Posted: Wednesday, January 6, 2021
According to research published in Blood Advances, the use of azacitidine maintenance may merit further study to reduce the risk of relapse in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The phase III, open-label, randomized trial studied the efficacy and safety of azacitidine maintenance in a posttransplant setting, reportedly making it the first study of its kind. Richard E. Champlin, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues showed that a prospective trial in the posttransplant setting was feasible and safe but challenging.
Between 2009 and 2017, 187 patients in complete remission were recruited and randomly assigned to the control arm (n = 94) or the treatment arm (n = 95). Patients in the control arm received no intervention. Patients in the treatment arm were given 32 mg/m2/day of azacitidine subcutaneously for 5 days every 28 days for 12 cycles.
The median number of cycles received was four, and more than 50 patients were excluded due to relapse (n = 29) or study withdrawal (n = 23). With the given dose and schedule, azacitidine maintenance did not improve relapse-free survival in high-risk patients with AML or MDS who underwent hematopoietic stem cell transplantation compared with controls. There were also no significant improvements in secondary endpoints, including overall survival, risk of relapse, or incidence of graft-versus-host disease. However, previous phase II studies showed improvement in outcomes for some high-risk patients with AML or MDS.
“The dose and schedule of azacitidine must be considered when interpreting these results and the potential role of posttransplant maintenance therapies for AML/MDS…. It is possible that a higher dose or different schedule might provide improved results,” the authors proposed.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.