Fix low dose venetoclax-azacitidine treatment of unfit acute myeloid leukemia patients

Eur J Haematol. 2024 Aug;113(2):183-189. doi: 10.1111/ejh.14213. Epub 2024 Apr 21.

Abstract

The prognosis of elderly AML patients had not even been improved by using hypomethylating agents; however, synergistic effect of combining azacitidin with venetoclax had resulted in a remarkable therapeutic advance. Our goal was to study the latter treatment with a new dosing regimen in a retrospective/observational study. In our department, we analyzed the data of AML patients who were unfit for curative high-dose treatment and accepted the medication with a fixed-dose of azacitidin and venetoclax combination (AZA-VEN, 100 mg sc for 7 days-100 mg per os continuously). The primary end point was the overall survival. In total, 55 AML patients received the treatment between OCT/2019-DEC/2022. Mean age was 69.4-year (48-84), median overall survival was 17.2-month (95% CI, 14.3-20.10) Composite CR: (CR + CRi) 62%. Side effect CTCAE 3 or higher: neutropenia with fever: 36.4%, anemia: 29.1%, thrombocytopenia: 16.4% and nausea 20%. AZA-VEN combination treatment of our unfit AML patients was found to be a good therapeutic option. The results achieved with significantly lower doses of the fixed dose of AZA-VEN are comparable to the conclusions of the VIALE-A study, and the less severe side effects we have observed are explained by the milder neutropenia of the newly introduced regimen.

Keywords: acute myeloid leukemia; azacitidine; fix dose; venetoclax.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Azacitidine* / administration & dosage
  • Azacitidine* / adverse effects
  • Azacitidine* / therapeutic use
  • Bridged Bicyclo Compounds, Heterocyclic* / administration & dosage
  • Bridged Bicyclo Compounds, Heterocyclic* / adverse effects
  • Bridged Bicyclo Compounds, Heterocyclic* / therapeutic use
  • Female
  • Humans
  • Leukemia, Myeloid, Acute* / diagnosis
  • Leukemia, Myeloid, Acute* / drug therapy
  • Leukemia, Myeloid, Acute* / mortality
  • Male
  • Middle Aged
  • Prognosis
  • Retrospective Studies
  • Sulfonamides* / administration & dosage
  • Sulfonamides* / adverse effects
  • Sulfonamides* / therapeutic use
  • Treatment Outcome

Substances

  • venetoclax
  • Bridged Bicyclo Compounds, Heterocyclic
  • Sulfonamides
  • Azacitidine