Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy
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Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy. / Cortes, Jorge E; Heidel, Florian H; Fiedler, Walter; Smith, B Douglas; Robak, Tadeusz; Montesinos, Pau; Candoni, Anna; Leber, Brian; Sekeres, Mikkael A; Pollyea, Daniel A; Ferdinand, Roxanne; Ma, Weidong Wendy; O'Brien, Thomas; O'Connell, Ashleigh; Chan, Geoffrey; Heuser, Michael.
In: J HEMATOL ONCOL, Vol. 13, No. 1, 14.07.2020, p. 92.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy
AU - Cortes, Jorge E
AU - Heidel, Florian H
AU - Fiedler, Walter
AU - Smith, B Douglas
AU - Robak, Tadeusz
AU - Montesinos, Pau
AU - Candoni, Anna
AU - Leber, Brian
AU - Sekeres, Mikkael A
AU - Pollyea, Daniel A
AU - Ferdinand, Roxanne
AU - Ma, Weidong Wendy
AU - O'Brien, Thomas
AU - O'Connell, Ashleigh
AU - Chan, Geoffrey
AU - Heuser, Michael
PY - 2020/7/14
Y1 - 2020/7/14
N2 - 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/μl, 45.6% vs 35.5%), hemoglobin (≥ 9 g/dl, 54.4% vs 38.7%), and platelets (≥ 100,000/μl, 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).
AB - 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/μl, 45.6% vs 35.5%), hemoglobin (≥ 9 g/dl, 54.4% vs 38.7%), and platelets (≥ 100,000/μl, 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).
U2 - 10.1186/s13045-020-00929-8
DO - 10.1186/s13045-020-00929-8
M3 - SCORING: Journal article
C2 - 32664995
VL - 13
SP - 92
JO - J HEMATOL ONCOL
JF - J HEMATOL ONCOL
SN - 1756-8722
IS - 1
ER -