RT Journal Article
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.
A1 Heuser, Michael
A1 Smith, B Douglas
A1 Fiedler, Walter
A1 Sekeres, Mikkael A
A1 Montesinos, Pau
A1 Leber, Brian
A1 Merchant, Akil
A1 Papayannidis, Cristina
A1 Perez-Simon, Jose A
A1 Hoang, Caroline J
A1 O'Brien, Thomas
A1 Ma, Weidong Wendy
A1 Zeremski, Mirjana
A1 O'Connell, Ashleigh
A1 Chan, Geoffrey
A1 Cortes, Jorge E
K1 Acute myeloid leukemia
K1 Clinical trial
K1 Glasdegib
K1 Secondary acute myeloid leukemia
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
PB Springer
YR 2021
FD 2021-03-19
LK http://hdl.handle.net/10668/17369
UL http://hdl.handle.net/10668/17369
LA en
NO 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 May;100(5):1181-1194. doi: 10.1007/s00277-021-04465-4. Epub 2021 Mar 19. Erratum in: Ann Hematol. 2021 Jul;100(7):1917-1918.
DS RISalud
RD Apr 7, 2025