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EHA2021: Post Hoc Analysis of Oral Azacitidine in AML From QUAZAR AML-001 Trial

By: Julia Fiederlein
Posted: Monday, June 14, 2021

According to Hartmut Döhner, MD, of Universitätsklinikum Ulm, Germany, and colleagues, maintenance treatment with oral azacitidine seemed to improve overall and relapse-free survival outcomes in patients with de novo acute myeloid leukemia (AML) and intermediate-risk cytogenetics. Furthermore, the post hoc subgroup analysis of the phase III QUAZAR AML-001 trial, presented during the European Hematology Association Virtual Congress (EHA2021; Abstract S131), also suggested that NPM1-mutated disease may be both prognostically favorable and independently predictive of prolonged overall survival with oral azacitidine.

A total of 472 patients with intermediate- or poor-risk AML were randomly assigned in a 1:1 ratio to receive oral azacitidine or a placebo within 4 months of achieving first complete remission with or without incomplete blood cell count recovery. In those with de novo AML, oral azacitidine seemed to significantly prolong the median duration of overall (P = .0068) and relapse-free (P = .0002) survival. There was a trend toward prolonged overall survival (P = .11) and significantly prolonged relapse-free survival (P = .0118) with oral azacitidine in the underpowered subgroup with secondary AML. Patients with intermediate-risk cytogenetics seemed to experience a significantly prolonged duration of overall (P = .0093) and relapse-free (P = .0004) survival with oral azacitidine. In the underpowered poor-risk subgroup, a trend toward prolonged overall (P = .06) and relapse-free (P = .08) survival with oral azacitidine was reported.

In patients treated with the placebo, NPM1-mutated disease seemed to be prognostically favorable for relapse-free survival (P = .0083); a trend toward prolonged overall survival was reported (P = .10). The median durations of overall (P = .0138) and relapse-free (P = .0098) survival in patients with NPM1-mutated disease were longer with oral azacitidine compared with the placebo. Oral azacitidine was found to significantly prolong overall (P = .0365) and relapse-free (P = .0029) survival in patients with wild-type disease.

Disclosure: For full disclosure information for study authors, visit library.ehaweb.org.


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