TY - JOUR T1 - 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. AU - Liu,Hui, AU - Zhai,Xiao, AU - Song,Zhaoyang, AU - Sun,Jing, AU - Xiao,Yang, AU - Nie,Danian, AU - Zhang,Yu, AU - Huang,Fen, AU - Zhou,Hongsheng, AU - Fan,Zhiping, AU - Tu,Sanfang, AU - Li,Yonghua, AU - Guo,Xutao, AU - Yu,Guopan, AU - Liu,Qifa, Y1 - 2013/02/08/ PY - 2012/12/02/received PY - 2013/02/03/accepted PY - 2013/2/12/entrez PY - 2013/2/12/pubmed PY - 2013/7/26/medline SP - 15 EP - 15 JF - Journal of hematology & oncology JO - J Hematol Oncol VL - 6 N2 - 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. CONCLUSION: 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. SN - 1756-8722 UR - https://www.unboundmedicine.com/medline/citation/23394705/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_ L2 - https://jhoonline.biomedcentral.com/articles/10.1186/1756-8722-6-15 DB - PRIME DP - Unbound Medicine ER -