Zhao H F, Zhang Yanli, Dang L X, Liang J L, Chen S X, Guo Z, Li Y L, Zu R R, Gui X D, Wei Y P, Song Yongping
Department of Hematology, Henan Cancer Hospital, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
Department of Hematology, the first Affiliated Hospital of Nanyang Medical College, Nanyang 473000, China.
Zhonghua Yi Xue Za Zhi. 2022 May 31;102(20):1523-1529. doi: 10.3760/cma.j.cn112137-20220112-00074.
To explore the related factors affecting the outcome of treatment free remission (TFR) in patients with chronic myeloid leukemia (CML). 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. A total of 135 patients were enrolled, and 69 patients (51.1%) were femal and 66 patients (48.9%)were male. Median age was[(,)] 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 <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%, =0.019).The multivariate analysis results showed that second-generation TKI treatment[=0.451, (0.227-0.896), =0.023] and had sustained DMR [=0.120, (0.053-0.271), <0.001] were the protective factors of TFR in patients with TKI discontinuation. 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.
探讨影响慢性髓性白血病（CML）患者停止治疗后缓解（TFR）结局的相关因素。回顾性分析2013年6月2日至2021年3月27日河南省CML协作组中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。采用Log-rank检验进行单因素分析，Cox比例风险回归模型进行多因素分析。共纳入135例患者，其中女性69例（51.1%），男性66例（48.9%）。停药时中位年龄为49岁（38，58）。停药前，72例（53.3%）患者接受第二代TKI治疗，63例（46.7%）患者接受伊马替尼（IM）治疗，17例（12.6%）患者有TKI减量/停药史；所有患者治疗中位持续时间为84个月（68，108）；TKI治疗至主要分子学缓解（DMR）的中位时间为12个月（8，26）；DMR中位持续时间为65个月（54，84），9例（6.7%）患者DMR未持续。中位随访时间为16个月（6 - 96），35例（25.9%）患者在中位3个月（1 - 22）时失去主要分子学缓解（MMR），总体估计TFR为74.1%。单因素分析结果显示：使用第二代TKI、TKI治疗至DMR的时间≤12个月、DMR持续时间≥48个月、有持续DMR、无TKI减量/停药史是影响TKI停药患者TFR的有利因素（均P<0.05）。第二代TKI治疗组的TFR率显著高于IM治疗组（81.9% vs 65.1%，P = 0.019））。多因素分析结果显示第二代TKI治疗（P = 0.451，95%CI（0.227 - 0.896），P = 0.023）和有持续DMR（P = 0.120，95%CI（0.053 - 0.271），P<0.001）是TKI停药患者TFR的保护因素。接受第二代TKI治疗且有持续DMR是TKI停药患者TFR的保护因素。在TKI停药前DMR持续≥48个月的CML患者显示出更好的TFR。
