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

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 s...

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Published in:Bone marrow transplantation (Basingstoke) 2024-05, Vol.59 (5), p.670-679
Main Authors: Beelen, Dietrich Wilhelm, Iacobelli, Simona, Koster, Linda, Eikema, Dirk-Jan, van Biezen, Anja, Stölzel, Friedrich, Ciceri, Fabio, Bethge, Wolfgang, Dreger, Peter, Wagner-Drouet, Eva-Maria, Reményi, Péter, Stelljes, Matthias, Markiewicz, Miroslaw, McLornan, Donal P., Yakoub-Agha, Ibrahim, Mohty, Mohamad
Format: Article
Language:English
Subjects:
692/308/2779/109
692/700/565/2319
Acute myeloid leukemia
Allografts
Bone marrow
Bone marrow transplantation
Busulfan
Cell Biology
Clinical trials
Conditioning
Cyclophosphamide
Disease prevention
Drug dosages
Fludarabine
Hematology
Hematopoietic stem cells
Hospitals
Internal Medicine
Leukemia
Life Sciences
Medicine
Medicine & Public Health
Melphalan
Mortality
Myelodysplastic syndrome
Myelodysplastic syndromes
Oncology
Public Health
Pulmonology
Sensitivity analysis
Stem cell transplantation
Stem Cells
Toxicity
Transplantation
Treosulfan
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Summary: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  
ISSN:0268-3369
1476-5365
1476-5365
DOI:10.1038/s41409-024-02241-2