Fludarabine, melphalan, and alemtuzumab conditioning in adults with standard-risk advanced acute myeloid leukemia and myelodysplastic syndrome. Academic Article uri icon

Overview

abstract

  • PURPOSE: This prospective phase II study evaluated toxicity, relapse rate, progression-free survival, and overall survival after allogeneic transplantation and conditioning with fludarabine, melphalan, and alemtuzumab in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). PATIENTS AND METHODS: Fifty-two consecutive adults with AML and MDS were enrolled onto the study. Median age was 52 years (range, 17 to 71 years) and the majority of patients had high-risk disease, comorbidities, and/or modest reduction in performance status. Fifty-six percent of patients had unrelated or mismatched related donors. RESULTS: After a median follow-up of 18 months (range, 2 to 34 months), 1-year survival was 48% (95% CI, 34% to 61%), progression-free survival was 38% (95% CI, 25% to 52%), relapse rate was 27% (95% CI, 15% to 40%), and treatment-related mortality was 33% (95% CI, 20% to 46%). The cumulative probability of extensive chronic graft-versus-host disease (GVHD) was only 18% (95% CI, 8% to 40%); extensive chronic GVHD was only observed in recipients of unrelated donor transplants. Performance score and disease status were the major predictors of outcome. High-risk disease (ie, active AML or MDS with > 5% blasts) or even modest decreases in performance status were associated with poor outcomes. Patients with standard-risk leukemia (first or second complete remission) or MDS (< 5% blasts) had excellent outcomes despite unfavorable disease characteristics. CONCLUSION: Fludarabine and melphalan combined with in vivo alemtuzumab is a promising transplantation regimen for patients with AML or MDS and low tumor burden. For patients with active disease, this regimen provides at best modest palliation. Despite a low incidence of GVHD, transplantation is still associated with considerable nonrelapse mortality in patients with decreased performance status.

authors

  • Van Besien, Koen
  • Artz, A
  • Smith, S
  • Cao, D
  • Rich, S
  • Godley, L
  • Jones, D
  • Del Cerro, P
  • Bennett, D
  • Casey, B
  • Odenike, O
  • Thirman, M
  • Daugherty, C
  • Wickrema, A
  • Zimmerman, T
  • Larson, R A
  • Stock, W

publication date

  • July 11, 2005

Research

keywords

  • Antineoplastic Combined Chemotherapy Protocols
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Stem Cell Transplantation
  • Transplantation Conditioning

Identity

Scopus Document Identifier

  • 24944582579

PubMed ID

  • 16009946

Additional Document Info

volume

  • 23

issue

  • 24