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三种剂量阿糖胞苷巩固治疗中高危急性髓系白血病的比较:来自泰国急性髓系白血病登记处的真实世界证据。

Comparison of Three Doses of Cytarabine Consolidation for Intermediate- and Adverse-risk Acute Myeloid Leukemia: Real World Evidence From Thai Acute Myeloid Leukemia Registry.

机构信息

Division of Hematology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Research Unit in Translational Hematology, Chulalongkorn University, Bangkok, Thailand.

Division of Hematology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand; Research Unit in Translational Hematology, Chulalongkorn University, Bangkok, Thailand.

出版信息

Clin Lymphoma Myeloma Leuk. 2022 Oct;22(10):e915-e921. doi: 10.1016/j.clml.2022.06.005. Epub 2022 Jun 12.

DOI:10.1016/j.clml.2022.06.005
PMID:35792033
Abstract

BACKGROUND

Intermediate or high doses of cytarabine (IDAC or HiDAC) were recommended as postremission chemotherapy for acute myeloid leukemia (AML). This retrospective study investigated the real-world outcomes of 3-different cytarabine doses from the multicenter Thai AML registry database.

PATIENTS AND METHODS

The intermediate- and adverse-risk AML patients (N = 258) who achieved complete remission and proceeded to single-agent cytarabine consolidation were enrolled.

RESULTS

The median relapse-free survival (RFS) using IDAC 1.5 g/m, high-dose cytarabine (HiDAC) 2 g/m, and HiDAC 3 g/m were 12.6, 11.7, and 13 months, respectively. The median overall survival (OS) using IDAC 1.5 g/m, HiDAC 2 g/m, and HiDAC 3 g/m were 34.9, 22.7, and 23.7 months, respectively. No significant difference in RFS and OS was detected between the 3 doses. Secondary AML, white blood cell > 100×10/L and the adverse-risk AML were independent prognostic factors for inferior survival (P= .008, P < .001, P= .014). Patients who completed 3 to 4 cycles of consolidation had significantly superior RFS and OS (P< .001, P< .001). Febrile neutropenia occurred in 72.9% of IDAC, 73.8% of HiDAC 2 g/m, and 78.1% of HiDAC 3 g/m without statistical significance. However, the incidence of septic shock was significantly higher after HiDAC 3 g/m compared to IDAC regimen (8% vs. 3%, P= .037).

CONCLUSION

IDAC is an appropriate regimen for postremission chemotherapy for intermediate- and adverse-risk AML. The higher dosing levels may not produce any benefits to patients and may increase incidence of septic shock. The number of consolidation cycles may impact on survivals rather than the intensity of cytarabine.

摘要

背景

中剂量或高剂量阿糖胞苷(IDAC 或 HiDAC)被推荐作为急性髓系白血病(AML)缓解后化疗。本回顾性研究从多中心泰国 AML 登记数据库调查了 3 种不同阿糖胞苷剂量的真实世界结局。

患者和方法

纳入 258 例达到完全缓解并接受单药阿糖胞苷巩固治疗的中危和高危 AML 患者。

结果

使用 IDAC 1.5 g/m²、高剂量阿糖胞苷(HiDAC)2 g/m²和 HiDAC 3 g/m²的中位无复发生存期(RFS)分别为 12.6、11.7 和 13 个月。使用 IDAC 1.5 g/m²、HiDAC 2 g/m²和 HiDAC 3 g/m²的中位总生存期(OS)分别为 34.9、22.7 和 23.7 个月。3 种剂量之间的 RFS 和 OS 无显著差异。继发性 AML、白细胞计数>100×10/L 和高危 AML 是生存不良的独立预后因素(P=0.008、P<0.001、P=0.014)。完成 3 至 4 个周期巩固治疗的患者具有显著更好的 RFS 和 OS(P<0.001、P<0.001)。IDAC 组、HiDAC 2 g/m²组和 HiDAC 3 g/m²组发热性中性粒细胞减少症的发生率分别为 72.9%、73.8%和 78.1%,无统计学意义。然而,HiDAC 3 g/m²组发生感染性休克的发生率明显高于 IDAC 方案组(8%比 3%,P=0.037)。

结论

IDAC 是中危和高危 AML 缓解后化疗的合适方案。更高的剂量水平可能对患者无益,并可能增加感染性休克的发生率。巩固治疗周期的数量可能对生存有影响,而不是阿糖胞苷的强度。

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