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. 2024 Apr;112(4):530-537.
doi: 10.1111/ejh.14140. Epub 2023 Nov 29.

Azacitidine-venetoclax versus azacitidine salvage treatment for primary induction failure or first relapsed acute myeloid leukaemia patients

C Petit  1 , C Saillard  1 , B Mohty  1 , Y Hicheri  1 , F Villetard  1 , V Maisano  1 , A Charbonnier  1 , J Rey  1 , E D'Incan  1 , C Rouzaud  1 , V Gelsi-Boyer  2 , A Murati  3 , A C Lhoumeau  3 , A Ittel  3 , M J Mozziconacci  3 , A S Alary  3 , M-A Hospital  1 , N Vey  4 , S Garciaz  4
Affiliations

Azacitidine-venetoclax versus azacitidine salvage treatment for primary induction failure or first relapsed acute myeloid leukaemia patients

C Petit et al. Eur J Haematol. 2024 Apr.

Abstract

Objectives: To compare the efficacy of venetoclax-azacitidine (VEN-AZA) with AZA in the real-life for patients with first relapsed or refractory acute myeloid leukaemia (R/R AML).

Methods: We retrospectively analysed R/R AML patients treated with VEN-AZA at the Institut Paoli Calmettes between September 2020 and February 2022. We compared them to a historical cohort of patients treated with AZA between 2010 and 2021.

Results: Thirty-five patients treated with VEN-AZA were compared with 140 patients treated with AZA. There were more favourable cytogenetics (25.7% vs. 8.6%; p = 0.01) and less FLT3-ITD mutated AML (8.8% vs. 25.5%; p = .049) in the VEN-AZA group. The overall 30-day mortality rate was 7.4% and the overall 90-day mortality was 20%, with no difference between the groups. The complete remission rate was 48.6% in the VEN-AZA group versus 15% (p < .0001). The composite complete response rate was 65.7% in the VEN-AZA group versus 23.6% (p < .0001). OS was 12.8 months in the VEN-AZA group versus 7.3 months (p = 0.059). Patients with primary refractory AML, poor-risk cytogenetics, prior hematopoietic stem-cell transplantation (HSCT) and FLT3-ITD mutated AML had lower response and survival rates.

Conclusion: VEN-AZA was associated with a better response rate and a longer survival than AZA monotherapy in AML patients who relapsed after or were refractory to intensive chemotherapy.

Keywords: acute myeloide leukemia; azacitidine; refractory; relapse; venetoclax.

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