Chen Yilin, Zhao Huifang, Guo Jingming, Zou Jing, He Wenjuan, Han Danlei, Cheng Fanjun, Zhang Yanli, Li Weiming
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Hematology, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Front Pharmacol. 2023 Jan 23;14:1101743. doi: 10.3389/fphar.2023.1101743. eCollection 2023.
In clinical studies, some patients who achieve deep molecular response (DMR) can successfully discontinue tyrosine kinase inhibitor (TKI). TKI dose reduction is also an important aspect of alleviating adverse effects and improving quality of life. This study aimed to explore the outcome after drug withdrawal in Chinese CML patients. We conducted a retrospective analysis of the outcome of 190 patients who stopped TKI. 27 patients experienced dose reduction before TKI discontinuation. The median duration of TKI treatment and MR4 before discontinuation was 82 months and 61 months. With median follow-up after stopping TKI treatment of 17 months, the estimated TFR (Treatment Free Remission) were 76.9% (95%CI, 70.2%-82.4%), 68.8% (95%CI, 61.3%-75.2%), and 65.5% (95%CI, 57.4%-72.5%) at 6, 12 and 24 months. For full-dose and low-dose TKI groups, the TFR at 24 months was 66.7% and 55.8% ( = 0.320, log-rank). Most patients (56/57) quickly achieved MMR after restarting TKI treatment. Multivariable analysis showed that patients with TKI resistance had a higher risk of molecular relapse than patients without TKI resistance ( < 0.001). TFR rates were not impaired in patients experiencing dose reduction before TKI discontinuation compared to patients with full-dose TKI. Our data on Chinese population may provide a basis for the safety and feasibility of TKI discontinuation, including discontinuation after dose reduction, in clinical practice.
在临床研究中，一些实现深度分子反应（DMR）的患者能够成功停用酪氨酸激酶抑制剂（TKI）。TKI剂量减少也是减轻不良反应和提高生活质量的一个重要方面。本研究旨在探讨中国慢性粒细胞白血病（CML）患者停药后的结局。我们对190例停用TKI的患者结局进行了回顾性分析。27例患者在停用TKI前经历了剂量减少。停药前TKI治疗和MR4的中位持续时间分别为82个月和61个月。在停止TKI治疗后中位随访17个月时，6个月、12个月和24个月时的估计无治疗缓解（TFR）率分别为76.9%（95%CI，70.2%-82.4%）、68.8%（95%CI，61.3%-75.2%）和65.5%（95%CI，57.4%-72.5%）。对于全剂量和低剂量TKI组，24个月时的TFR分别为66.7%和55.8%（P = 0.320，对数秩检验）。大多数患者（56/57）在重新开始TKI治疗后迅速达到主要分子缓解（MMR）。多变量分析显示，与无TKI耐药的患者相比，有TKI耐药的患者分子复发风险更高（P < 0.001）。与全剂量TKI患者相比，在停用TKI前经历剂量减少的患者TFR率未受影响。我们关于中国人群的数据可为临床实践中TKI停药（包括剂量减少后停药）的安全性和可行性提供依据。
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