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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.
J Hematol Oncol. 2013 Feb 08; 6:15.JH

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.

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.

Authors+Show Affiliations

Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23394705

Citation

Liu, Hui, et al. "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." Journal of Hematology & Oncology, vol. 6, 2013, p. 15.
Liu H, Zhai X, Song Z, et al. 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. J Hematol Oncol. 2013;6:15.
Liu, H., Zhai, X., Song, Z., Sun, J., Xiao, Y., Nie, D., Zhang, Y., Huang, F., Zhou, H., Fan, Z., Tu, S., Li, Y., Guo, X., Yu, G., & Liu, Q. (2013). 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. Journal of Hematology & Oncology, 6, 15. https://doi.org/10.1186/1756-8722-6-15
Liu H, et al. 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. J Hematol Oncol. 2013 Feb 8;6:15. PubMed PMID: 23394705.
* Article titles in AMA citation format should be in sentence-case
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 -