引用本文:金珂熠,章 澜,王圣洁,陈 丹,郑 艳,朱晓琼,黄 健.慢性髓性白血病慢性期患者酪氨酸激酶抑制剂治疗停药后的临床特征及转归分析[J].中国临床新医学,2022,15(9):822-826.
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慢性髓性白血病慢性期患者酪氨酸激酶抑制剂治疗停药后的临床特征及转归分析
金珂熠,章 澜,王圣洁,陈 丹,郑 艳,朱晓琼,黄 健
322000 义乌,浙江大学医学院附属第四医院血液内科(金珂熠,章 澜,王圣洁,陈 丹,郑 艳,朱晓琼,黄 健);310003 杭州,浙江大学医学院附属第一医院血液科(黄 健);310003 杭州,浙江省血液病临床医学研究中心(金珂熠,章 澜,王圣洁,陈 丹,郑 艳,朱晓琼,黄 健)
摘要:
[摘要] 目的 分析慢性髓性白血病慢性期(CML-CP)患者酪氨酸激酶抑制剂(TKI)治疗停药后的临床特征及转归。方法 回顾性分析2015年3月至2021年8月在浙江大学医学院附属第四医院血液内科治疗的8例CML-CP患者的临床资料,均达停药标准后停药并规律随访。男性4例,女性4例;年龄31~69岁,中位年龄49岁。接受一线一代TKI(原研药)治疗3例,一线一代TKI(仿制药)治疗4例,一线二代TKI(尼洛替尼)治疗1例。观察其停药后无治疗缓解(TFR)情况及复发情况。结果 8例患者从TKI用药至达到MR4.0的时长为2~64个月,中位时长为19.5个月;维持MR4.0及以上的时长为24~144个月,中位时长为60个月;总体TKI治疗时长为48~146个月,中位时长为95个月。均符合相关指南标准后停药。截至2021年8月,8例患者的停药时长为2~64个月,中位停药时长为11.5个月。4例患者未复发,总体TFR率为50.00%。未复发病例中,1例使用一线二代TKI,2例使用一线一代TKI(原研药),1例使用一线一代TKI(仿制药)。复发患者中,2例在6个月内复发,2例停药时长>6个月。复发后再次服药,患者均达到MR4.0,其中3例再服一代TKI(仿制药)后3个月内转阴,1例更换为二代TKI后15个月转阴。结论 本组CML-CP患者停药后的总TFR率为50.00%,使用一线二代TKI及一线一代TKI(原研药)的患者的TFR率更优。
关键词:  慢性髓性白血病  酪氨酸激酶抑制剂  无治疗缓解  复发
DOI:10.3969/j.issn.1674-3806.2022.09.09
分类号:R 733.7
基金项目:浙江省科技“领雁”研发攻关计划项目(编号:2022C03137);浙江省基础公益研究项目(编号:LGF21H080003);金华市科技公益重点项目(编号:2020-3-011);金华市一类医学重点学科建设项目(编号:20192033)
Analysis on the clinical characteristics and outcomes of patients with chronic myeloid leukemia in chronic phase after discontinuation of tyrosine kinase inhibitor therapy
JIN Ke-yi, ZHANG Lan, WANG Sheng-jie, et al.
Department of Hematology, the Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu 322000, China; Zhejiang Clinical Medical Research Center of Hematology, Hangzhou 310003, China
Abstract:
[Abstract] Objective To analyze the clinical characteristics and outcomes of patients with chronic myeloid leukemia in chronic phase(CML-CP) after discontinuation of tyrosine kinase inhibitor(TKI) therapy. Methods The clinical data of 8 CML-CP patients treated in Department of Hematology, the Fourth Affiliated Hospital of Zhejiang University School of Medicine, from March 2015 to August 2021 were retrospectively analyzed. All the patients were discontinued after reaching the criteria for drug discontinuation and were followed up regularly. The patients included 4 males and 4 females, and their age ranged from 31 to 69 years, with a median age of 49 years. Three cases received first-line first-generation TKI(original drug) treatment, and 4 cases received first-line first-generation TKI(generic drug) treatment, and 1 case received first-line second-generation TKI(nilotinib) treatment. The treatment-free remission(TFR) and recurrence were observed after drug discontinuation. Results The duration from TKI treatment to reaching MR4.0 was 2-64 months in the 8 patients, with a median duration of 19.5 months. The duration of maintaining MR4.0 and above was 24-144 months, with a median duration of 60 months. The overall duration of TKI treatment was 48 to 146 months, with a median duration of 95 months. All the 8 patients were discontinued after meeting the criteria of relevant guidelines. By August 2021, the duration of drug discontinuation in the 8 patients ranged from 2 to 64 months, with a median duration of 11.5 months. Four patients had no recurrence, and the overall TFR rate was 50.00%. Among the non-recurrent cases, 1 case received first-line second-generation TKI treatment, and 2 cases received first-line first-generation TKI(original drug), and 1 case received first-line first-generation TKI(generic drug). Among the recurrent patients, 2 patients had recurrence within 6 months, and 2 patients were discontinued for more than 6 months. After recurrence, all the recurrent patients took medication again and achieved MR4.0. Among them, 3 patients turned negative within 3 months after taking the first-generation TKI(generic drug), and 1 patient turned negative within 15 months after switching to the second-generation TKI treatment. Conclusion In this study, the total TFR rate of CML-CP patients after drug discontinuation is 50.00%, and the TFR rates of patients receiving first-line second-generation TKI and first-line first-generation TKI(original drug) are better.
Key words:  Chronic myeloid leukemia(CML)  Tyrosine kinase inhibitor(TKI)  Treatment-free remission(TFR)  Recurrence