Andrew Wei, MBBS, discusses characteristics associated with long-term survival in the QUAZAR AML-001 trial of oral azacitidine in patients with acute myeloid leukemia.
Andrew Wei, MBBS, PhD, adjunct associate professor at the Australian Centre for Blood Diseases at Monash University, discusses characteristics associated with long-term survival in the QUAZAR AML-001 trial (NCT01757535) of oral azacitidine (Onureg) in patients with acute myeloid leukemia (AML).
The phase 3 QUAZAR AML-001 trial investigated oral azacitidine in patients in their first remission of AML. Patients received azacitidine or placebo as maintenance. At the initial data cutoff in July 2019, azacitidine showed a significant overall survival advantage over placebo. Ata later follow-up of September 2020, investigators collected data about patients in both groups with long-term survival of 3 years or more.
According to Wei, of the 83 patients in the azacitidine arm who lived at least 3 years, they had a median age of 67 versus 69 for those who did not survive at least 3 years. Only 6% had adverse cytogenic risk compared with 19% in those who did not survive up to 3 years. An NPM1 mutation was identified at diagnosis in 45% of those who lived at least 3 years versus only 19% in those who did not.
0:08 | We next looked at the patients who had survival for at least 3 years and asked the question, “What were the characteristics of these patients that had long-term survival in the oral azacitidine arm?” What we noticed were several observations. First of all, long-term survivors were slightly younger. Second, they were less likely to have adverse cytogenetic risk characteristics. And third, patients were more likely to have the NPM1 mutation.
So for example, patients in the oral azacitidine arm who were longer-term survivors beyond 3 years were aged 67, compared to 69 amongst those [who] survived for shorter periods. Second, the proportion of patients with adverse cytogenic risk amongst long-term survivors was only 6% versus 19% amongst those [who] didn't have long-term survival. And third, the proportion of patients with NPM1 mutation in the long-term survivor group was 45%, compared [with] 19% amongst those that survived less than 3 years.