151. Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison.
- Author
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Beelen DW, Iacobelli S, Koster L, Eikema DJ, van Biezen A, Stölzel F, Ciceri F, Bethge W, Dreger P, Wagner-Drouet EM, Reményi P, Stelljes M, Markiewicz M, McLornan DP, Yakoub-Agha I, and Mohty M
- Subjects
- Humans, Aged, Middle Aged, Female, Male, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Hematopoietic Stem Cell Transplantation methods, Busulfan analogs & derivatives, Busulfan therapeutic use, Busulfan administration & dosage, Busulfan pharmacology, Vidarabine analogs & derivatives, Vidarabine therapeutic use, Vidarabine pharmacology, Vidarabine administration & dosage, Leukemia, Myeloid, Acute therapy, Leukemia, Myeloid, Acute drug therapy, Leukemia, Myeloid, Acute mortality, Myelodysplastic Syndromes therapy, Myelodysplastic Syndromes mortality, Myelodysplastic Syndromes drug therapy, Cyclophosphamide therapeutic use, Cyclophosphamide administration & dosage, Cyclophosphamide pharmacology, Transplantation Conditioning methods, Registries, Melphalan therapeutic use, Melphalan administration & dosage, Melphalan pharmacology
- Abstract
A randomized study (acronym: MC-FludT.14/L Trial II) demonstrated that fludarabine plus treosulfan (30 g/m²) was an effective and well tolerated conditioning regimen for allogeneic hematopoietic cell transplantation (allo-HCT) in older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). To further evaluate this regimen, all 252 study patients aged 50 to 70 years were compared with similar patients, who underwent allo-HCT after fludarabine/melphalan (140 mg/m²) (FluMel) or busulfan (12.8 mg/kg)/cyclophosphamide (120 mg/kg) (BuCy) regimens and whose data was provided by the European Society for Blood and Marrow Transplantation registry. In 1:1 propensity-score matched-paired analysis (PSA) of AML patients, there was no difference in 2-year-relapse-incidence after FluTreo compared with either FluMel (n = 110, p = 0.28) or BuCy (n = 78, p = 0.98). However, 2-year-non-relapse-mortality (NRM) was lower compared with FluMel (p = 0.019) and BuCy (p < 0.001). Consequently, 2-year-overall-survival (OS) after FluTreo was higher compared with FluMel (p = 0.04) and BuCy (p < 0.001). For MDS patients, no endpoint differences between FluTreo and FluMel (n = 30) were evident, whereas 2-year-OS after FluTreo was higher compared with BuCy (n = 25, p = 0.01) due to lower 2-year-NRM. Multivariate sensitivity analysis confirmed all significant results of PSA. Consequently, FluTreo (30 g/m²) seems to retain efficacy compared with FluMel and BuCy, but is better tolerated by older patients., (© 2024. The Author(s).)
- Published
- 2024
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