Jun Kong, Ya-Zhen Qin, Xiao-Su Zhao, Hong-Xia Shi, Yue-Yun Lai, Kai-Yan Liu, Xiao-Jun Huang, Hao Jiang
Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China.
Peking University People's Hospital, Institute of Hematology, National Clinical Research Center for Hematologic Disease, No. 11, Xizhimen South Street, Xicheng District, Beijing, 100044, People's Republic of China.
Ther Adv Hematol. 2021 Jan 22;12:2040620720986643. doi: 10.1177/2040620720986643. eCollection 2021.
Currently, the goal of chronic myeloid leukemia (CML) treatment is normal survival and good quality of life without life-long treatment, namely, "treatment-free remission" (TFR). At present, approximately only 50% of patients with CML with a deep molecular response are able to discontinue tyrosine kinase inhibitor (TKI) without experiencing molecular relapse [MR; loss of major molecular response (MMR)]. In addition, prior interferon (IFN) treatment is associated with a higher rate of TFR.
We aimed to evaluate the feasibility of TKI discontinuation in Chinese patients with CML and determine whether IFN could prevent MR when used after TKI discontinuation in patients with 0.0032% < ⩽0.1%. Therefore, we retrospectively analyzed the data of patients with CML who discontinued TKI treatment at our center.
Forty-nine patients who discontinued TKI therapy after achieving MR 4.5 were included in this study, and the median follow-up time from TKI discontinuation was 27 (7, 75) months. Nineteen patients eventually lost MMR, and the TFR rate of the 49 patients was 67% (95% confidence interval 53.6%, 80.3%) at 12 months. The duration of MR 4.5 ⩾54 months and duration of imatinib ⩾85 months were significantly associated with a higher TFR rate. Of the 22 patients with 0.0032% < ⩽0.1%, 12 received IFN-α treatment. The median IFN-α therapy duration was nine (2, 18) months, and three patients eventually lost MMR. Three patients discontinued IFN-α after 2, 2.5, and 10 months, and maintained MMR for 9, 8, and 11 months after IFN discontinuation, respectively. Of the 10 patients not receiving IFN-α treatment, eight eventually lost MMR. The MR-free survival rate was significantly different between the patients treated with and those treated without IFN-α over 24 months (70.7% 15.0%, = 0.002).
These results indicate that after TKI discontinuation, IFN-α can be administered to patients with 0.0032% < ⩽0.1%, which may help prevent MR.
目前,慢性髓性白血病(CML)治疗的目标是实现正常生存且生活质量良好,无需终身治疗,即“无治疗缓解”(TFR)。目前,在达到深度分子反应的CML患者中,约仅有50%能够停用酪氨酸激酶抑制剂(TKI)而不发生分子复发[MR;主要分子反应(MMR)丧失]。此外,既往接受干扰素(IFN)治疗与更高的TFR发生率相关。
我们旨在评估中国CML患者停用TKI的可行性,并确定在TKI停用后对0.0032%<≤0.1%的患者使用IFN是否能预防MR。因此,我们回顾性分析了在本中心停用TKI治疗的CML患者的数据。
本研究纳入了49例在达到MR 4.5后停用TKI治疗的患者,从停用TKI起的中位随访时间为27(7,75)个月。19例患者最终丧失MMR,49例患者在12个月时的TFR率为67%(95%置信区间53.6%,80.3%)。MR 4.5持续时间≥54个月以及伊马替尼治疗持续时间≥85个月与更高的TFR率显著相关。在22例0.0032%<≤0.1%的患者中,12例接受了IFN-α治疗。IFN-α治疗的中位持续时间为9(2,18)个月,3例患者最终丧失MMR。3例患者分别在2、2.5和10个月后停用IFN-α,并在停用IFN后分别维持MMR达9、8和11个月。在10例未接受IFN-α治疗的患者中,8例最终丧失MMR。在24个月期间,接受IFN-α治疗和未接受IFN-α治疗的患者的无MR生存率存在显著差异(70.7%对15.0%,P = 0.002)。
这些结果表明,在停用TKI后,可对0.0032%<≤0.1%的患者给予IFN-α,这可能有助于预防MR。