Andrew Wei, MBBS, PhD, discusses outcomes related to 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 outcomes related to long-term survival in the QUAZAR AML-001 trial (NCT01757535) of oral azacitidine (Onureg) in patients with acute myeloid leukemia (AML).
Investigators in the phase 3 QUAZAR AML-001 study investigated azacitidine versus placebo as maintenance therapy for patients in their first remission of AML. In updated results at a median follow-up of 51.7 months, those receiving azacitidine had a median overall survival of 24.7 months versus 14.8 months with placebo, and 23% were long-term survivors versus 15% with placebo.
Participants were eligible following induction therapy with or without consolidation therapy, and according to Wei, those who had received prior consolidation therapy were not more likely to survive long term.
Wei says that 35% of patients in the long-term survivor group began the trial while positive for minimal residual disease (MRD), while a greater proportion of patients who did not survive in the long term were MRD-positive. Among patients who received oral azacitidine, 76% became MRD-negative in the long-term survival group versus only 22% of those who did not survive for at least 3 years.
0:08 | We asked the question of whether patients in the long-term survival group with azacitidine had more prior consolidation therapy or not. And the answer was no, prior consolidation therapy didn't appear to make a substantial difference to whether a patient might be considered a long-term survivor or not. In fact, 23% of patients in that oral azacitidine that didn't receive any consolidation therapy were in this long-term survival group.
The last question we addressed was the role of MRD. And we did note that the proportion of patients who were MRD-positive at the time of initiation of therapy with long-term survival was much less common then in the group that didn't have long-term survival. So 35% of patients entered with MRD positivity in the long-term survivor group. Furthermore, in the oral azacitidine arm, a greater proportion of patients converted to MRD negativity in the long-term survival group. So 76% of patients became MRD-negative in the long term survival group compared to only 22% in the non–long-term survival group.