Glasdegib plus intensive or non-intensive chemotherapy for
untreated acute myeloid leukemia: results from the randomized,
phase 3 BRIGHT AML 1019 trial

J 2023

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR et. al.

Základní údaje

Originální název

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial

Autoři

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER (203 Česká republika, domácí), Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN a Jorge E CORTES

Vydání

Leukemia, London, Nature Publishing Group, 2023, 0887-6924

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 11.400 v roce 2022

Kód RIV

RIV/00216224:14110/23:00132494

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1038/s41375-023-02001-z

UT WoS

001052018400001

Klíčová slova anglicky

polycythemia vera; ropeginterferon alfa-2b

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 12. 12. 2023 11:33, Mgr. Tereza Miškechová

Anotace

V originále

This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.

Citovat

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER, Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN a Jorge E CORTES. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. London: Nature Publishing Group, 2023, roč. 37, č. 10, s. 2017-2026. ISSN 0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-023-02001-z.

@article{2348884,
   author = {Sekeres, Mikkael A and Montesinos, Pau and Novak, Jan and Wang, Jianxiang and Jeyakumar, Deepa and Tomlinson, Benjamin and Mayer, Jiří and Jou, Erin and Robak, Tadeusz and Taussig, David C and Dombret, Herve and Merchant, Akil and Shaik, Naveed and Brien, Thomas and Roh, Whijae and Liu, Xueli and Ma, Wendy and DiRienzo, Christine G and Chan, Geoffrey and Cortes, Jorge E},
   article_location = {London},
   article_number = {10},
   doi = {http://dx.doi.org/10.1038/s41375-023-02001-z},
   keywords = {polycythemia vera; ropeginterferon alfa-2b},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial},
   url = {https://www.nature.com/articles/s41375-023-02008-6},
   volume = {37},
   year = {2023}
}

TY  - JOUR
ID  - 2348884
AU  - Sekeres, Mikkael A - Montesinos, Pau - Novak, Jan - Wang, Jianxiang - Jeyakumar, Deepa - Tomlinson, Benjamin - Mayer, Jiří - Jou, Erin - Robak, Tadeusz - Taussig, David C - Dombret, Herve - Merchant, Akil - Shaik, Naveed - Brien, Thomas - Roh, Whijae - Liu, Xueli - Ma, Wendy - DiRienzo, Christine G - Chan, Geoffrey - Cortes, Jorge E
PY  - 2023
TI  - Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial
JF  - Leukemia
VL  - 37
IS  - 10
SP  - 2017-2026
EP  - 2017-2026
PB  - Nature Publishing Group
SN  - 08876924
KW  - polycythemia vera
KW  - ropeginterferon alfa-2b
UR  - https://www.nature.com/articles/s41375-023-02008-6
N2  - This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.
ER  -

SEKERES, Mikkael A, Pau MONTESINOS, Jan NOVAK, Jianxiang WANG, Deepa JEYAKUMAR, Benjamin TOMLINSON, Jiří MAYER, Erin JOU, Tadeusz ROBAK, David C TAUSSIG, Herve DOMBRET, Akil MERCHANT, Naveed SHAIK, Thomas BRIEN, Whijae ROH, Xueli LIU, Wendy MA, Christine G DIRIENZO, Geoffrey CHAN a Jorge E CORTES. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. \textit{Leukemia}. London: Nature Publishing Group, 2023, roč.~37, č.~10, s.~2017-2026. ISSN~0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-023-02001-z.

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