Objective: To explore the related factors affecting the outcome of treatment free remission (TFR) in patients with chronic myeloid leukemia (CML). Methods: Clinical data of CML patients with automatic discontinuation of tyrosine kinase inhibitor (TKI) from the CML cooperative organization of Henan province between June 2, 2013 to March 27, 2021 and the follow-up time was ≥ 6 months were retrospectively analyzed. Log-rank test was used for univariate analysis and Cox proportional risk regression model was used for multivariate analysis. Results: A total of 135 patients were enrolled, and 69 patients (51.1%) were femal and 66 patients (48.9%)were male. Median age was[M(Q1,Q3)] 49 years (38, 58)at discontinuation.Before discontinuation, 72 patients (53.3%) were on treatment with second-generation TKI, 63 patients (46.7%) were on treatment with IM, 17patients (12.6%) had a history of TKI reduction/withdrawal;median duration of treatment was months 84 (68, 108) for all patients;median time of TKI treatment to DMR was months 12(8, 26);median duration of DMR was months 65 (54, 84), and 9 patients (6.7%) had unsustained DMR.The median follow-up time was months 16(6-96), 35 patients (25.9%) lost MMR at a median months 3(1-22), overall estimated TFR was 74.1%.The univariate analysis results showed that:second-generation TKI was used, the time of TKI treatment to DMR was ≤12 months, DMR duration time ≥48 months, had sustained DMR, without TKI reduction/withdrawal history were favorable factors affecting of TFR in patients with TKI discontinuation (all P<0.05).The TFR rate of the second-generation TKI therapy group was significantly higher than the IM therapy group (81.9% vs 65.1%, P=0.019).The multivariate analysis results showed that second-generation TKI treatment[RR=0.451, 95%CI (0.227-0.896), P=0.023] and had sustained DMR [RR=0.120, 95%CI (0.053-0.271), P<0.001] were the protective factors of TFR in patients with TKI discontinuation. Conclusions: Treated with second-generation TKI and had sustained DMR are the protective factors of TFR in patients with TKI discontinuation.The CML patients who had sustained DMR more≥48 months before TKI discontinuation showed a better TFR.
目的： 探讨影响慢性髓性白血病（CML）患者无治疗缓解（TFR）结局的相关因素。 方法： 回顾性分析河南省慢性粒细胞白血病联盟协作单位自2013年6月2日至2021年3月27日自动停用酪氨酸激酶抑制剂（TKI）且随访时间≥6个月的CML患者的临床资料。单因素分析采用Log-rank检验，多因素分析采用Cox比例风险回归模型法。 结果： 共纳入135例患者，其中女69例（51.1%），男66例（48.9%）；停药时中位年龄［M（Q1，Q3）］49（38，58）岁。停药前，72例（53.3%）患者应用二代TKI治疗，63例（46.7%）患者应用伊马替尼（IM）治疗，其中17例（12.6%）患者有TKI减/停病史；TKI中位累积治疗 84（68，108）个月；TKI治疗至获得深层分子学反应（DMR）的中位时间12（8，26）个月；DMR中位持续时间65（54，84）个月，其中9例（6.7%）患者DMR不稳定。中位随访16（6~96）个月，35例（25.9%）患者在中位3（1~22）个月失去主要分子学反应（MMR），总体的TFR率74.1%。单因素分析结果显示：应用二代TKI治疗、TKI治疗至获得DMR时间≤12个月、DMR持续≥48个月、DMR持续稳定、无TKI减/停病史等因素是影响停药患者TFR结局的有利因素（均P<0.05）。二代TKI治疗组患者的TFR率显著高于IM治疗组（81.9%比65.1%，P=0.019）。多因素分析结果显示：应用二代TKI治疗［RR=0.451，95%CI：0.227~0.896，P=0.023］和DMR持续稳定［RR=0.120，95%CI：0.053~0.271，P<0.001］是停药患者TFR结局的保护因素。 结论： 停药前应用二代TKI治疗和DMR持续稳定是停药患者TFR结局的保护因素。停药前获得持续稳定DMR≥48个月的CML患者，停药后获得TFR的概率更高。.