白消安联合氟达拉滨与白消安联合环磷酰胺用于急性髓系白血病异基因造血干细胞移植的毒性和疗效比较

[A comparison of toxicity and efficacy between busulfan plus fludarabine and busulfan plus cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia].

作者信息

Liu Hui, Fan Zhi-ping, Jiang Qian-li, Huang Fen, Zhou Hong-sheng, Zhang Xian, Yu Guo-pan, Wu Mei-qing, Sun Jing, Liu Qi-fa

机构信息

Institute of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou 510515, China.

出版信息

Zhonghua Nei Ke Za Zhi. 2012 Nov;51(11):880-4.

PMID:23291027

Abstract

OBJECTIVE

To compare the transplant-related toxicity and the efficacy of busulfan/fludarabine (Bu/Flu) and busulfan/cyclophosphamide (Bu/Cy) as conditioning regimen in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia(AML) in the first complete remission (CR1).

METHODS

Totally 32 AML-CR1 patients underwent allo-HSCT were divided into Bu/Cy (Bu 3.2 mg×kg(-1)×d(-1), 7 - 4 days before transplantation; Cy 60 mg×kg(-1)×d(-1), 3 - 2 days before transplantation) and Bu/Flu (Bu 3.2 mg×kg(-1)×d(-1), 5 - 2 days before transplantation; Flu 30 mg×m(-2)×d(-1), 6 - 2 days before transplantation) groups. The regimen-related toxicity (RRT), incidence and severity of graft-versus-host disease (GVHD), 3-year cumulative relapse rate, non-relapse mortality (NRM), 3-year event-free survival (EFS) rate and overall survival (OS) rate were compared between the two groups.

RESULTS

The median follow-up duration was 617.5 (6 - 1261) days. All patients achieved successful engraftment on 30 day after transplantation. There were no significant differences in the median time to neutrophil engraftment (P = 0.121) and platelet engraftment (P = 0.171) between the two groups. The median duration of neutrophil count under 0.1×10(9)/L and platelet count under 20×10(9)/L in the Bu/Cy group were significantly longer than those in the Bu/Flu group (P = 0.000 and P = 0.047). The incidence of grades II-IV RRT were 68.8% and 25.0% (P = 0.032) in the Bu/Cy and the Bu/Flu groups, respectively. There were no significant differences in the incidence of acute GVHD (P = 0.149), chronic GVHD (P = 0.149), incidence of NRM (P = 0.333), 3-year cumulative relapse rates (P = 0.834), 3-year EFS rate (P = 0.362) and OS rate (P = 0.111) between the two groups.

CONCLUSION

Compared with Bu/Cy, Bu/Flu is a myeloablative condition regimen with milder bone marrow suppression and lower RRT incidence rate in allogeneic HSCT for AML-CR1 patients without compromising the efficacy.

摘要

目的

比较白消安/氟达拉滨（Bu/Flu）和白消安/环磷酰胺（Bu/Cy）作为预处理方案在急性髓系白血病（AML）首次完全缓解期（CR1）进行异基因造血干细胞移植（allo-HSCT）时的移植相关毒性及疗效。

方法

将32例行allo-HSCT的AML-CR1患者分为Bu/Cy组（白消安3.2mg×kg⁻¹×d⁻¹，移植前7至4天；环磷酰胺60mg×kg⁻¹×d⁻¹，移植前3至2天）和Bu/Flu组（白消安3.2mg×kg⁻¹×d⁻¹，移植前5至2天；氟达拉滨30mg×m⁻²×d⁻¹，移植前6至2天）。比较两组的方案相关毒性（RRT）、移植物抗宿主病（GVHD）的发生率及严重程度、3年累积复发率、非复发死亡率（NRM）、3年无事件生存率（EFS）率和总生存率（OS）率。

结果

中位随访时间为617.5（6至1261）天。所有患者均在移植后30天成功植入。两组中性粒细胞植入中位时间（P = 0.121）和血小板植入中位时间（P = 0.171）无显著差异。Bu/Cy组中性粒细胞计数低于0.1×10⁹/L和血小板计数低于20×10⁹/L的中位持续时间显著长于Bu/Flu组（P = 0.000和P = 0.047）。Bu/Cy组和Bu/Flu组II-IV级RRT的发生率分别为68.8%和25.0%（P = 0.032）。两组急性GVHD发生率（P = 0.149）、慢性GVHD发生率（P = 0.149）、NRM发生率（P = 0.333）、3年累积复发率（P = 0.834）、3年EFS率（P = 0.362）和OS率（P = 0.111）无显著差异。