Fludarabine-treosulfan versus fludarabine-melphalan or busulfan-cyclophosphamide conditioning in older AML or MDS patients - A clinical trial to registry data comparison.
Dietrich Wilhelm BeelenSimona IacobelliLinda KosterDirk-Jan EikemaAnja van BiezenFriedrich StölzelFabio CiceriWolfgang Andreas BethgePeter DregerEva Maria Wagner-DrouetPéter ReményiMatthias StelljesMiroslaw MarkiewiczDonal P McLornanIbrahim Yakoub-AghaFlorent MalardPublished in: Bone marrow transplantation (2024)
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.
Keyphrases
- end stage renal disease
- acute myeloid leukemia
- ejection fraction
- clinical trial
- chronic kidney disease
- newly diagnosed
- prognostic factors
- prostate cancer
- randomized controlled trial
- peritoneal dialysis
- high dose
- low dose
- cardiovascular disease
- type diabetes
- patient reported outcomes
- allogeneic hematopoietic stem cell transplantation
- coronary artery disease
- machine learning
- stem cells
- mesenchymal stem cells
- artificial intelligence
- acute lymphoblastic leukemia
- electronic health record
- big data
- open label
- radical prostatectomy
- cell proliferation
- clinical evaluation
- free survival