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.

Xiao Shuai Zhang; Bing Cheng Liu; Xin DU; Yan Li Zhang; Na XU; Xiao Li Liu; Wei Ming LI; Hai Lin; Rong Liang; Chun Yan Chen; Jian Huang; Yun Fan Yang; Huan Ling Zhu; Ling Pan; Xiao Dong Wang; Gui Hui LI; Zhuo Gang Liu; Yan Qing Zhang; Zhen Fang Liu; Jian Da HU; Chun Shui Liu; Fei LI; Wei Yang; Li Meng; Yan Qiu Han; Li E Lin; Zhen Yu Zhao; Chuan Qing TU; Cai Feng Zheng; Yan Liang Bai; Ze Ping Zhou; Su Ning Chen; Hui Ying Qiu; Li Jie Yang; Xiu Li Sun; Hui Sun; Li Zhou; Ze Lin Liu; Dan Yu Wang; Jian Xin Guo; Li Ping Pang; Qing Shu Zeng; Xiao Hui Suo; Wei Hua Zhang; Yuan Jun Zheng; Qian Jiang

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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.

Author: Xiao Shuai ZHANG ¹ ; Bing Cheng LIU ² ; Xin DU ³ ; Yan Li ZHANG ⁴ ; Na XU ⁵ ; Xiao Li LIU ⁵ ; Wei Ming LI ⁶ ; Hai LIN ⁷ ; Rong LIANG ⁸ ; Chun Yan CHEN ⁹ ; Jian HUANG ¹⁰ ; Yun Fan YANG ¹¹ ; Huan Ling ZHU ¹¹ ; Ling PAN ¹¹ ; Xiao Dong WANG ¹² ; Gui Hui LI ¹³ ; Zhuo Gang LIU ¹⁴ ; Yan Qing ZHANG ¹⁵ ; Zhen Fang LIU ¹⁶ ; Jian Da HU ¹⁷ ; Chun Shui LIU ⁷ ; Fei LI ¹⁸ ; Wei YANG ¹⁴ ; Li MENG ¹⁹ ; Yan Qiu HAN ²⁰ ; Li E LIN ²¹ ; Zhen Yu ZHAO ²¹ ; Chuan Qing TU ²² ; Cai Feng ZHENG ²² ; Yan Liang BAI ²³ ; Ze Ping ZHOU ²⁴ ; Su Ning CHEN ²⁵ ; Hui Ying QIU ²⁵ ; Li Jie YANG ²⁶ ; Xiu Li SUN ²⁷ ; Hui SUN ²⁸ ; Li ZHOU ²⁹ ; Ze Lin LIU ³⁰ ; Dan Yu WANG ³⁰ ; Jian Xin GUO ³¹ ; Li Ping PANG ³² ; Qing Shu ZENG ³³ ; Xiao Hui SUO ³⁴ ; Wei Hua ZHANG ³⁵ ; Yuan Jun ZHENG ³⁵ ; Qian JIANG ¹
Author Information

1. 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 100044, China.
2. National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China.
3. The Second People's Hospital of Shenzhen, Shenzhen 518035, China.
4. Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
5. Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
6. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
7. First Hospital of Jilin University, Changchun 130021, China.
8. Xijing Hospital, Airforce Military Medical University, Xi'an 710032, China.
9. Qilu Hospital of Shandong University, Jinan 250012, China.
10. The Fourth Affiliated Hospital of Zhejiang University, Hangzhou 322000, China.
11. Institute of Hematology, West China Hospital, Sichuan University, Chengdu 610041, China.
12. Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital, Chengdu 610072, China.
13. Xi'an International Medical Center Hospital, Xi'an 710038, China.
14. Shengjing Hospital of China Medical University, Shenyang 110020, China.
15. The Second Affiliated Hospital of Harbin Medical University, Harbin 150086, China.
16. The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China.
17. Fujian Medical University Union Hospital, Fuzhou 350001, China.
18. The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.
19. Tongji Hospital of Tongji Medical College, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030, China.
20. The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010050, China.
21. Hainan General Hospital, Haikou 570311, China.
22. Shenzhen Baoan Hospital, Shenzhen University Second Affiliated Hospital, Shenzhen 518101, China.
23. Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou 450003, China.
24. The Second Hospital Affiliated to Kunming Medical University, Kunming 650106, China.
25. National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Institute of Blood and Marrow Transplantation of Soochow University, Suzhou 215006, China.
26. Xi'an International Medical Center Hospital, Xi'an 710117, China.
27. The First Affiliated Hospital of Dalian Medical University, Dalian 116011, China.
28. The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China.
29. Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
30. Huazhong University of Science and Technology Union Shenzhen Hospital, Nanshan Hospital, Shenzhen 518000, China.
31. The Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, China.
32. Peking University Shenzhen Hospital, Shenzhen 516473, China.
33. The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.
34. Handan Central Hospital, Handan 057150, China.
35. First Hospital of Shangxi Medical University, Taiyuan 300012, China.
Publication Type:Journal Article
Keywords: Efficacy; Flumatinib; Imatinib; Leukemia, myeloid, chronic (CML); Severe hematologic adverse events
MeSH: Adult; Humans; Adolescent; Imatinib Mesylate/adverse effects*; Incidence; Antineoplastic Agents/adverse effects*; Retrospective Studies; Pyrimidines/adverse effects*; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy*; Treatment Outcome; Benzamides/adverse effects*; Leukemia, Myeloid, Chronic-Phase/drug therapy*; Aminopyridines/therapeutic use*; Protein Kinase Inhibitors/therapeutic use*
From: Chinese Journal of Hematology 2023;44(9):728-736
CountryChina
Language:Chinese
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.