title: Busulfan plus fludarabine as a myeloablative conditioning regimen compared with busulfan plus cyclophosphamide for acute myeloid leukemia in first complete remission undergoing allogeneic hematopoietic stem cell transplantation: a prospective and multicenter study.
abstract: OBJECTIVE
  We conducted a prospective, randomized, open-label, multicenter study to compare busulfan plus fludarabine (BuFlu) with busulfan plus cyclophosphamide (BuCy) as the conditioning regimen in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia (AML) in first complete remission (CR1).
  
  
  METHODS
  Totally 108 AML-CR1 patients undergoing allo-HSCT were randomized into BuCy (busulfan 1.6 mg/kg, q12 hours, -7 ~ -4d; cyclophosphamide 60 mg/kg.d, -3 ~ -2d) or BuFlu (busulfan 1.6 mg/kg, q12 hours, -5 ~ -2d; fludarabine 30 mg/m2.d, -6 ~ -2d) group. Hematopoietic engraftment, regimen-related toxicity (RRT), graft-versus-host disease (GVHD), transplant related mortality (TRM), and overall survival were compared between the two groups.
  
  
  RESULTS
  All patients achieved hematopoietic reconstitution except for two patients who died of RRT during conditioning. All patients obtained complete donor chimerism by day +30 post-transplantation. The incidence of total and III-IV RRT were 94.4% and 81.5% (P = 0.038), and 16.7% and 0.0% (P = 0.002), respectively, in BuCy and BuFlu group. With a median follow up of 609 (range, 3-2130) days after transplantation, the 5-year cumulative incidence of TRM were 18.8 ± 6.9% and 9.9 ± 6.3% (P = 0.104); the 5-year cumulative incidence of leukemia relapse were 16.5 ± 5.8% and 16.2 ± 5.3% (P = 0.943); the 5-year disease-free survival and overall survival were 67.4 ± 7.6% and 75.3 ± 7.2% (P = 0.315), and 72.3 ± 7.5% and 81.9 ± 7.0% (P = 0.177), respectively in BuCy and BuFlu group.
  
  
  CONCLUSIONS
  Compared with BuCy, BuFlu as a myeloablative condition regimen was associated with lower toxicities and comparable anti-leukemic activity in AML-CR1 patients undergoing allo-HSCT.
authors: Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
authors: Hui
authors: H
authors: Liu
authors: Xiao
authors: X
authors: Zhai
authors: Zhaoyang
authors: Z
authors: Song
authors: Jing
authors: J
authors: Sun
authors: Yang
authors: Y
authors: Xiao
authors: Danian
authors: D
authors: Nie
authors: Yu
authors: Y
authors: Zhang
authors: Fen
authors: F
authors: Huang
authors: Hongsheng
authors: H
authors: Zhou
authors: Zhiping
authors: Z
authors: Fan
authors: Sanfang
authors: S
authors: Tu
authors: Yonghua
authors: Y
authors: Li
authors: Xutao
authors: X
authors: Guo
authors: Guopan
authors: G
authors: Yu
authors: Qifa
authors: Q
authors: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002066:Busulfan / Q000008:administration & dosage; D002648:Child; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000401:mortality* / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000401:mortality* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D012307:Risk Factors; D015996:Survival Rate; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D055815:Young Adult
chemical_list: D003520:Cyclophosphamide; D014740:Vidarabine; D002066:Busulfan; C024352:fludarabine
references: Blood. 2002 Nov 15;100(10):3843-4
references: 12411329
references: Leukemia. 2010 May;24(5):1050-2
references: 20147978
references: Bone Marrow Transplant. 2013 Mar;48(3):383-9
references: 23000651
references: Cancer Control. 2011 Oct;18(4):268-76
references: 21976245
references: Bone Marrow Transplant. 2008 Jun;41(11):935-40
references: 18264144
references: Blood. 2004 Aug 1;104(3):857-64
references: 15073038
references: Bone Marrow Transplant. 2007 Sep;40(6):541-7
references: 17637692
references: Biol Blood Marrow Transplant. 2009 Nov;15(11):1376-85
references: 19822296
references: Biol Blood Marrow Transplant. 2009 May;15(5):523-36
references: 19361744
references: Exp Hematol Oncol. 2012 May 18;1(1):13
references: 23210643
references: Biol Blood Marrow Transplant. 2002;8(9):468-76
references: 12374451
references: Blood Rev. 2006 Jan;20(1):15-27
references: 16426941
references: Korean J Hematol. 2010 Jun;45(2):102-8
references: 21120188
references: Blood. 2004 Aug 1;104(3):865-72
references: 15090449
references: J Hematol Oncol. 2012 Aug 02;5:46
references: 22856463
references: Biol Blood Marrow Transplant. 2012 Jan;18(1 Suppl):S17-26
references: 22226102
references: Blood. 2003 Mar 1;101(5):2043-8
references: 12406916
references: N Engl J Med. 2006 Apr 27;354(17):1813-26
references: 16641398
references: Bone Marrow Transplant. 2007 Jul;40(2):105-10
references: 17468775
references: J Clin Oncol. 1988 Oct;6(10):1562-8
references: 3049951
references: J Natl Compr Canc Netw. 2012 Aug;10(8):984-1021
references: 22878824
references: J Clin Oncol. 2013 Feb 20;31(6):701-9
references: 23129746
references: Biol Blood Marrow Transplant. 2013 Feb;19(2):283-90
references: 23063629
references: Bone Marrow Transplant. 1995 Jun;15(6):825-8
references: 7581076
references: Leukemia. 2006 Feb;20(2):322-8
references: 16307018
references: J Hematol Oncol. 2010 Oct 06;3:36
references: 20925957
references: Biol Blood Marrow Transplant. 2008 Jun;14(6):672-84
references: 18489993
references: Biol Blood Marrow Transplant. 2003 Jan;9(1):52-9
references: 12533742
references: Bone Marrow Transplant. 2001 Mar;27(5):499-505
references: 11313683
references: Br J Haematol. 1999 Dec;107(4):877-82
references: 10606897