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Allo-HSCT vs consolidation therapy to improve leukemia-free survival in elderly patients with AML

May 23, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in the treatment of acute myeloid leukemia.

A significant proportion of older patients with acute myeloid leukemia (AML) will relapse after conventional treatment. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) has been shown to reduce the risk of relapse and is being increasingly used in older patients. To date, randomized studies investigating allo-HSCT in elderly patients remain limited.

During the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation, Niederwieser presented results from a randomized phase III study (NCT00766779) investigating whether allo-HSCT improves leukemia-free survival (LFS) vs non-allo-HSCT consolidation therapy in elderly patients with AML. We summarize this presentation below. 

Study design1 

  • Patients aged 60 and 75 years with AML were randomized 2:1 to receive fludarabine/total body irradiation plus cyclosporine/mycophenolate mofetil followed by allo-HSCT or non-allo-HSCT consolidation therapy. 

  • The primary endpoint was LFS 

    • Restricted mean survival time was used to compare LFS 

  • Secondary endpoints were cumulative incidence (CI) of relapse, non-relapse mortality, and overall survival. 

Key findings1 

  • 125 patients were randomized; however, only 66 proceeded to allo-HSCT and 35 completed the full consolidation regimen. 

  • The primary endpoint of LFS was higher for patients treated with allo-HSCT vs those who were not (Figure 1). 

  • There was a significant difference of 8.9 months in the restricted mean LFS associated with allo-HSCT vs non-allo-HSCT (p=0.02). 

Figure 1. Survival endpoints for elderly patients treated with allo-HSCT vs non-allo-HSCT consolidation therapy* 

Allo-HSCT, allogeneic hematopoietic stem cell transplantation; LFS, leukemia-free survival; NRM, non-relapse mortality. 
*Adapted from Niederwieser.1 

  •  Overall survival was not statistically significant between the two study arms. 
  • The CI of Grade 24 acute graft vs host disease was 31.8%. 

  • The CI of limited and extensive chronic graft versus host disease was 45.5% and 33.5%, respectively. 

  • The main cause of death in the allo-HSCT and non-allo-HSCT groups was relapse (50.9% vs 100%). 

Key learnings 

  • Allo-HSCT was associated with an increased mean LFS vs non-allo-HSCT consolidation therapy in elderly patients with AML. 

  • Allo-HSCT also reduced the incidence of relapse vs non-allo-HSCT consolidation therapy. 

  • In contrast, non-relapse mortality was higher in patients after allo-HSCT vs non-allo-HSCT consolidation therapy. 

  1. Dietger Niederwieser. Hematopoietic cell transplantation for patients of older age with AML in first complete remission: Results from a randomized phase III trial of the EBMT. Oral abstract #OS1-02. 50th European Society for Blood and Marrow Transplantation Annual Meeting; April 15, 2024; Glasgow, UK. 


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