Objective: To investigate the efficacy and prognosis of CLAG±DAC (Clofarabine, Cytarabine, G-CSF±Decitabine) chemotherapy in patients with relapsed/refractory acute myeloid leukemia (R/R AML) . Methods: Continuous cases of R/R AML treated with the CLAG+DAC protocol or CLAG alone at the First Affiliated Hospital of Soochow University from January 2017 to December 2021 were retrospectively analyzed. The baseline characteristics, individual treatment regimen, treatment effect, disease progression, and survival status of patients were recorded. The factors influencing the efficacy of the CLAG±DAC chemotherapy regimens were analyzed, and the overall survival (OS) time after reinduction was calculated using the Kaplan-Meier method. Results: This study included a total of 53 patients, with 33 male patients and an average age of 40.6 years. Thirty-three patients achieved complete remission (CR+CRi) of the disease after the CLAG±DAC chemotherapy regimen and six patients achieved partial remission (PR), while 14 did not. Thirty-two patients eventually underwent hematopoietic stem cell transplantation, and the median OS of the patients was 55.9 months until follow-up. Patients with disease remission after the application of the CLAG±DAC chemotherapy had a significantly longer survival time than those without remission (P<0.001). The results of the multifactorial analysis have revealed that combined DAC (OR=4.60, 95% CI 1.14-23.5, P=0.04) and DNMT3A mutation (OR=0.14, 95% CI 0.01-0.89, P=0.05) were the factors influencing the efficacy of the CLAG±DAC chemotherapy regimen. The remission rate was relatively higher in patients with R/R AML combined with FLT3-ITD mutation by applying the DAC+CLAG regimen (OR=10.84, 95%CI 1.48-288.50, P=0.04) . Conclusion: The CLAG±DAC regimen is considered effective in patients with R/R AML, whereas decitabine combined with the CLAG regimen is more suitable for patients with R/R AML combined with FLT3-ITD mutation.
目的： 探讨CLAG（克拉屈滨、阿糖胞苷、G-CSF）±地西他滨（DAC）方案对难治复发性急性髓系白血病（R/R AML）的疗效及其影响因素。 方法： 回顾性分析2017年1月至2021年12月苏州大学附属第一医院收治的应用CLAG+DAC或单纯CLAG方案治疗的R/R AML病例，收集患者的基本特征、个体化治疗方案、治疗反应、疾病进展和生存状态。分析影响CLAG±DAC化疗方案疗效的因素，并采用Kaplan-Meier方法计算总生存（OS）期。 结果： 共纳入53例患者，男性患者33例，患者平均年龄为40.6岁。33例患者在CLAG±DAC方案化疗1个疗程后达完全缓解（CR）或CR伴血细胞不完全恢复，6例获部分缓解，14例未缓解。有32例患者最终行造血干细胞移植。至随访截止，患者中位OS期为55.9个月。应用CLAG±DAC方案化疗后疾病缓解的患者OS期明显长于未缓解的患者（P<0.001）。多因素分析结果显示，联合DAC（OR＝4.60，95%CI 1.14～23.50, P＝0.04）、合并DNMT3A突变（OR＝0.14，95%CI 0.01～0.89, P＝0.05）是CLAG±DAC化疗方案疗效的影响因素。R/R AML合并FLT3-ITD突变患者应用CLAG+DAC方案缓解率相对更高（OR＝10.84，95%CI 1.48～288.50, P＝0.04）。 结论： CLAG±DAC方案对R/R AML患者疗效显著，且DAC联合CLAG方案更适用于合并FLT3-ITD突变的R/R AML患者。.
Keywords: Anti-tumor combination chemotherapy regimen; Decitabine; FLT3-ITD mutant; Leukemia, myeloid, acute; Refractory; Relapsed.