Selective efficacy of venetoclax in unfit patients with acute myeloid leukemia with myelodysplasia-related gene mutations under low-intensity therapy

Ann Hematol. 2025 May;104(5):2717-2729. doi: 10.1007/s00277-025-06399-7. Epub 2025 May 22.

Abstract

According to the 2022 International Consensus Classification (ICC) guidelines, nine myelodysplasia-related (MDS-related) gene mutations are classified as adverse-risk markers in acute myeloid leukemia (AML) under intensive therapy (INT). Although venetoclax (VEN) has demonstrated clinical benefit in subsets of AML with MDS-related gene mutations (AML-MR), its efficacy across all nine mutations remains unclear. In this retrospective study involving 453 AML-MR patients, the overall composite complete remission (CRc) rate was 62.6% (275/439). Among fit patients receiving INT, 57.7% (86/149) achieved CRc after a single cycle of induction therapy (IND1), while 62.7% (79/126) of unfit patients receiving low-intensity therapy (LIT) achieved CRc after IND1. VEN significantly improved CRc rates in unfit patients treated with LIT (45.9% vs. 30.0%, P = 0.002), but not in fit patients receiving INT (61.1% vs. 45.0%, P = 0.052). In both groups, CRc after IND1 was strongly associated with improved overall survival (OS). Subgroup analysis showed that hematopoietic stem cell transplantation (HSCT) significantly prolonged OS and relapse-free survival (RFS) in patients without favorable-risk cytogenetics (P = 0.002 for OS, P < 0.001 for RFS), but conferred no survival benefit in those with favorable-risk cytogenetics (P = 0.119 for OS, P = 0.437 for RFS). These findings support the use of VEN to enhance early remission and survival outcomes in unfit AML-MR patients and suggest that HSCT should be considered primarily in those lacking favorable-risk cytogenetics.

Keywords: Acute myeloid leukemia; Hematopoietic stem cell transplantation; Intensive therapy; Low-intensity therapy; Myelodysplasia-related gene mutation; Venetoclax.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents* / administration & dosage
  • Antineoplastic Agents* / therapeutic use
  • Bridged Bicyclo Compounds, Heterocyclic* / administration & dosage
  • Bridged Bicyclo Compounds, Heterocyclic* / therapeutic use
  • Female
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Leukemia, Myeloid, Acute* / drug therapy
  • Leukemia, Myeloid, Acute* / genetics
  • Leukemia, Myeloid, Acute* / mortality
  • Male
  • Middle Aged
  • Mutation*
  • Myelodysplastic Syndromes* / drug therapy
  • Myelodysplastic Syndromes* / genetics
  • Myelodysplastic Syndromes* / mortality
  • Remission Induction
  • Retrospective Studies
  • Sulfonamides* / administration & dosage
  • Sulfonamides* / therapeutic use
  • Treatment Outcome

Substances

  • venetoclax
  • Sulfonamides
  • Bridged Bicyclo Compounds, Heterocyclic
  • Antineoplastic Agents