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地西他滨联合小剂量阿糖胞苷治疗老年复发/难治性急性髓系白血病的疗效、预后及安全性

[Efficacy, Prognosis and Safety of Decitabine Combined with Low-Dose Cytarabine in the Treatment of Elderly Patients with Relapsed/Refractory Acute Myeloid Leukemia].

作者信息

Chen Dong, Lu Ying, Yan Ren-Zh, Ye Pei-Pei, Zhang Yu-Sheng, Ma Jun-Xia

机构信息

Department of Hematology, Yinzhou Hospital Affiliated to Ningbo University, Ningbo 315105, Zhejiang Province, China,E-mail:

Department of Hematology, Yinzhou Hospital Affiliated to Ningbo University, Ningbo 315105, Zhejiang Province, China.

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Apr;27(2):390-395. doi: 10.19746/j.cnki.issn.1009-2137.2019.02.013.

DOI:10.19746/j.cnki.issn.1009-2137.2019.02.013
PMID:30998143
Abstract

OBJECTIVE

To investigate the efficacy, prognosis and safety of decitabine combined with low-dose CAG regimen in the treatment of elderly patients with acute myeloid leukemia (AML).

METHODS

The clinical data of 40 elderly patients with relapsed/refractory AML (69-85 years old) admitted to our hospital from January 2014 to August 2016 were analyzed retrospectively. 40 patients were divided into combination therapy group and CAG group according to different treatment methods. 20 patients of the combination therepy group were treated with decitabine combined with low-dose CAG (decitabine, 15 mg/m, d 1; aclarithromycin, 10 mg/m, d 3-6; Cytidine, 10 mg/m, d 1-14; recombinant human granulocyte macrophage colony-stimulating factor (G-CSF) for injection, 200 μg/(m·d), d 1-14). 20 patients of CAG group were treated by the standard CAG protocol (acralmycin 20 mg/m, d 1-4; cytarabine for injection, 15 mg/m, d 1-14; G-CSF 400 μg/(m·d), d 1-14). One course of treatment lasted for 2 weeks, after 2 courses of continuous medication, the complete remission rate (CR), overall remission rate (ORR), overall survival (OS), 1-year survival rate, hemoglobin, white blood cells, platelets improvement, and incidence of adverse reactions were compared.

RESULTS

In combination therapy group the CR was 55.00% (11/20), OR was 85.00% (17/20), but in the CAG group CR was 30.00% (6/20), and OR was 50.00% (10/20). Till to February 2018, out of 40 patients 17 survived, 20 died, and 3 failed to be followed-up. The median follow-up time was 12 (2 to 35) months; the median survival time in the comtination therapy group was 13 (2-35) months, and the 1-year OS rate was 70.00%, and the median survival time of the CAG group was 10 (2-31) months, and the 1-year OS rate was 50.00%, without staistical significance between the 2 groups (P>0.05). After treatment, the WBC and Plt counts in the combination therapy group were higher than those in the CAG group, but the Hb level was lower than that in the CAG group with statistically significant difference (P<0.05). In the combination therapy group, the incidence of lung infection, nausea and vomiting was higher than that of the CAG group (65.00% vs 25.00%, 50.00% vs 20.00%), with statistically significant difference (P<0.05).

CONCLUSION

Decitabine combined with low-dose CAG regimen is effective for the treatment of relapsed/refractory AML in the elderly. Compared with the standard CAG regimen, the long-term efficacy of this regimen is not different significantly, but its adverse reactions are increase, thus the preventive treatment should be given in time.

摘要

目的

探讨地西他滨联合小剂量CAG方案治疗老年急性髓系白血病(AML)的疗效、预后及安全性。

方法

回顾性分析2014年1月至2016年8月我院收治的40例复发/难治性老年AML患者(69 - 85岁)的临床资料。根据治疗方法将40例患者分为联合治疗组和CAG组。联合治疗组20例患者采用地西他滨联合小剂量CAG方案治疗(地西他滨,15mg/m²,d1;阿克拉霉素,10mg/m²,d3 - 6;阿糖胞苷,10mg/m²,d1 - 14;注射用重组人粒细胞巨噬细胞集落刺激因子(G - CSF),200μg/(m²·d),d1 - 14)。CAG组20例患者采用标准CAG方案治疗(阿克拉霉素20mg/m²,d1 - 4;注射用阿糖胞苷,15mg/m²,d1 - 14;G - CSF 400μg/(m²·d),d1 - 14)。1个疗程治疗持续2周,连续用药2个疗程后,比较两组的完全缓解率(CR)、总缓解率(ORR)、总生存期(OS)、1年生存率、血红蛋白、白细胞、血小板改善情况及不良反应发生率。

结果

联合治疗组CR为55.00%(11/20),OR为85.00%(17/20),而CAG组CR为30.00%(6/20),OR为�0.00%(10/20)。至2018年2月,40例患者中17例存活,20例死亡,3例失访。中位随访时间为12(2至35)个月;联合治疗组中位生存时间为13(2 - 35)个月,1年OS率为70.00%,CAG组中位生存时间为10(2 - 31)个月,1年OS率为50.00%,两组比较差异无统计学意义(P>0.05)。治疗后,联合治疗组白细胞和血小板计数高于CAG组,但血红蛋白水平低于CAG组,差异有统计学意义(P<0.05)。联合治疗组肺部感染、恶心呕吐发生率高于CAG组(65.00% vs 25.00%,50.00% vs 20.00%),差异有统计学意义(P<0.05)。

结论

地西他滨联合小剂量CAG方案治疗老年复发/难治性AML有效。与标准CAG方案相比,该方案长期疗效无明显差异,但不良反应增加,应及时给予预防性治疗。

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