss, Florian; Taube, Tillmann; Fritsch, Holger; Maertens, Johan.

in: BLOOD, Jahrgang 124, Nr. 9, 28.08.2014, S. 1426-33.

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

Harvard

Döhner, H, Lübbert, M, Fiedler, W, Fouillard, L, Haaland, A, Brandwein, JM, Lepretre, S, Reman, O, Turlure, P, Ottmann, OG, Müller-Tidow, C, Krämer, A, Raffoux, E, Döhner, K, Schlenk, RF, Voss, F, Taube, T, Fritsch, H & Maertens, J 2014, 'Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy', BLOOD, Jg. 124, Nr. 9, S. 1426-33. https://doi.org/10.1182/blood-2014-03-560557

APA

Döhner, H., Lübbert, M., Fiedler, W., Fouillard, L., Haaland, A., Brandwein, J. M., Lepretre, S., Reman, O., Turlure, P., Ottmann, O. G., Müller-Tidow, C., Krämer, A., Raffoux, E., Döhner, K., Schlenk, R. F., Voss, F., Taube, T., Fritsch, H., & Maertens, J. (2014). Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. BLOOD, 124(9), 1426-33. https://doi.org/10.1182/blood-2014-03-560557

Vancouver

Döhner H, Lübbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM et al. Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. BLOOD. 2014 Aug 28;124(9):1426-33. https://doi.org/10.1182/blood-2014-03-560557

Bibtex

@article{37db46decadf45eda36399f099f4156b,
title = "Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy",
abstract = "Treatment outcomes for older patients with acute myeloid leukemia (AML) have remained dismal. This randomized, phase 2 trial in AML patients not considered suitable for intensive induction therapy compared low-dose cytarabine (LDAC) with or without volasertib, a highly potent and selective inhibitor of polo-like kinases. Eighty-seven patients (median age 75 years) received LDAC 20 mg twice daily subcutaneously days 1-10 or LDAC + volasertib 350 mg IV days 1 + 15 every 4 weeks. Response rate (complete remission and complete remission with incomplete blood count recovery) was higher for LDAC + volasertib vs LDAC (31.0% vs 13.3%; odds ratio, 2.91; P = .052). Responses in the LDAC + volasertib arm were observed across all genetic groups, including 5 of 14 patients with adverse cytogenetics. Median event-free survival was significantly prolonged by LDAC + volasertib compared with LDAC (5.6 vs 2.3 months; hazard ratio, 0.57; 95% confidence interval, 0.35-0.92; P = .021); median overall survival was 8.0 vs 5.2 months, respectively (hazard ratio, 0.63; 95% confidence interval, 0.40-1.00; P = .047). LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events; there was no increase in the death rate at days 60 + 90. This study was registered at www.clinicaltrials.gov as #NCT00804856.",
author = "Hartmut D{\"o}hner and Michael L{\"u}bbert and Walter Fiedler and Loic Fouillard and Alf Haaland and Brandwein, {Joseph M} and Stephane Lepretre and Oumedaly Reman and Pascal Turlure and Ottmann, {Oliver G} and Carsten M{\"u}ller-Tidow and Alwin Kr{\"a}mer and Emmanuel Raffoux and Konstanze D{\"o}hner and Schlenk, {Richard F} and Florian Voss and Tillmann Taube and Holger Fritsch and Johan Maertens",
note = "{\textcopyright} 2014 by The American Society of Hematology.",
year = "2014",
month = aug,
day = "28",
doi = "10.1182/blood-2014-03-560557",
language = "English",
volume = "124",
pages = "1426--33",
journal = "BLOOD",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "9",

}

RIS

TY - JOUR

T1 - Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy

AU - Döhner, Hartmut

AU - Lübbert, Michael

AU - Fiedler, Walter

AU - Fouillard, Loic

AU - Haaland, Alf

AU - Brandwein, Joseph M

AU - Lepretre, Stephane

AU - Reman, Oumedaly

AU - Turlure, Pascal

AU - Ottmann, Oliver G

AU - Müller-Tidow, Carsten

AU - Krämer, Alwin

AU - Raffoux, Emmanuel

AU - Döhner, Konstanze

AU - Schlenk, Richard F

AU - Voss, Florian

AU - Taube, Tillmann

AU - Fritsch, Holger

AU - Maertens, Johan

N1 - © 2014 by The American Society of Hematology.

PY - 2014/8/28

Y1 - 2014/8/28

N2 - Treatment outcomes for older patients with acute myeloid leukemia (AML) have remained dismal. This randomized, phase 2 trial in AML patients not considered suitable for intensive induction therapy compared low-dose cytarabine (LDAC) with or without volasertib, a highly potent and selective inhibitor of polo-like kinases. Eighty-seven patients (median age 75 years) received LDAC 20 mg twice daily subcutaneously days 1-10 or LDAC + volasertib 350 mg IV days 1 + 15 every 4 weeks. Response rate (complete remission and complete remission with incomplete blood count recovery) was higher for LDAC + volasertib vs LDAC (31.0% vs 13.3%; odds ratio, 2.91; P = .052). Responses in the LDAC + volasertib arm were observed across all genetic groups, including 5 of 14 patients with adverse cytogenetics. Median event-free survival was significantly prolonged by LDAC + volasertib compared with LDAC (5.6 vs 2.3 months; hazard ratio, 0.57; 95% confidence interval, 0.35-0.92; P = .021); median overall survival was 8.0 vs 5.2 months, respectively (hazard ratio, 0.63; 95% confidence interval, 0.40-1.00; P = .047). LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events; there was no increase in the death rate at days 60 + 90. This study was registered at www.clinicaltrials.gov as #NCT00804856.

AB - Treatment outcomes for older patients with acute myeloid leukemia (AML) have remained dismal. This randomized, phase 2 trial in AML patients not considered suitable for intensive induction therapy compared low-dose cytarabine (LDAC) with or without volasertib, a highly potent and selective inhibitor of polo-like kinases. Eighty-seven patients (median age 75 years) received LDAC 20 mg twice daily subcutaneously days 1-10 or LDAC + volasertib 350 mg IV days 1 + 15 every 4 weeks. Response rate (complete remission and complete remission with incomplete blood count recovery) was higher for LDAC + volasertib vs LDAC (31.0% vs 13.3%; odds ratio, 2.91; P = .052). Responses in the LDAC + volasertib arm were observed across all genetic groups, including 5 of 14 patients with adverse cytogenetics. Median event-free survival was significantly prolonged by LDAC + volasertib compared with LDAC (5.6 vs 2.3 months; hazard ratio, 0.57; 95% confidence interval, 0.35-0.92; P = .021); median overall survival was 8.0 vs 5.2 months, respectively (hazard ratio, 0.63; 95% confidence interval, 0.40-1.00; P = .047). LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events; there was no increase in the death rate at days 60 + 90. This study was registered at www.clinicaltrials.gov as #NCT00804856.

U2 - 10.1182/blood-2014-03-560557

DO - 10.1182/blood-2014-03-560557

M3 - SCORING: Journal article

C2 - 25006120

VL - 124

SP - 1426

EP - 1433

JO - BLOOD

JF - BLOOD

SN - 0006-4971

IS - 9

ER -