Reduced-intensity conditioning with fludarabine and busulfan versus fludarabine and melphalan for patients with acute myeloid leukemia: A report from the Acute Leukemia Working Party of the European Group for Blood and Marrow Transplantation

Frédéric Baron, Myriam Labopin, Andy Peniket, Pavel Jindra, Boris Afanasyev, Miguel A. Sanz, Eric Deconinck, Arnon Nagler, Mohamad Mohty

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND Fludarabine plus busulfan (FB) and fludarabine plus melphalan (FM) are 2 widely used reduced-intensity conditioning (RIC) regimens for allogeneic hematopoietic stem cell transplantation (allo-SCT). METHODS The current survey compared transplantation outcomes for a cohort of 394 acute myeloid leukemia (AML) patients given bone marrow or peripheral blood stem cells from human leukocyte antigen-identical siblings after FB (n = 218) or FM (n = 176). Patients given manipulated grafts and those given T-cell-depleting agents (anti-thymocyte globulins or alemtuzumab) were not included. RESULTS At the time of transplantation, 266 patients (68%) were experiencing their first complete remission (CR), 69 (18%) were experiencing a later CR, and 59 (15%) had advanced disease. The incidences of acute and chronic graft-versus-host disease were similar in the 2 groups of patients. The 2-year relapse incidence (RI), nonrelapse mortality (NRM) rate, leukemia-free survival (LFS) rate, and overall survival (OS) rate were 31% ± 3%, 18% ± 3%, 51% ± 4%, and 54% ± 4%, respectively, for FB patients and 20% ± 3% (P = .007), 20% ± 3% (P = .4), 60% ± 4% (P = .08), and 62% ± 4% (P = .2), respectively, for FM patients. Among FB patients given intravenous busulfan (n = 81), the 2-year RI, NRM, LFS, and OS rates were 26% ± 5% (P = .43 vs FM patients), 25% ± 6% (P = .18), 49% ± 7% (P = .07), and 54% ± 7% (P = .13), respectively. In multivariate analyses, FM was associated with a lower RI (hazard ratio [HR], 0.5; P = .01) and a trend toward higher NRM (HR, 1.6; P = .1) with similar LFS (HR, 0.8; P = .2) and OS (HR, 0.9; P = .6). CONCLUSIONS These results suggest that although FM provides better AML control than FB as an RIC regimen for allo-SCT, the 2 regimens provide similar survival. Multicenter randomized studies are needed to confirm these findings. Cancer 2015;121:1048-1055.

Original languageEnglish
Pages (from-to)1048-1055
Number of pages8
JournalCancer
Volume121
Issue number7
DOIs
StatePublished - 1 Apr 2015

Keywords

  • acute myeloid leukemia (AML)
  • busulfan
  • fludarabine
  • graft-versus-host disease (GVHD)
  • melphalan
  • reduced-intensity conditioning (RIC)
  • transplantation

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