title: Allogeneic hematopoietic SCT in patients with AML following treosulfan/fludarabine conditioning.
abstract: An alternative reduced-toxicity conditioning regimen for allogeneic transplantation, based on treosulfan and fludarabine, has recently been identified. The safety and efficacy of this new conditioning regimen has been investigated prospectively in patients with AML. A total number of 75 patients with AML in CR were treated with 3 × 14 g/m(2) treosulfan and 5 × 30 mg/m(2) fludarabine, followed by matched sibling or unrelated SCT. Patients were evaluated for engraftment, adverse events, GVHD, and for non-relapse mortality, relapse incidence, overall and disease-free survival (DFS). All patients showed primary engraftment of neutrophils after a median of 20 days. Non-hematological adverse events grade III-IV in severity included mainly infections (59%) and gastrointestinal symptoms (7%). Acute GVHD grade II-IV occurred in 21% and extensive chronic GVHD occurred in 16% of the patients. After a median follow-up of 715 days, the 2-year overall and DFS estimates were 61% and 55%, respectively. The 2-year incidences of relapse and non-relapse mortality reached 34% and 11%, respectively. In summary, our data confirm promising safety and efficacy of the treosulfan-based conditioning therapy in AML patients, ClinicalTrials.gov Identifier: NCT01063660.
authors.affiliation: Division of Hematology and Oncology, University of Rostock, Rostock, Germany. casper.jochen@klinikum-oldenburg.de
authors.forename: J
authors.initials: J
authors.lastname: Casper
authors.forename: J
authors.initials: J
authors.lastname: Holowiecki
authors.forename: R
authors.initials: R
authors.lastname: Trenschel
authors.forename: H
authors.initials: H
authors.lastname: Wandt
authors.forename: K
authors.initials: K
authors.lastname: Schaefer-Eckart
authors.forename: T
authors.initials: T
authors.lastname: Ruutu
authors.forename: L
authors.initials: L
authors.lastname: Volin
authors.forename: H
authors.initials: H
authors.lastname: Einsele
authors.forename: G
authors.initials: G
authors.lastname: Stuhler
authors.forename: L
authors.initials: L
authors.lastname: Uharek
authors.forename: I
authors.initials: I
authors.lastname: Blau
authors.forename: M
authors.initials: M
authors.lastname: Bornhaeuser
authors.forename: A R
authors.initials: AR
authors.lastname: Zander
authors.forename: K
authors.initials: K
authors.lastname: Larsson
authors.forename: M
authors.initials: M
authors.lastname: Markiewicz
authors.forename: S
authors.initials: S
authors.lastname: Giebel
authors.forename: T
authors.initials: T
authors.lastname: Kruzel
authors.forename: H A
authors.initials: HA
authors.lastname: Mylius
authors.forename: J
authors.initials: J
authors.lastname: Baumgart
authors.forename: U
authors.initials: U
authors.lastname: Pichlmeier
authors.forename: M
authors.initials: M
authors.lastname: Freund
authors.forename: D W
authors.initials: DW
authors.lastname: Beelen
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002066:Busulfan / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods*; D014184:Transplantation, Homologous; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D055815:Young Adult
chemical_list: C018404:treosulfan; D014740:Vidarabine; D002066:Busulfan; C024352:fludarabine