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Allo-HSCT vs consolidation therapy to improve leukemia-free survival in elderly patients with AML
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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
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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.
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The primary endpoint was LFS
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Restricted mean survival time was used to compare LFS
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Secondary endpoints were cumulative incidence (CI) of relapse, non-relapse mortality, and overall survival.
Key findings1
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125 patients were randomized; however, only 66 proceeded to allo-HSCT and 35 completed the full consolidation regimen.
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The primary endpoint of LFS was higher for patients treated with allo-HSCT vs those who were not (Figure 1).
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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.
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The CI of Grade 2–4 acute graft vs host disease was 31.8%.
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The CI of limited and extensive chronic graft versus host disease was 45.5% and 33.5%, respectively.
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The main cause of death in the allo-HSCT and non-allo-HSCT groups was relapse (50.9% vs 100%).
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Key learnings |
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- 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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