Posted: Tuesday, July 7, 2020
Based on “exploratory results” from the BRIGHT ANK 1003 post hoc analysis, overall survival approximately doubled when patients with newly diagnosed acute myeloid leukemia (AML) were treated with low-dose cytarabine plus the SMO inhibitor glasdegib versus cytarabine alone. In fact, there appeared to be no “significant worsening of myelosuppression-related complications” with the combination therapy, announced Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, and colleagues. These findings were presented in a poster session during the ASCO20 Virtual Scientific Program (Abstract 7525).
Specifically, the investigators assessed the associations of early blood cell counts with overall survival in the study arms that received glasdegib and low-dose cytarabine alone, whether or not the patients ultimately met thresholds of absolute neutrophil count (ANC; ≥ 1,000 or 500/µL), hemoglobin (≥ 10 or 9 g/dL), or platelets (≥ 100,000 or 50,000/µL).
In the study, 78 newly diagnosed patients were randomly assigned to glasdegib plus low-dose cytarabine, whereas 38 received low-dose cytarabine alone. The peripheral blood cell counts were initially measured approximately 1 month before the first bone marrow assessments. “Among all patients, regardless of baseline values, achievement of ANC, hemoglobin, and platelet thresholds at day 1 of cycle 2 was associated with improved overall survival with glasdegib plus low-dose cytarabine LDAC,” the authors wrote. Of note, even in patients who did not meet these thresholds, there was an overall survival benefit with the combination therapy (all P ≤ .05).
For instance, in the 30 patients who met the 100,000 platelets/µL threshold, median overall survival was 18.5 months. and 4.3 months for the 24 and 6 patients in the glasdegib and low-dose cytarabine–alone arms, respectively. And, for those 45 patients who did not meet the 1,000 ANC/µL threshold, median overall survival was 12.5 months, and 4.8 months for the 33 and 12 patients in the glasdegib and low-dose cytarabine–alone arms, respectively.
Disclosure: The study authors’ disclosure information can be found at coi.asco.org.