Abstract
The administration of azacitidine (AZA) was found to be more effective than conventional care regimen (CCR) in patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) with lower blast count. We designed a study to determine efficacy and safety of AZA therapy in “real life” patients with MDS, CMML and AML. The study included 83 patients (65% male) with a median age at diagnosis of 68 years. 43 patients were diagnosed with higher-risk MDS, 30 had AML and 10-CMML. Median AZA dose was comparable between treated groups. AZA dose reduction was required for 44% of MDS, 17% of AML and 25% of CMML patients. Complete remission (CR) was achieved in 14% of MDS, 7% of AML and 10% of CMML patients. Overall response rate was following: 27% for MDS, 20% for AML and 20% for CMML. Estimated OS at 12 months was 75% for MDS, 60% for AML and 75% for CMML. Median follow-up for MDS/AML/CMML from AZA initiation to last follow-up was 9.0, 9.4 and 9.4 months, respectively. The most common toxicity of AZA therapy was myelosuppression and infections. AZA treatment was effective in a limited number of patients with acceptable safety profile.
Highlights
The unique mechanism of action of azacitidine (AZA) is associated with inhibition of DNA methyltransferase, enzyme which is thought to be responsible for DNA methylation
Cytogenetics testing was performed on all study patients prior to AZA initiation, the results were obtained in 65% of subjects
The median number of AZA cycles was 6 for myelodysplastic syndrome (MDS) cohort whereas acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) patients received a median of 4 AZA cycles
Summary
The unique mechanism of action of azacitidine (AZA) is associated with inhibition of DNA methyltransferase, enzyme which is thought to be responsible for DNA methylation. Gene expression is altered which leads to reactivation of epigenetically silenced suppressor genes [1]. AZA is a hypomethylating agent known to be effective for the treatment of higher-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) with lower blast count. The treatment protocol including AZA at a dose of 75 mg/m2 per day for 7 days. AZA therapy was generally well-tolerated and the most common grade 3/4 adverse event was myelosuppression. Slower recovery of blood parameters was responsible for treatment delay or dose reduction. Toxicity of AZA was usually transient and decreased over time [6]
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