title: De novo acute myeloid leukemia with multilineage dysplasia: treatment results and prognostic evaluation from a series of 44 patients treated with fludarabine, cytarabine and G-CSF (FLAG).
abstract: OBJECTIVE
  To evaluate therapeutic results and prognostic factors from a series of 44 patients affected by de novo acute myeloid leukemia with multilineage dysplasia (MD-AML), treated with the combination of fludarabine, cytarabine and G-CSF (FLAG).
  
  
  METHODS
  Forty-four patients with de novo MD-AML were treated with the FLAG regimen. The median age was 61 yr (range 31-75 yr). Induction therapy consisted of the FLAG regimen; consolidation included idarubicin plus cytarabine. Patients with a compatible donor and aged less than 55 yr were programmed to receive allogeneic bone marrow transplantation (BMT), while in those without a donor and aged less than 65 yr autologous transplantation with peripheral blood stem cells mobilized by a consolidation regimen plus G-CSF was planned. Bone marrow harvest was performed in poor mobilizers.
  
  
  RESULTS
  Complete remission (CR) was achieved in 28 out of 44 patients (64%). Death in induction occurred in four patients (9%), while 12 patients (27%) were resistant to FLAG. Toxicity of consolidation was negligible. Most patients aged less than 60 yr and achieving CR were eligible for transplantation procedures, the main reason of exclusion being early relapse. Median overall survival and disease free survival were 16 and 22 months, respectively. Unfavorable cytogenetics was the only parameter significantly related to inferior clinical outcome following multivariate analysis.
  
  
  CONCLUSIONS
  Multilineage dysplasia per se is not an adverse prognostic factor in AML patients treated with the FLAG regimen. Favorable results are obtained in patients with intermediate karyotype, while in those with adverse cytogenetics new approaches are clearly needed. The toxicity of the regimen is also acceptable in the elderly, and following induction/consolidation, most patients may be submitted to transplantation procedures.
authors.affiliation: Hematology Division, A.O.R.N. A Cardarelli, Naples, Italy. felicettoferrara@katamail.com
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Salvatore
authors.initials: S
authors.lastname: Palmieri
authors.forename: Barbara
authors.initials: B
authors.lastname: Pocali
authors.forename: Filiberto
authors.initials: F
authors.lastname: Pollio
authors.forename: Assunta
authors.initials: A
authors.lastname: Viola
authors.forename: Silvana
authors.initials: S
authors.lastname: Annunziata
authors.forename: Lucia
authors.initials: L
authors.lastname: Sebastio
authors.forename: Ettore Mariano
authors.initials: EM
authors.lastname: Schiavone
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Mele
authors.forename: Giacomo
authors.initials: G
authors.lastname: Gianfaldoni
authors.forename: Franco
authors.initials: F
authors.lastname: Leoni
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016026:Bone Marrow Transplantation; D019070:Cell Lineage; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D007951:Leukemia, Myeloid / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016019:Survival Analysis; D014184:Transplantation, Homologous; D014740:Vidarabine / Q000008:administration & dosage* / Q000031:analogs & derivatives
chemical_list: D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D014740:Vidarabine