Hartmut Dohner reported the results of the AZA-AML-001 study. Patients 65 years of age or older with newly diagnosed intermediate-risk and high-risk nuclear acute myeloid leukemia (AML) with Eastern Cooperative Oncology Group (ECOG) physical status score 0 to 2 and white blood cell count (WBC) ≤15 × 109/L were selected for the study. before randomization grouping, each patient was pre-selected for one of the following 3 conventional treatments DD ara-Cytosine for 7 days + erythromycin for 3 days (7+3 regimen) chemotherapy, low-dose cytarabine (Ara-C), and supportive therapy only, then patients were randomized to either the azacitidine (AZA) or conventional regimen (CCR) groups. 488 patients participated in the randomization group, 241 in the AZA group and 247 in the CCR; 315 in the intermediate risk group (155 in the AZA group and 160 in the CCR group), of whom 218 had normal karyotype (AZA group 113 cases, 105 cases in the CCR group); 170 cases in the high-risk group (85 cases in the AZA group, 85 cases in the CCR group). In all subgroups (normal karyotype, intermediate risk and high risk groups), the 1-year overall survival (OS) rate was higher in the AZA group than in the CCR group. The same results were obtained in elderly AML patients with pathological hematopoiesis. The investigators suggest that AZA could be used as a starting treatment option for elderly AML.
Comment: The new drugs led to improved efficacy and tolerability of the treatment. The use of demethylating drugs provides options for initial treatment of elderly AML. Could AZA be a first-line treatment option for elderly patients? For elderly AML patients, it is recommended that in addition to assessing the disease itself, a tolerability assessment should be performed prior to treatment, and patients should be classified into 3 levels, appropriate for strong chemotherapy, inappropriate for strong chemotherapy, and supportive therapy only, based on the criteria of comprehensive assessment. In this study, conventional treatment regimens were pre-selected for patients based on tolerability before randomization, with the control group receiving CCR and the study group receiving AZA, and the results supported that AZA could be a first-line option for intermediate-risk and high-risk elderly AML patients. The combination of sorafenib, an inhibitor against FMS-like tyrosine kinase 3 (FLT3), and AZA also achieved satisfactory efficacy in elderly AML patients with FLT3-internal tandem duplication (ITD)-positive AML. In fact, only 1/3 of patients over 60-65 years of age received chemotherapy. Domestic treatment for elderly leukemia is inadequate, and research on elderly AML in has not yet taken shape and should be taken seriously.