Objective: To analyze the treatment-free remission (TFR) outcomes in patients with chronic myeloid leukemia (CML) treated sequentially with nilotinib (NIL) after achieving deep molecular response (DMR) to imatinib (IM). Methods: Retrospectively enrolled 103 CML patients from 6 hematological centers in Henan Province who chose sequential NIL therapy or continued IM therapy after achieving DMR to first-line IM from June 2, 2013 to August 30, 2022. Among them, 42 cases were treated with sequential NIL and 61 cases continued IM therapy. The 42 patients in the sequential NIL group were further divided into 3 subgroups based on the duration of DMR at switching to sequential NIL therapy: Group 1 (17 cases): DMR duration<12 months at switching to sequential NIL therapy; Group 2 (8 cases): DMR duration≥12 months to<24 months at switching to sequential NIL therapy; Group 3 (17 cases): DMR duration≥24 months at switching to sequential NIL therapy. Follow-up ended on January 9, 2024, with a median follow-up of 40 (16, 91) months for the sequential NIL group and 49 (21, 123) months for the continuous IM group. Survival curves were plotted using the Kaplan-Meier method and the log-rank test was performed to compare the TFR rates between groups. Results: There were 19 males and 23 females with a median age [M (Q1, Q3)] of 43 (31, 50) years in the sequential NIL group. There were 32 males and 29 females with a median age of 41 (31, 50) years in the continuous IM group. Kaplan-Meier survival curve analysis showed that the TFR rate was higher in the sequential NIL group than in the continuous IM group (88.1% vs 63.9%, P=0.005). The results of subgroup analysis showed that the TFR rates in Group 1, Group 2 and Group 3 were 94.1%, 87.5% and 82.4%, respectively, with no statistically significant differences (all P>0.05).The TFR rate in Group 1 was higher than in the continued IM group (P=0.017), and there were no statistically significant differences in Group 2 and Group 3 compared with the continuous IM group(all P>0.05). Conclusion: Sequential NIL therapy after achieving DMR with IM therapy can improve the TFR rate in CML patients, especially in those with DMR duration<12 months before switching to sequential NIL therapy.
目的： 分析伊马替尼（IM）治疗获得深层分子学反应（DMR）后序贯尼洛替尼（NIL）治疗的慢性髓性白血病（CML）患者无治疗缓解结局。 方法： 回顾性纳入河南省6家血液病中心2013年6月2日至2022年8月30日接受IM一线治疗获DMR后，分别选择序贯NIL治疗或继续IM治疗的103例停药CML患者，其中序贯NIL治疗组42例，继续IM治疗组61例。42例序贯NIL治疗患者中，按序贯NIL时已获得DMR的时间不同，将患者分为3个亚组：1组（17例）：序贯NIL治疗时已获得DMR时间<12个月；2组（8例）：序贯NIL治疗时已获得DMR时间≥12个月~<24个月；3组（17例）：序贯NIL治疗时已获得DMR时间≥24个月。随访截止日期为2024年1月9日，序贯NIL治疗组中位随访时间［M（Q1，Q3）］为40（16，91）个月，继续IM治疗组中位随访时间为49（21，123）个月。采用Kaplan-Meier法绘制生存曲线，组间无治疗缓解率比较采用log-rank检验。 结果： 序贯NIL治疗组男19例，女23例，年龄［M（Q1，Q3）］为43（31，50）岁。继续IM治疗组男32例，女29例，年龄41（31，50）岁。Kaplan-Meier生存曲线分析结果显示，序贯NIL治疗组无治疗缓解率较继续IM治疗组升高（88.1%比63.9%，P=0.005）。亚组分析结果显示，1组、2组和3组患者的无治疗缓解率分别为94.1%、87.5%和82.4%，差异均无统计学意义（均P>0.05）。1组无治疗缓解率较继续IM治疗组升高（P=0.017），2组、3组无治疗缓解率与继续IM治疗组比较差异均无统计学意义（均P>0.05）。 结论： IM治疗获得DMR后序贯NIL治疗可以提高CML患者的无治疗缓解率，尤其是已获得DMR时间在12个月以内序贯NIL治疗的CML患者无治疗缓解率更高。.