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Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial

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Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial. / Heuser, Michael; Smith, B Douglas; Fiedler, Walter; Sekeres, Mikkael A; Montesinos, Pau; Leber, Brian; Merchant, Akil; Papayannidis, Cristina; Pérez-Simón, José A; Hoang, Caroline J; O'Brien, Thomas; Ma, Weidong Wendy; Zeremski, Mirjana; O'Connell, Ashleigh; Chan, Geoffrey; Cortes, Jorge E.

in: ANN HEMATOL, Jahrgang 100, Nr. 5, 05.2021, S. 1181-1194.

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

Harvard

Heuser, M, Smith, BD, Fiedler, W, Sekeres, MA, Montesinos, P, Leber, B, Merchant, A, Papayannidis, C, Pérez-Simón, JA, Hoang, CJ, O'Brien, T, Ma, WW, Zeremski, M, O'Connell, A, Chan, G & Cortes, JE 2021, 'Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial', ANN HEMATOL, Jg. 100, Nr. 5, S. 1181-1194. https://doi.org/10.1007/s00277-021-04465-4

APA

Heuser, M., Smith, B. D., Fiedler, W., Sekeres, M. A., Montesinos, P., Leber, B., Merchant, A., Papayannidis, C., Pérez-Simón, J. A., Hoang, C. J., O'Brien, T., Ma, W. W., Zeremski, M., O'Connell, A., Chan, G., & Cortes, J. E. (2021). Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial. ANN HEMATOL, 100(5), 1181-1194. https://doi.org/10.1007/s00277-021-04465-4

Vancouver

Heuser M, Smith BD, Fiedler W, Sekeres MA, Montesinos P, Leber B et al. Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial. ANN HEMATOL. 2021 Mai;100(5):1181-1194. https://doi.org/10.1007/s00277-021-04465-4

Bibtex

@article{e558ef5fd36e488dbd654c2b5de221df,
title = "Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial",
abstract = "This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395-1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151-0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days' therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.",
keywords = "Aged, Aged, 80 and over, Antineoplastic Agents/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Benzimidazoles/administration & dosage, Cytarabine/administration & dosage, Female, Humans, Leukemia, Myeloid, Acute/drug therapy, Male, Middle Aged, Neoplasms, Second Primary/drug therapy, Phenylurea Compounds/administration & dosage, Survival Analysis, Treatment Outcome",
author = "Michael Heuser and Smith, {B Douglas} and Walter Fiedler and Sekeres, {Mikkael A} and Pau Montesinos and Brian Leber and Akil Merchant and Cristina Papayannidis and P{\'e}rez-Sim{\'o}n, {Jos{\'e} A} and Hoang, {Caroline J} and Thomas O'Brien and Ma, {Weidong Wendy} and Mirjana Zeremski and Ashleigh O'Connell and Geoffrey Chan and Cortes, {Jorge E}",
year = "2021",
month = may,
doi = "10.1007/s00277-021-04465-4",
language = "English",
volume = "100",
pages = "1181--1194",
journal = "ANN HEMATOL",
issn = "0939-5555",
publisher = "Springer",
number = "5",

}

RIS

TY - JOUR

T1 - Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial

AU - Heuser, Michael

AU - Smith, B Douglas

AU - Fiedler, Walter

AU - Sekeres, Mikkael A

AU - Montesinos, Pau

AU - Leber, Brian

AU - Merchant, Akil

AU - Papayannidis, Cristina

AU - Pérez-Simón, José A

AU - Hoang, Caroline J

AU - O'Brien, Thomas

AU - Ma, Weidong Wendy

AU - Zeremski, Mirjana

AU - O'Connell, Ashleigh

AU - Chan, Geoffrey

AU - Cortes, Jorge E

PY - 2021/5

Y1 - 2021/5

N2 - This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395-1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151-0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days' therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.

AB - This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325-0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395-1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151-0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days' therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents/administration & dosage

KW - Antineoplastic Combined Chemotherapy Protocols/administration & dosage

KW - Benzimidazoles/administration & dosage

KW - Cytarabine/administration & dosage

KW - Female

KW - Humans

KW - Leukemia, Myeloid, Acute/drug therapy

KW - Male

KW - Middle Aged

KW - Neoplasms, Second Primary/drug therapy

KW - Phenylurea Compounds/administration & dosage

KW - Survival Analysis

KW - Treatment Outcome

U2 - 10.1007/s00277-021-04465-4

DO - 10.1007/s00277-021-04465-4

M3 - SCORING: Journal article

C2 - 33740113

VL - 100

SP - 1181

EP - 1194

JO - ANN HEMATOL

JF - ANN HEMATOL

SN - 0939-5555

IS - 5

ER -