%0 Journal Article
%A Heuser, Michael
%A Smith, B Douglas
%A Fiedler, Walter
%A Sekeres, Mikkael A
%A Montesinos, Pau
%A Leber, Brian
%A Merchant, Akil
%A Papayannidis, Cristina
%A Perez-Simon, Jose A
%A Hoang, Caroline J
%A O'Brien, Thomas
%A Ma, Weidong Wendy
%A Zeremski, Mirjana
%A O'Connell, Ashleigh
%A Chan, Geoffrey
%A Cortes, Jorge E
%T 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.
%D 2021
%U http://hdl.handle.net/10668/17369
%X 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
%K Acute myeloid leukemia
%K Clinical trial
%K Glasdegib
%K Secondary acute myeloid leukemia
%~