Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison. - Université de Lille
Article Dans Une Revue Bone Marrow Transplantation Année : 2024

Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison.

Dietrich Wilhelm Beelen
  • Fonction : Auteur
Simona Iacobelli
  • Fonction : Auteur
Linda Koster
  • Fonction : Auteur
Dirk-Jan Eikema
  • Fonction : Auteur
Anja van Biezen
  • Fonction : Auteur
Friedrich Stölzel
  • Fonction : Auteur
Fabio Ciceri
  • Fonction : Auteur
Wolfgang Bethge
  • Fonction : Auteur
Peter Dreger
  • Fonction : Auteur
Eva-Maria Wagner-Drouet
  • Fonction : Auteur
Péter Reményi
  • Fonction : Auteur
Matthias Stelljes
  • Fonction : Auteur
Miroslaw Markiewicz
  • Fonction : Auteur
Donal P. Mclornan
  • Fonction : Auteur

Résumé

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.
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hal-04673691 , version 1 (23-08-2024)

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Dietrich Wilhelm Beelen, Simona Iacobelli, Linda Koster, Dirk-Jan Eikema, Anja van Biezen, et al.. Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison.. Bone Marrow Transplantation, 2024, Bone Marrow Transplantation, 59, pp.670-679. ⟨10.1038/s41409-024-02241-2⟩. ⟨hal-04673691⟩
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