1. Tolerability and efficacy of busulfan and fludarabine as allogeneic pretransplant conditioning therapy in acute myeloid leukemia: comparison with busulfan and cyclophosphamide regimen.
- Author
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Fedele R, Messina G, Martinello T, Gallo GA, Pontari A, Moscato T, Console G, Dattola A, Princi D, Cuzzola M, Alati C, Ronco F, Molica S, Irrera G, and Martino M
- Subjects
- Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols adverse effects, Busulfan administration & dosage, Cyclophosphamide administration & dosage, Female, Graft vs Host Disease etiology, Graft vs Host Disease prevention & control, Humans, Leukemia, Myeloid, Acute mortality, Male, Middle Aged, Transplantation, Homologous, Treatment Outcome, Vidarabine administration & dosage, Vidarabine analogs & derivatives, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Hematopoietic Stem Cell Transplantation adverse effects, Leukemia, Myeloid, Acute therapy, Transplantation Conditioning adverse effects
- 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)., Patients and 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)., Conclusion: 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., (Copyright © 2014 Elsevier Inc. All rights reserved.)
- Published
- 2014
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