Low-dose decitabine priming with intermediate-dose cytarabine followed by umbilical cord blood infusion as consolidation therapy for elderly patients with acute myeloid leukemia: a phase II single-arm study
Low-dose decitabine priming with intermediate-dose cytarabine followed by umbilical cord blood infusion as consolidation therapy for elderly patients with acute myeloid leukemia: a phase II single-arm study
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小剂量地西他滨联合中剂量阿糖胞苷启动，随后脐带血输注作为老年急性髓系白血病患者的巩固治疗：一项 II 期单臂研究
DOI：
10.1186/s12885-019-5975-8
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发表时间：
2019-08-20
期刊：
影响因子：
3.8
通讯作者：
Li, Junmin
中科院分区：
文献类型：
--
作者：
Li, Xiaoyang;Dong, Yuexin;Li, Junmin
背景老年急性髓细胞白血病（AML）的治疗仍是一个巨大的挑战.在这项前瞻性单组研究中，（ChiCTR-OPC-15006492），我们评估了低剂量地西他滨（LD-DAC）预充中剂量阿糖胞苷的新型巩固治疗的疗效和安全性（ID-Ara-C）随后脐带血（UCB）输注治疗老年AML患者。结果2年实际总生存率（OS）和无白血病生存率（LFS）分别为68.0%和60.0%。血液学和非血液学毒性为轻至中度，仅1例患者因感染可能的急性移植物抗宿主病（aGVHD）而在缓解期死亡。与同期接受常规巩固治疗的患者队列相比，研究组的OS和LFS往往有所改善（p= 0.046和0.057），而两组之间的毒性相当。结论本研究表明，LD DAC，ID Ara C和UCB输注的新组合可能是老年AML患者的最佳巩固治疗，试验注册这项在老年AML患者中进行的单组II期临床试验前瞻性注册于 www.chictr.org.cn （标识符： ChiCTR-OPC-15006492 ）2015年6月2日。
BackgroundTreatment of acute myeloid leukemia (AML) in elderly patients remains a great challenge. In this prospective single arm study (ChiCTR-OPC-15006492), we evaluated the efficacy and safety of a novel consolidation therapy with low-dose decitabine (LD-DAC) priming with intermediate-dose cytarabine (ID-Ara-C) followed by umbilical cord blood (UCB) infusion in elderly patients with AML.MethodsA total of 25 patients with a median age of 64-years-old (60–74-years-old) who achieved complete remission (CR) after induction chemotherapy were enrolled in the study.ResultsThe 2-year actual overall survival (OS) rate and leukemia-free survival (LFS) was 68.0 and 60.0%, respectively. The hematological and non-hematological toxicity were mild to moderate, and only one patient died in remission due to infection with possible acute graft versus host disease (aGVHD). Compared to a concurrent cohort of patients receiving conventional consolidation therapy, the study group tended to have an improved OS and LFS (p= 0.046 and 0.057, respectively), while the toxicity was comparable between the two groups.ConclusionsThis study suggested the novel combination of LD-DAC, ID-Ara-C, and UCB infusion might be an optimal consolidation therapy for elderly patients with AML, and a prospective phase III randomized study is warranted to confirm this observation.Trial registrationThis single-arm phase II clinical trial in elderly AML patients was registered prospectively at www.chictr.org.cn (identifier: ChiCTR-OPC-15006492 ) on June 2, 2015.