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

Qifa Liu²  Guopan Yu²  Xutao Guo²  Yonghua Li¹  Sanfang Tu⁴  Zhiping Fan²  Hongsheng Zhou²  Fen Huang²  Yu Zhang²  Danian Nie³  Yang Xiao¹  Jing Sun²  Zhaoyang Song⁴  Xiao Zhai²  Hui Liu² 

[1] Department of Hematology, Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, China;Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China;Department of Hematology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China;Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, China

关键词: Allogeneic hematopoietic stem cell transplantation;    Fludarabine;    Busulfan;   

Others  :  812612
DOI  :  10.1186/1756-8722-6-15

 received in 2012-12-02, accepted in 2013-02-03,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Liu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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