Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy.

ABSTRACT: BACKGROUND:The phase 2 BRIGHT AML 1003 trial evaluated 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 patients to receive glasdegib + LDAC (n = 78) or LDAC alone (n = 38). The rate of complete remission (CR) was 19.2% in the glasdegib + LDAC arm versus 2.6% in the LDAC arm (P = 0.015). METHODS:This post hoc analysis determines whether the clinical benefits of glasdegib are restricted to patients who achieve CR, or if they extend to those who do not achieve CR. RESULTS:In patients who did not achieve CR, the addition of glasdegib to LDAC improved overall survival (OS) versus LDAC alone (hazard ratio = 0.63 [95% confidence interval, 0.41-0.98]; P = 0.0182; median OS, 5.0 vs 4.1?months). Additionally, more patients receiving glasdegib + LDAC achieved durable recovery of absolute neutrophil count (? 1000/?l, 45.6% vs 35.5%), hemoglobin (? 9?g/dl, 54.4% vs 38.7%), and platelets (? 100,000/?l, 29.8% vs 9.7%). Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively. CONCLUSIONS:Collectively, these data suggest that there are clinical benefits with glasdegib in the absence of CR. TRIAL REGISTRATION:ClinicalTrials.gov NCT01546038 (March 7, 2012).

SUBMITTER: Cortes JE 

PROVIDER: S-EPMC7362563 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature