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We have extensively covered results from the phase III QUAZAR AML-001 trial, highlighting improved overall survival and relapse-free survival with oral azacitidine maintenance versus placebo in elderly patients in first complete remission. Less detailed is the impact of oral azacitidine maintenance on health-related quality of life in these patients. In addition to gastrointestinal (GI) symptoms, myelosuppressive effects were commonly reported in this trial.1 It is important to analyze the management of adverse events (AEs), and fully detail their onset.
In our latest trial update, we summarize a safety analysis of QUAZAR AML-001 that investigated commonly observed GI and hematologic events, as well as practical recommendations to manage such symptoms. This analysis was recently published by Ravandi et al.1 in the Journal of Hematology & Oncology.
For a summary of the trial design, including eligibility criteria, click here.
Safety was assessed in all patients who received ≥1 dose of the study drug.
We recently reported GI AEs, which were mostly low grade, in our editorial theme. We also summarized early intervention of GI symptoms with concomitant medication or azacitidine dose modifications.
Figure 1. Azacitidine dose modifications*
*Data from Ravandi, et al.1
Figure 2. Dose modification of azacitidine according to hematologic AEs*
AE, adverse event; ANC, absolute neutrophil count.
*Adapted from Ravandi, et al.1
Overall, this study demonstrated a manageable safety profile for oral azacitidine maintenance, with a low number of patients discontinuing treatment. Similar to GI effects, hematologic AEs were controlled mostly through dose reductions and treatment interruptions, in adherence with expert guidelines. Implementation of these interventions will help improve treatment adherence and survival outcomes. Regarding the overlap of cytopenia in cases of relapse and azacitidine treatment, investigators noted that persistent neutropenia and cytopenia following dose modification and schedule changes may signal oncoming relapse.
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