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Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome

Standard

Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. / Cortes, Jorge E; Heidel, Florian H; Hellmann, Andrzej; Fiedler, Walter; Smith, B Douglas; Robak, Tadeusz; Montesinos, Pau; Pollyea, Daniel A; DesJardins, Pierre; Ottmann, Oliver; Ma, Weidong Wendy; Shaik, M Naveed; Laird, A Douglas; Zeremski, Mirjana; O'Connell, Ashleigh; Chan, Geoffrey; Heuser, Michael.

in: LEUKEMIA, Jahrgang 33, Nr. 2, 02.2019, S. 379-389.

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

Harvard

Cortes, JE, Heidel, FH, Hellmann, A, Fiedler, W, Smith, BD, Robak, T, Montesinos, P, Pollyea, DA, DesJardins, P, Ottmann, O, Ma, WW, Shaik, MN, Laird, AD, Zeremski, M, O'Connell, A, Chan, G & Heuser, M 2019, 'Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome', LEUKEMIA, Jg. 33, Nr. 2, S. 379-389. https://doi.org/10.1038/s41375-018-0312-9

APA

Cortes, J. E., Heidel, F. H., Hellmann, A., Fiedler, W., Smith, B. D., Robak, T., Montesinos, P., Pollyea, D. A., DesJardins, P., Ottmann, O., Ma, W. W., Shaik, M. N., Laird, A. D., Zeremski, M., O'Connell, A., Chan, G., & Heuser, M. (2019). Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. LEUKEMIA, 33(2), 379-389. https://doi.org/10.1038/s41375-018-0312-9

Vancouver

Cortes JE, Heidel FH, Hellmann A, Fiedler W, Smith BD, Robak T et al. Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. LEUKEMIA. 2019 Feb;33(2):379-389. https://doi.org/10.1038/s41375-018-0312-9

Bibtex

@article{562cb1987eee4134ab7d889b962eb092,
title = "Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome",
abstract = "Glasdegib is a Hedgehog pathway inhibitor. This phase II, randomized, open-label, multicenter study (ClinicalTrials.gov, NCT01546038) evaluated the efficacy of glasdegib plus low-dose cytarabine (LDAC) in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome unsuitable for intensive chemotherapy. Glasdegib 100 mg (oral, QD) was administered continuously in 28-day cycles; LDAC 20 mg (subcutaneous, BID) was administered for 10 per 28 days. Patients (stratified by cytogenetic risk) were randomized (2:1) to receive glasdegib/LDAC or LDAC. The primary endpoint was overall survival. Eighty-eight and 44 patients were randomized to glasdegib/LDAC and LDAC, respectively. Median (80% confidence interval [CI]) overall survival was 8.8 (6.9-9.9) months with glasdegib/LDAC and 4.9 (3.5-6.0) months with LDAC (hazard ratio, 0.51; 80% CI, 0.39-0.67, P = 0.0004). Fifteen (17.0%) and 1 (2.3%) patients in the glasdegib/LDAC and LDAC arms, respectively, achieved complete remission (P < 0.05). Nonhematologic grade 3/4 all-causality adverse events included pneumonia (16.7%) and fatigue (14.3%) with glasdegib/LDAC and pneumonia (14.6%) with LDAC. Clinical efficacy was evident across patients with diverse mutational profiles. Glasdegib plus LDAC has a favorable benefit-risk profile and may be a promising option for AML patients unsuitable for intensive chemotherapy.",
keywords = "Journal Article",
author = "Cortes, {Jorge E} and Heidel, {Florian H} and Andrzej Hellmann and Walter Fiedler and Smith, {B Douglas} and Tadeusz Robak and Pau Montesinos and Pollyea, {Daniel A} and Pierre DesJardins and Oliver Ottmann and Ma, {Weidong Wendy} and Shaik, {M Naveed} and Laird, {A Douglas} and Mirjana Zeremski and Ashleigh O'Connell and Geoffrey Chan and Michael Heuser",
year = "2019",
month = feb,
doi = "10.1038/s41375-018-0312-9",
language = "English",
volume = "33",
pages = "379--389",
journal = "LEUKEMIA",
issn = "0887-6924",
publisher = "NATURE PUBLISHING GROUP",
number = "2",

}

RIS

TY - JOUR

T1 - Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome

AU - Cortes, Jorge E

AU - Heidel, Florian H

AU - Hellmann, Andrzej

AU - Fiedler, Walter

AU - Smith, B Douglas

AU - Robak, Tadeusz

AU - Montesinos, Pau

AU - Pollyea, Daniel A

AU - DesJardins, Pierre

AU - Ottmann, Oliver

AU - Ma, Weidong Wendy

AU - Shaik, M Naveed

AU - Laird, A Douglas

AU - Zeremski, Mirjana

AU - O'Connell, Ashleigh

AU - Chan, Geoffrey

AU - Heuser, Michael

PY - 2019/2

Y1 - 2019/2

N2 - Glasdegib is a Hedgehog pathway inhibitor. This phase II, randomized, open-label, multicenter study (ClinicalTrials.gov, NCT01546038) evaluated the efficacy of glasdegib plus low-dose cytarabine (LDAC) in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome unsuitable for intensive chemotherapy. Glasdegib 100 mg (oral, QD) was administered continuously in 28-day cycles; LDAC 20 mg (subcutaneous, BID) was administered for 10 per 28 days. Patients (stratified by cytogenetic risk) were randomized (2:1) to receive glasdegib/LDAC or LDAC. The primary endpoint was overall survival. Eighty-eight and 44 patients were randomized to glasdegib/LDAC and LDAC, respectively. Median (80% confidence interval [CI]) overall survival was 8.8 (6.9-9.9) months with glasdegib/LDAC and 4.9 (3.5-6.0) months with LDAC (hazard ratio, 0.51; 80% CI, 0.39-0.67, P = 0.0004). Fifteen (17.0%) and 1 (2.3%) patients in the glasdegib/LDAC and LDAC arms, respectively, achieved complete remission (P < 0.05). Nonhematologic grade 3/4 all-causality adverse events included pneumonia (16.7%) and fatigue (14.3%) with glasdegib/LDAC and pneumonia (14.6%) with LDAC. Clinical efficacy was evident across patients with diverse mutational profiles. Glasdegib plus LDAC has a favorable benefit-risk profile and may be a promising option for AML patients unsuitable for intensive chemotherapy.

AB - Glasdegib is a Hedgehog pathway inhibitor. This phase II, randomized, open-label, multicenter study (ClinicalTrials.gov, NCT01546038) evaluated the efficacy of glasdegib plus low-dose cytarabine (LDAC) in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome unsuitable for intensive chemotherapy. Glasdegib 100 mg (oral, QD) was administered continuously in 28-day cycles; LDAC 20 mg (subcutaneous, BID) was administered for 10 per 28 days. Patients (stratified by cytogenetic risk) were randomized (2:1) to receive glasdegib/LDAC or LDAC. The primary endpoint was overall survival. Eighty-eight and 44 patients were randomized to glasdegib/LDAC and LDAC, respectively. Median (80% confidence interval [CI]) overall survival was 8.8 (6.9-9.9) months with glasdegib/LDAC and 4.9 (3.5-6.0) months with LDAC (hazard ratio, 0.51; 80% CI, 0.39-0.67, P = 0.0004). Fifteen (17.0%) and 1 (2.3%) patients in the glasdegib/LDAC and LDAC arms, respectively, achieved complete remission (P < 0.05). Nonhematologic grade 3/4 all-causality adverse events included pneumonia (16.7%) and fatigue (14.3%) with glasdegib/LDAC and pneumonia (14.6%) with LDAC. Clinical efficacy was evident across patients with diverse mutational profiles. Glasdegib plus LDAC has a favorable benefit-risk profile and may be a promising option for AML patients unsuitable for intensive chemotherapy.

KW - Journal Article

U2 - 10.1038/s41375-018-0312-9

DO - 10.1038/s41375-018-0312-9

M3 - SCORING: Journal article

C2 - 30555165

VL - 33

SP - 379

EP - 389

JO - LEUKEMIA

JF - LEUKEMIA

SN - 0887-6924

IS - 2

ER -