Effect of decitabine maintenance therapy on the survival of patients with low-to-medium risk of acute myeloid leukemia and suitable for intensive therapy

doi:10.3969/j.issn.1004-583X.2025.05.010

Abstract

Abstract:

Objective To investigate the effect of maintenance therapy with decitabine on the survival of patients with low-to-medium risk of acute myeloid leukemia (AML) and suitable for intensive chemotherapy. Methods A retrospective analysis was performed on 107 patients with low-to-medium risk of AML who were suitable for intensive chemotherapy and admitted in the Second Affiliated Hospital of Anhui Medical University from January 2017 to January 2024. Patients were divided into the maintenance treatment group (n=59) and control group (n=48) according to their willingness to receive maintenance treatment with decitabine. Patients in the maintenance treatment group were subdivided into the low-risk group (n=32) and medium-risk group (n=27) according to the prognosis stratification, or subdivided into the minimal residual disease (MRD)-positive group (n=20) and MRD-negative group (n=39) according to the MRD status. Patients in the maintenance treatment group were given intravenous drips of decitabine 15 mg/m2/d for 5 days per course, with a total of 6 courses after an interval of 2 months. Regular detections were given in the control group. The clinical data were collected and compared, including the relapse-free survival (RFS) and overall survival (OS). Results As of October 2024, the median RFS was 40 months (95%CI: 11.427-68.573) in the maintenance treatment group and 19 months (95%CI: 9.085-28.915) in the control group. The median OS was 46 months (95%CI: 21.538-70.462) in the maintenance treatment group, and 32 months (95%CI: 19.318-40.682) in the control group. The differences in the median RFS and OS were statistically significant between groups (P<0.05). There were no significant differences in the median RFS and OS among AML patients receiving the maintenance treatment between the low-risk group and medium-risk group (P>0.05). The median RFS in the MRD-positive group among AML patients receiving the maintenance treatment was 23 months (95%CI: 11.712-34.288), and the median OS was 28 months (95%CI: 22.336-33.664), while the median RFS and OS in the MRD-negative group did not reach (P<0.001). The changes in cellular immune function of decitabine before and after maintenance treatment were further analyzed. It was found that the level of regulatory T cells significantly decreased, and the level of CD8⁺ T cells and natural killer cells significantly increased (P<0.05). Conclusion AML patients with a low-to-medium risk and suitable for intensive chemotherapy can yield survival benefits from decitabine maintenance therapy, which can improve the cellular immune function.

Key words: leukemia, myeloid, acute, minimal residual disease, decitabine, maintenance therapy, prognosis

CLC Number:

R733.71

Zhao Yajing, Tao Qianshan, Shen Yuanyuan, Dong Yi. Effect of decitabine maintenance therapy on the survival of patients with low-to-medium risk of acute myeloid leukemia and suitable for intensive therapy[J]. Clinical Focus, 2025, 40(5): 439-444.

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URL: http://www.lchc.cn/EN/10.3969/j.issn.1004-583X.2025.05.010

http://www.lchc.cn/EN/Y2025/V40/I5/439

Figures/Tables 9

References 22

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项目	维持治疗组(n=59)	对照组(n=48)	统计值	P值
性别[例(%)]
男女	29(49.2) 30(51.8)	24(50.0) 24(50.0)	χ²=0.087	0.931
预后分层[例(%)]
低危中危	32(54.2) 27(45.8)	22(45.8) 26(54.2)	χ²=0.861	0.389
年龄(岁)	54(14,68)	50(16,69)	Z=0.098	0.922
乳酸脱氢酶(U/L)	323(91,1 625)	291(26,1 426)	Z=0.915	0.362
原始细胞(%)	57.00(15.00,97.00)	56.99(21.50,97.00)	Z=0.030	0.976
血小板计数(×10⁹/L)	40(5,244)	35(1,228)	Z=0.704	0.483
白细胞计数(×10⁹/L)	10.86(0.57,162.00)	15.39(0.80,192.46)	Z=0.487	0.628
血红蛋白(g/L)	75.0(40.0,140.0)	80.5(23.0,141.0)	Z=0.534	0.594

项目	维持治疗组(n=59)	对照组(n=48)	统计值	P值
性别[例(%)]
男女	29(49.2) 30(51.8)	24(50.0) 24(50.0)	χ²=0.087	0.931
预后分层[例(%)]
低危中危	32(54.2) 27(45.8)	22(45.8) 26(54.2)	χ²=0.861	0.389
年龄(岁)	54(14,68)	50(16,69)	Z=0.098	0.922
乳酸脱氢酶(U/L)	323(91,1 625)	291(26,1 426)	Z=0.915	0.362
原始细胞(%)	57.00(15.00,97.00)	56.99(21.50,97.00)	Z=0.030	0.976
血小板计数(×10⁹/L)	40(5,244)	35(1,228)	Z=0.704	0.483
白细胞计数(×10⁹/L)	10.86(0.57,162.00)	15.39(0.80,192.46)	Z=0.487	0.628
血红蛋白(g/L)	75.0(40.0,140.0)	80.5(23.0,141.0)	Z=0.534	0.594

项目	MRD阴性组(n=39)	MRD阳性组(n=20)	统计值	P值
性别[例(%)]
男女	20(51.3) 19(48.7)	10(50.0) 10(50.0)	χ²=0.092	0.926
预后分层[例(%)]
低危中危	26(66.7) 13(33.3)	6(30.0) 14(70.0)	χ²=2.653	0.008
年龄(岁)	50(15,57)	52(14,68)	Z=0.098	0.922
乳酸脱氢酶(U/L)	312(91,1 625)	330(125,1 228)	Z=0.576	0.567
原始细胞(%)	54.00(15.00,96.00)	61.50(21.00,97.00)	Z=0.757	0.452
血小板计数(×10⁹/L)	42(5,244)	36.5(8,171)	Z=0.616	0.540
白细胞计数(×10⁹/L)	13.32(0.57,148.50)	10.75(1.30,162.00)	Z=1.711	0.093
血红蛋白(g/L)	77.0(40.0,133.0)	41.5(40.0,140.0)	Z=0.194	0.847

项目	MRD阴性组(n=39)	MRD阳性组(n=20)	统计值	P值
性别[例(%)]
男女	20(51.3) 19(48.7)	10(50.0) 10(50.0)	χ²=0.092	0.926
预后分层[例(%)]
低危中危	26(66.7) 13(33.3)	6(30.0) 14(70.0)	χ²=2.653	0.008
年龄(岁)	50(15,57)	52(14,68)	Z=0.098	0.922
乳酸脱氢酶(U/L)	312(91,1 625)	330(125,1 228)	Z=0.576	0.567
原始细胞(%)	54.00(15.00,96.00)	61.50(21.00,97.00)	Z=0.757	0.452
血小板计数(×10⁹/L)	42(5,244)	36.5(8,171)	Z=0.616	0.540
白细胞计数(×10⁹/L)	13.32(0.57,148.50)	10.75(1.30,162.00)	Z=1.711	0.093
血红蛋白(g/L)	77.0(40.0,133.0)	41.5(40.0,140.0)	Z=0.194	0.847

项目	维持治疗前	维持治疗后	t值	P值
调节T细胞(%)	6.471±1.692	4.748±2.585	6.023	<0.001
CD8⁺T细胞(个/μl)	395.2±186.64	570.49±457.44	3.178	0.002
NK细胞(个/μl)	126.66±85.20	210.86±172.63	4.219	<0.001