• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)

临床输血与检验 ›› 2023, Vol. 25 ›› Issue (4): 539-543.DOI: 10.3969/j.issn.1671-2587.2023.04.021

• 临床研究 • 上一篇    下一篇

克拉屈滨联合维奈克拉及低剂量阿糖胞苷在老年AML患者中应用的早期临床疗效及安全性分析

汪安友, 朱婷, 王丽, 蔡晓燕, 刘欣   

  1. 中国科学技术大学附属第一医院血液科,安徽合肥 230001
  • 收稿日期:2023-05-01 出版日期:2023-08-20 发布日期:2023-09-18
  • 通讯作者: 刘欣,主任医师,主要从事急性髓系白血病基础与临床研究,(E-mail)lxinahf@sina.com。
  • 作者简介:汪安友,副主任医师,博士,主要从事急性髓系白血病基础与临床研究,(E-mail)way0623@ustc.edu.cn。

Early Clinical Efficacy and Safety Analysis of Cladribine Combined with Venetoclax and Low-dose Cytarabine in Elderly AML Patients

WANG Anyou, ZHU Ting, Wang LI, et al   

  1. Department of Hematology, the First Affiliated Hospital of USTC, Hefei, Anhui 230001
  • Received:2023-05-01 Online:2023-08-20 Published:2023-09-18

摘要: 目的 小样本量分析探讨克拉屈滨联合维奈克拉及小剂量阿糖胞苷方案在老年急性髓系白血病(AML)患者中应用的早期临床疗效及安全性分析。方法 选取本中心2022年9月—2023年3月治疗的12例初治及难治性老年AML患者作为研究对象,所有患者均采用克拉屈滨联合维奈克拉+小剂量阿糖胞苷进行初次诱导化疗,化疗1~2个周期后评估临床疗效;观察分析在首次诱导化疗过程中的安全性数据,分析该方案在老年AML患者诱导治疗中的骨髓抑制情况及非血液学毒性。结果 治疗1~2个周期后,12例患者中,除2例患者1疗程后因疫情及个人原因未按期随诊复查骨髓,其余10例患者均获得临床完全缓解(CR+CRi 83.3%,10/12),在诱导化疗期间未出现死亡病例;诱导期间患者耐受性良好,平均住院27.8天,住院期间主要表现为血液学毒性,骨髓抑制情况:中性粒细胞比值低于0.5×109/L、血小板计数低于20×109/L、血红蛋白低于60 g/L的平均天数分别为12.7天、10.6天、10.8天,其中2例患者诱导化疗前合并肺部重症感染,积极稳定控制感染后给与该方案诱导化疗,化疗期间持续控制感染未加重。结论 该方案在老年AML诱导治疗中疗效较佳,较目前老年AML患者的去甲基化联合维奈克拉方案疗效有明显改善,与国外近期报道疗效基本一致,早期临床缓解率较高,且耐受性可,初次诱导化疗期间无死亡病例,所有患者血液学及非血液学毒性可控,值得临床进一步推广应用。

关键词: 克拉屈滨, 维奈克拉, 老年, 急性髓系白血病

Abstract: Objective This study aimed to explore the early clinical efficacy and safety of cladribine combined with venetoclax and low-dose cytarabine in elderly patients with acute myeloid leukemia (AML) by small sample analysis. Methods From September 2022 to March 2023, 12 newly diagnosed and refractory elderly AML patients in our center were selected as the study subjects. All patients were treated with cladribine combined with venetoclax+low-dose cytarabine for the first induction chemotherapy. The clinical efficacy was evaluated after 1~2 cycles of chemotherapy; the safety data was collected and analyzed during the first induction chemotherapy process, and the bone marrow suppression and non hematological toxicity of this protocol were evaluated in elderly AML patients undergoing induction therapy. Results After 1~2 cycles of treatment, 12 patients achieved complete clinical remission (CR+CRi 83.3%,10/12), except for 2 patients who did not follow up with bone marrow due to the epidemic and personal reasons after the first course of treatment. No deaths occurred during the induction chemotherapy period; During that period, the patient had good tolerance and was hospitalized for an average of 27.8 days. During the hospitalization period, the main manifestations were hematological toxicity and bone marrow suppression. The average days of neutrophil ratio below 0.5×109/L, platelet count below 20×109/L, and hemoglobin below 60 g/L were 12.7 days, 10.6 days, and 10.8 days, respectively. Among them, 2 patients had severe pulmonary infections before induction chemotherapy, and after actively and stably controlling the infection, this regimen was administered for induction chemotherapy, During chemotherapy, the infection did not worsen on the basis of continuous treatment. Conclusion This protocol has a better therapeutic effect in the induction therapy of elderly AML, and has a significant improvement compared to the current demethylation combined with Vineclavone protocol in elderly AML patients. The efficacy is basically consistent with recent reports abroad, with a high early clinical remission rate and tolerability. There are no deaths during the initial induction chemotherapy period, and all patients have controllable hematological and non hematological toxicity, which is worthy of further clinical promotion and application.

Key words: Cladribine, Venetoclax, Elderly, Acute myeloid leukemia

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