Prospective randomization of post-remission therapy comparing autologous peripheral blood stem cell transplantation versus high-dose cytarabine consolidation for acute myelogenous leukemia in first remission
Prospective randomization of post-remission therapy comparing autologous peripheral blood stem cell transplantation versus high-dose cytarabine consolidation for acute myelogenous leukemia in first remission
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DOI：
10.1007/s12185-017-2389-8
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发表时间：
2018-04-01
影响因子：
2.1
通讯作者：
Harada, Mine
中科院分区：
文献类型：
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作者：
Miyamoto, Toshihiro;Nagafuji, Koji;Harada, Mine
我们前瞻性地比较了自体干细胞移植（ASCT）与高剂量阿糖胞苷（HiDAC）巩固治疗作为首次完全缓解（CR1）中有利和中等风险急性髓性白血病（AML）的缓解后治疗的结果。招募了 240 名 65 岁以下的 AML-M1、M2、M4 或 M5 亚型患者。诱导后，153 名患者没有接受随机分组，而其余 87 名达到 CR1 的患者被前瞻性随机分配至 HiDAC（n = 45）或 ASCT 组（n = 42）。在 HiDAC 组中，43 名患者完成了三个周期的 HiDAC，而在 ASCT 组中，22 名患者完成了两个周期的巩固治疗，其中包括中等剂量阿糖胞苷加米托蒽醌或依托泊苷，然后进行 ASCT。 HiDAC 组的三年无病生存 (DFS) 率为 41%，ASCT 组的三年无病生存率为 55%（p = 0.25）。三年总生存率 (OS) 分别为 77% 和 68% (p = 0.67)。复发率分别为 54% 和 41% (p = 0.22)。两组之间的非复发死亡率没有显着差异（p = 0.88）。与 HiDAC 组的患者相比，ASCT 组的患者往往具有更高的 DFS 率和更低的复发率；然而，CR1 中的有利和中危 AML 患者的 OS 没有显着改善。 AML患者并不能从以ASCT为代表的强化化疗中获益。
We prospectively compared outcomes of autologous stem cell transplantation (ASCT) versus high-dose cytarabine (HiDAC) consolidation as post-remission therapy for favorable- and intermediate-risk acute myelogenous leukemia (AML) in first complete remission (CR1). Two-hundred-forty patients under 65 years with AML-M1, M2, M4, or M5 subtypes were enrolled. After induction, 153 patients did not undergo randomization, while the remaining 87 who achieved CR1 were prospectively randomized to HiDAC (n = 45) or ASCT arm (n = 42). In the HiDAC arm, 43 patients completed three cycles of HiDAC, whereas in ASCT arm 22 patients completed two cycles of consolidation consisting of intermediate-dose cytarabine plus mitoxantrone or etoposide followed by ASCT. The three-year disease-free survival (DFS) rate was 41% in HiDAC and 55% in ASCT arm (p = 0.25). Three-year overall survival (OS) rates were 77 and 68% (p = 0.67). Incidence of relapse was 54 and 41% (p = 0.22). There was no significant difference in nonrelapse mortality between two arms (p = 0.88). Patients in the ASCT arm tended to have higher DFS rates and lower relapse rates than patients in HiDAC; however, there was no significant improvement in OS in patients with favorable- and intermediate-risk AML in CR1. Patients with AML are not benefited by the intensified chemotherapy represented by ASCT.