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Clinical Trial
. 2024 Oct 1;130(19):3333-3343.
doi: 10.1002/cncr.35388. Epub 2024 May 29.

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

Jayastu Senapati  1 , Hagop M Kantarjian  1 , Alexandre Bazinet  1 , Patrick Reville  1 , Nicholas J Short  1 , Naval Daver  1 , Gautam Borthakur  1 , Alex Bataller  1 , Elias Jabbour  1 , Courtney DiNardo  1 , Fadi Haddad  1 , Koji Sasaki  1 , Uday Popat  2 , Betul Oran  2 , Amin M Alousi  2 , Sanam Loghavi  3 , Elizabeth Shpall  2 , Guillermo Garcia-Manero  1 , Farhad Ravandi  1 , Tapan M Kadia  1
Affiliations
Clinical Trial

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

Jayastu Senapati et al. Cancer. .

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: AML; cladribine; older patients; stem cell transplantation; venetoclax.

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References

    1. National Cancer Institute. SEER Cancer Stat Facts- Acute Myeloid Leukemia (AML) 2023. [updated January 12, 2023. Available from: https://seer.cancer.gov/statfacts/html/amyl.html.
    1. Kantarjian H, Kadia T, DiNardo C, Daver N, Borthakur G, Jabbour E, et al. Acute myeloid leukemia: current progress and future directions. Blood Cancer Journal. 2021;11(2):41. - PMC - PubMed
    1. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. The Lancet. - PubMed
    1. Klepin HD, Estey E, Kadia T. More Versus Less Therapy for Older Adults With Acute Myeloid Leukemia: New Perspectives on an Old Debate. American Society of Clinical Oncology Educational Book. 2019(39):421–32. - PubMed
    1. Short NJ, Kantarjian H. Choosing between intensive and less intensive front-line treatment approaches for older patients with newly diagnosed acute myeloid leukaemia. The Lancet Haematology. 2022;9(7):e535–e45. - PubMed

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