title: Toxicity and efficacy of busulfan and fludarabine myeloablative conditioning for HLA-identical sibling allogeneic hematopoietic cell transplantation in AML and MDS.
abstract: The safety and efficacy of a 4-day myeloablative conditioning (MAC) regimen consisting of Bu 3.2 mg/kg and fludarabine 40 mg/m(2)/day for HLA-identical sibling allogeneic hematopoietic cell transplantation (HCT) in myeloid malignancies was investigated in 133 patients (median age, 47 years; range 19-74 years) with de novo AML (60%), secondary AML (20%) or myelodysplastic syndrome (20%). All patients engrafted. Hepatic veno-occlusive disease occurred in five patients (4%), and severe toxicities, mostly mucositis, occurred in twenty-three (17%) patients. The non-relapse mortality (NRM) at 100 days was 1.5%. The incidences of acute GVHD grade 2-4 and grade 3-4 were 32 and 13%, respectively. At a median follow-up of 38 months, the cumulative incidence of chronic GVHD was 67%. The relapse incidence was 30% (27 and 31%, respectively, in patients with early- and late-stage disease), and the overall NRM was 15%. The actuarial 4-year disease-free survival (DFS) and overall survival (OS) were 54 and 62%, respectively. Patients aged <50 years had better outcomes compared with older patients (DFS 64 vs 42%, P=0.006; OS 73 vs 47%, P<0.001, respectively).
authors.affiliation: Hematology Department, Servicio de Hematología, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: De La Serna
authors.affiliation: Hematology Department, Hospital Universitario La Fe, Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Sanz
authors.affiliation: Hematology Department, Hospital Universitario Marques de Valdecilla, Santander, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Bermúdez
authors.affiliation: Hematology Department, Hospital Universitario Clínico de Salamanca, Salamanca, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Cabrero
authors.affiliation: Hematology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Serrano
authors.affiliation: Hematology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Vallejo
authors.affiliation: Hematology Department, Hospital Universitario de la Princesa, Madrid, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Gómez
authors.affiliation: Hematology Department, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Moraleda
authors.affiliation: Hematology Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: S G
authors.initials: SG
authors.lastname: Perez
authors.affiliation: Hematology Department, Hospital Universitario Clínico de Salamanca, Salamanca, Spain.
authors.forename: M D
authors.initials: MD
authors.lastname: Caballero
authors.affiliation: Hematology Department, Hospital Universitario Marques de Valdecilla, Santander, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Conde
authors.affiliation: Hematology Department, Servicio de Hematología, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: J J
authors.initials: JJ
authors.lastname: Lahuerta
authors.affiliation: Hematology Department, Hospital Universitario La Fe, Valencia, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Sanz
mesh_terms: D000328:Adult; D000368:Aged; D002066:Busulfan / Q000008:administration & dosage* / Q000633:toxicity; D006086:Graft vs Host Disease / Q000209:etiology; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006504:Hepatic Veno-Occlusive Disease / Q000139:chemically induced / Q000209:etiology; D006648:Histocompatibility / Q000276:immunology; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000150:complications / Q000401:mortality / Q000628:therapy*; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced / Q000209:etiology; D019653:Myeloablative Agonists / Q000627:therapeutic use / Q000633:toxicity*; D009190:Myelodysplastic Syndromes / Q000150:complications / Q000401:mortality / Q000628:therapy*; D012008:Recurrence; D016019:Survival Analysis; D019172:Transplantation Conditioning / Q000379:methods* / Q000401:mortality; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D055815:Young Adult
chemical_list: D019653:Myeloablative Agonists; D014740:Vidarabine; D002066:Busulfan; C024352:fludarabine