Lower Intensity Therapy With Cladribine/Low Dose Cytarabine/Venetoclax in Older Patients With Acute Myeloid Leukemia Compares Favorably With Intensive Chemotherapy Among Patients Undergoing Allogeneic Stem Cell Transplantation

Authors

Jayastu Senapati
Hagop M Kantarjian
Alexandre Bazinet
Patrick Reville
Nicholas J Short
Naval Daver
Gautam Borthakur
Alex Bataller
Elias Jabbour
Courtney DiNardo
Fadi Haddad
Koji Sasaki
Uday Popat
Betul Oran
Amin M Alousi
Sanam Loghavi
Elizabeth Shpall
Guillermo Garcia-Manero
Farhad Ravandi
Tapan M Kadia

Language

English

Publication Date

10-1-2024

Journal

Cancer

DOI

10.1002/cncr.35388

PMID

38809547

PMCID

PMC12132108

PubMedCentral® Posted Date

10-1-2025

PubMedCentral® Full Text Version

Author MSS

Abstract

Background: Allogeneic stem cell transplantation (SCT) remains the best consolidative modality in most patients with acute myeloid leukemia (AML). Along with factors directly pertaining to SCT, pretransplantation disease control, performance status, and prior treatment-related complications are important factors that affect posttransplantation survival outcomes.

Methods: The authors compared the survival outcomes of patients ≥60 years of age treated on the phase 2 clinical trial of venetoclax (Ven) added to cladribine (CLAD) and low dose cytarabine (LDAC) alternating with azacitidine (CLAD/LDAC/Ven arm) (NCT03586609) who underwent allogeneic SCT in first remission to a retrospective cohort of patients ≥60 years of age who underwent SCT after intensive chemotherapy. Intensive chemotherapy was defined as the use of cytarabine >1 g/m2 and anthracyclines during induction/consolidation.

Results: Thirty-five patients at median age of 68 years in the CLAD/LDAC/Ven arm were compared to 42 patients at a median age of 62 years in the intensive therapy arm. The 2-year relapse-free survival was superior with CLAD/LDAC/Ven versus intensive chemotherapy (88% vs. 65%; p = .03) whereas the 2-year overall survival (OS) was comparable (84% vs. 70%; p = .14). On a competing event analysis, the 2-year cumulative incidence of relapse (CIR) was significantly lower with CLAD/LDAC/Ven versus intensive chemotherapy (2.9% vs. 17.2%, Gray's p = .049) whereas nonrelapse mortality was comparable (16.2% vs. 17.1%; p = .486).

Conclusion: In conclusion, treatment with CLAD/LDAC/Ven was associated with favorable outcomes in older patients who underwent subsequent allogeneic SCT. The OS was comparable to that with intensive chemotherapy followed by allogeneic SCT, but the CIR rate was significantly lower.

Keywords

Humans, Leukemia, Myeloid, Acute, Male, Aged, Female, Cladribine, Middle Aged, Cytarabine, Antineoplastic Combined Chemotherapy Protocols, Transplantation, Homologous, Retrospective Studies, Sulfonamides, Hematopoietic Stem Cell Transplantation, Bridged Bicyclo Compounds, Heterocyclic, AML, Older patients, stem cell transplantation, Cladribine, Venetoclax

Published Open-Access

yes

Recommended Citation

Senapati, Jayastu; Kantarjian, Hagop M; Bazinet, Alexandre; et al., "Lower Intensity Therapy With Cladribine/Low Dose Cytarabine/Venetoclax in Older Patients With Acute Myeloid Leukemia Compares Favorably With Intensive Chemotherapy Among Patients Undergoing Allogeneic Stem Cell Transplantation" (2024). Faculty, Staff and Student Publications. 5569.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/5569