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Association details:
Biomarker:CSF3R mutation
Cancer:Acute Myelogenous Leukemia
Drug:azacitidine (DNA methylation inhibitor)
Regimen:HIA (cytarabine + idarubicin hydrochloride + Synribo (omacetaxine mepesuccinate))
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1420 Azacitidine Combined with Homoharringtonine, Idarubicin/Daunorubicin, Cytarabine for Previously Untreated Patients with Acute Myeloid Leukemia: A Single-Center, Phase 2 Study

Published date:
11/03/2022
Excerpt:
The CR/CRi was achieved in 95.0% (19/20) (Fig. 1B). 94.7% (18/19) reached CR/CRi after the 1st cycle of induction therapy and the median time was 25.0d (IQR, 21.0 to 27.0)...The estimated 2-year OS and RFS were 87.4% (95%CI, 58.1% to 96.7%) (Fig. 1C) and 82.0% (95%CI, 53.1% to 94.0%), respectively (Fig. 1D). No survival difference was observed between the favorable and intermediate versus poor-risk groups in both OS and RFS (Fig. 1E& 1F). Meanwhile, the estimated 2-year OS and RFS possibility of the favorable and intermediate-risk group was 90.9% (95%CI, 50.8% to 98.7%) and 80.0% (95%CI, 20.4% to 96.9%), respectively (Fig. 1E& 1F).We detected 30 mutants in 17 of 58 leukemia driver genes at the timepoint of enrollment. The median mutation number/patient was 1.50 (range, 0-4), and 17 of 20 (85.0%) patients had more than one mutation (≥1) (Fig. 1G). The most frequently mutated genes were FLT3 (ITD/TKD) (20.0%), KIT (15.0%), NRAS (15.0%), and DNMT3A (15.0%) (Fig. 1G). More than half of the patients (11/20) harbored the mutated genes involved in signal transducers (FLT3, KRAS, NRAS, KIT, PTPN11, CSF3R; 11/20, 55.0%), and all these patients achieved CR/CRi (11/11, 100%) after induction therapy (Fig 1G).This trial demonstrated that the adding of Aza to HIA/HDA regimen is an effective first-line therapy for previously untreated young or fit AML patients, with high efficacy and well tolerance.
Secondary therapy:
cytarabine + daunorubicin
DOI:
https://doi.org/10.1182/blood-2022-164898
Trial ID: