title: Tolerability and efficacy of busulfan and fludarabine as allogeneic pretransplant conditioning therapy in acute myeloid leukemia: comparison with busulfan and cyclophosphamide regimen.
abstract: BACKGROUND
  The aim of this study was to compare safety and efficacy of the association of busulfan with cyclophosphamide (BuCy2) versus busulfan and fludarabine (BuFlu) as a conditioning regimen in allogeneic hematopoietic progenitor cell transplantation (allo-HPCT) in patients with acute myeloid leukemia (AML).
  
  
  METHODS
  A total of 65 consecutive patients who received an allo-HPCT from Human Leucocyte Antigen-matched sibling donors were analyzed. The conditioning was BuCy2 in 48 patients and BuFlu in 17 patients.
  
  
  RESULTS
  There were no significant differences between the 2 cohorts in hematological engraftment, incidence of extrahematological toxicities, and acute graft versus host disease (GVHD). The incidence of chronic GVHD was 34% in the BuCy2 group versus 57% in the BuFlu group (P = .03). Transplant-related mortality was 17% (8 patients) in the BuCy2 group versus 0 in the BuFlu arm. Disease-related mortality was similar in the whole study population; in high-risk AML patients it was 11% in the BuCy2 group and 19% in the BuFlu group (P = .015). The probability of disease-free and event-free survival at 2 years was, respectively, 70% and 60% in the BuCy2 group and 59% and 58% in the BuFlu group (P = .06 and P = not significant [ns]). The probability of overall survival at 2 years was 71% in the BuCy2 group and 63% in the BuFlu group (P = ns), and in the high-risk group it was 83% and 67% in the BuCy2 and BuFlu group, respectively (P = ns).
  
  
  CONCLUSIONS
  BuFlu is well tolerated and is less toxic than BuCy2 and our results did not suggest that in high-risk AML, BuCy2 should be the favorite regimen in terms of efficacy.
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Fedele
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Messina
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Martinello
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Giuseppe Alberto
authors.initials: GA
authors.lastname: Gallo
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Pontari
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Moscato
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Console
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Antonia
authors.initials: A
authors.lastname: Dattola
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Domenica
authors.initials: D
authors.lastname: Princi
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Cuzzola
authors.affiliation: Hematology Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Alati
authors.affiliation: Hematology Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ronco
authors.affiliation: Oncology and Hematology Unit, Azienda Ospedaliera "Pugliese-Ciaccio," Catanzaro, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Irrera
authors.affiliation: Hematology and Stem Cell Transplantation Unit, Azienda Ospedaliera BMM, Reggio Calabria, Italy. Electronic address: dr.massimomartino@gmail.com.
authors.forename: Massimo
authors.initials: M
authors.lastname: Martino
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002066:Busulfan / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000517:prevention & control; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019172:Transplantation Conditioning / Q000009:adverse effects; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D055815:Young Adult
chemical_list: D003520:Cyclophosphamide; D014740:Vidarabine; D002066:Busulfan; C024352:fludarabine
keywords: Allogeneic transplantation; Busulfan; Conditioning regimen; Cyclophosphamide; Fludarabine