[To compare the efficacy and incidence of severe hematological adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia]
- PMID: 38049316
- PMCID: PMC10630575
- DOI: 10.3760/cma.j.issn.0253-2727.2023.09.005
[To compare the efficacy and incidence of severe hematological adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia]
Abstract
Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
目的： 比较氟马替尼与伊马替尼治疗初发慢性髓性白血病（CML）慢性期患者的治疗反应、结局以及严重血液学不良反应发生率。 方法： 回顾性收集来自国内76个中心自2006年1月至2022年11月期间确诊、年龄≥18岁、确诊后6个月内接受氟马替尼或伊马替尼作为一线治疗且临床资料相对完整的CML慢性期病例。通过倾向性评分匹配（PSM）减少一线酪氨酸激酶抑制剂（TKI）药物选择偏倚，比较两种TKI的治疗反应及结局。 结果： 研究最终纳入4 833例接受伊马替尼（4 380例）和氟马替尼（453例）作为一线治疗的成人CML慢性期患者。伊马替尼治疗组中位随访54（IQR：31~85）个月，7年完全细胞遗传学反应（CCyR）、主要分子学反应（MMR）、分子学反应4（MR(4)）和分子学反应4.5（MR(4.5)）累积获得率分别为95.2%、88.4%、78.3%和63.0%。7年无治疗失败生存（FFS）率、无进展生存（PFS）率和总生存（OS）率分别为71.8%、93.0%和96.9%。氟马替尼治疗组中位随访18（IQR：13~25）个月，2年CCyR、MMR、MR(4)和MR(4.5)累积获得率分别为95.4%、86.5%、58.4%和46.6%。2年FFS率、PFS率和OS率分别为80.1%、95.0%和99.5%。PSM分析显示，氟马替尼治疗组患者CCyR、MMR、MR(4)和MR(4.5)累积获得率及FFS率均显著高于伊马替尼治疗组患者（P值均<0.001），但两组患者PFS率（P＝0.230）和OS率（P＝0.268）差异无统计学意义。两组患者Ⅲ级及以上血液学不良反应的发生率相似（氟马替尼对伊马替尼：10.6%对8.0%）。 结论： 氟马替尼治疗初发CML慢性期患者的治疗反应获得率及FFS率均高于伊马替尼，且严重血液学不良反应发生率相似。.
Keywords: Efficacy; Flumatinib; Imatinib; Leukemia, myeloid, chronic (CML); Severe hematologic adverse events.
Conflict of interest statement
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- 中华医学会血液学分会. 慢性髓性白血病中国诊断与治疗指南(2020年版)[J] 中华血液学杂志. 2020;41(5):353–364. doi: 10.3760/cma.j.issn.0253-2727.2020.05.001. - DOI
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