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    阿扎胞苷联合维奈克拉治疗不适合强化疗的初诊急性髓系白血病患者的临床观察

    Clinical observation of azacitidine combined with venetoclax in patients initially diagnosed with acute myeloid leukemia not suitable for intense chemotherapy

      摘要
    • 摘要: 目的 探讨阿扎胞苷联合维奈克拉治疗不适合强化疗的初诊急性髓系白血病（AML）患者的疗效及安全性。方法 选取2020年2月—2023年6月徐州医科大学附属医院血液科收治的35例不适合强化疗的初诊AML患者，收集其临床资料进行回顾性分析。所有患者均采用阿扎胞苷联合维奈克拉方案：阿扎胞苷75 mg/m2 d1~d7皮下注射，标准剂量为维奈克拉100 mg d1、200 mg d2、400 mg d3~d28，小剂量缩短为维奈克拉400 mg d3~d14口服。比较患者疗效、生存情况及不良反应。结果 诱导1个疗程后，35例患者的缓解率为57.2%（20例），11例患者获得血细胞计数未完全恢复的完全缓解（CRi），9例患者获得完全缓解（CR），其中14例获得根据微小残留病（MRD）评估分子生物学的完全缓解（CRm）。年龄<60岁患者10例，CR/CRi率为50%。23例标准剂量患者CR/CRi率为52.2%（12例），12例小剂量患者CR/CRi率为66.7%（8例），2组比较差异无统计学意义（P>0.05）。所有患者中位疗程数为2（1~8）个，其中25例患者治疗1~2个疗程，中位总生存期（OS）为12.3（0.4~14）个月，10例患者治疗≥3个疗程，中位OS为12.6（4~27.2）个月，2组比较差异有统计学意义（P=0.002）。患者不良反应主要为血液学毒性，其次为消化系统反应，但大多数患者均可耐受。结论 阿扎胞苷联合维奈克拉治疗不适合强化疗的初诊AML患者的疗效肯定，患者耐受性良好。

       

      Abstract: Objective To investigate the effectiveness and safety of azacitidine combined with venetoclax in the treatment of patients initially diagnosed with acute myeloid leukemia (AML) not suitable for intense chemotherapy.Methods A total of 35 patients initially diagnosed with AML who were admitted to Department of Hematology, the Affiliated Hospital of Xuzhou Medical University from February 2020 to June 2023, but not suitable for intensive chemotherapy were selected and their clinical data were retrospectively analyzed. All the patients were treated with azacitidine combined with venetoclax in the following regimen. Azacitidine was subcutaneously injected at 75 mg/m2 on days 1-7, while the standard dose of venetoclax was 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-28, and the low dose of venetoclax was reduced to 400 mg on days 3-14. Then, their clinical effectiveness, survival and adverse reactions were analyzed.Results After one course of induction, the remission rate was 57.2% (20/35), where 9 patients obtained complete response (CR), 11 patients obtained complete remission with incomplete blood count recovery (Cri), and 14 patients obtained complete remission based on measurable residual disease (CRm). There were 10 patients less than 60 years old, with a CR/CRi ratio of 50%. The CR/CRi ratio of 23 patients with standard dose was 52.2% (12 cases), and that of 12 patients with small dose was 66.7% (8 cases), without statistical difference between the two groups (P>0.05). The median number of courses of treatment for all the patients was 2 (1-8), where 25 patients were treated for 1-2 courses, with a median overall survival (OS) of 12.3 (0.4-14) months, and 10 patients were treated for ≥ 3 courses, with a median OS of 12.6 (4-27.2) months, and there was statistical difference between the two groups (P=0.002). The main adverse reactions were hematological toxicity, followed by digestive system reactions, but most of which were tolerable.Conclusions Azacitidine combined with venetoclax is effective and well tolerated in the treatment of patients newly diagnosed with AML not suitable for intensive chemotherapy.

       

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