Real-world effectiveness of mitoxantrone hydrochloride liposome containing regimens in acute myeloid leukemia

  • Oncologist. 2025 Oct 1;30(10):oyaf304. doi: 10.1093/oncolo/oyaf304.
Tie-Jun Gong  1 ,  Wei-Ming Li  2 ,  Li Liu  3 ,  Yu-Qing Chen  4 ,  Su-Jun Gao  5 ,  Wei Yang  6 ,  Xiao-Yu Zhu  7 ,  Jian-Chuan Deng  8 ,  Yan Liu  9 ,  Jing-Yu Zhang  10 ,  Xiao-Yan Ge  11 ,  Hui Li  12 ,  Xiao-Gang Wang  13 ,  Yuan-Song Bai  14 ,  Xiao-Hong Tan  15 ,  Yi-Cheng Zhang  16 ,  Peng-Cheng He  17 ,  Jun-Jie Ma  18 ,  Yan-Li Yang  19 ,  Yu-Hu Feng  20 ,  Xu-Dong Wei  21 ,  Jian-Yong Li  22 ,  Lei Fan  22 ,  Hong-Zhi Xu  23 ,  Hong-Xiang Wang  24 ,  Xiao-Jing Yan  25 ,  Ze-Ping Zhou  26 ,  Hua Zhong  27 ,  Ying Zhang  28 ,  Jun Ma  1
Affiliations
  • 1. Harbin Institute of Hematology & Oncology, Harbin the First Hospital, Harbin, 150010, China.
  • 2. Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
  • 3. Department of Hematology, Tangdu Hospital, Xi 'an, 710038, China.
  • 4. Department of Hematology, Henan Provincial People's Hospital, Zhengzhou, 450003, China.
  • 5. Department of Hematology, The First Bethune Hospital of Jilin University, Changchun, 130021, China.
  • 6. Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, 110004, China.
  • 7. Department of Hematology, Anhui Provincial Hospital, Hefei, 230001, China.
  • 8. Department of Hematology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400010, China.
  • 9. Department of Hematology, Zibo Central Hospital, Zibo, 250036, China.
  • 10. Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.
  • 11. Department of Hematology, Second Hospital of Shanxi Medical University, Taiyuan, 030001, China.
  • 12. Department of Hematology, Sichuan Provincial People's Hospital, Chengdu, 610072, China.
  • 13. Department of Hematology, Zhejiang Provincial People's Hospital, Hangzhou, 310014, China.
  • 14. Department of Oncology, The Third Bethune Hospital of Jilin University, Changchun, 130033, China.
  • 15. Department of Lymphatic Hematology and Pediatric Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530200, China.
  • 16. Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
  • 17. Department of Hematology, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, 710061, China.
  • 18. Department of Hematology, Yantai Yuhuangding Hospital, Yantai, 264000, China.
  • 19. Department of Hematology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 233004, China.
  • 20. Department of Hematology, Fuyang People's Hospital, Fuyang, 236001, China.
  • 21. Department of Hematology, Henan Cancer Hospital, Zhengzhou, 450003, China.
  • 22. Department of Hematology, Jiangsu Province Hospital, Nanjing, 210029, China.
  • 23. Department of Hematology, Shandong Provincial Hospital, Jinan, 250021, China.
  • 24. Department of Hematology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430014, China.
  • 25. Department of Hematology, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China.
  • 26. Department of Hematology, The Second Affiliated Hospital of Kunming Medical University, Kunming, 650101, China.
  • 27. Department of Hematology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.
  • 28. Department of Hematology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.
PMID: 41081610 DOI: 10.1093/oncolo/oyaf304
Abstract

Background: Mitoxantrone hydrochloride Liposome (Lipo-MIT) exhibits encouraging efficacy in treating multiple hematologic malignancies. This study evaluated the real-world efficacy and safety of Lipo-MIT-containing regimens in the treatment of acute myeloid leukemia (AML).

Methods: This noninterventional, ambispective cohort study was conducted at 42 centers in China. Patients with newly diagnosed or relapsed/refractory AML who received Lipo-MIT-containing regimens were included. The primary endpoint was the composite complete remission (CRc) rate.

Results: Between January 2022 and December 2023, 117 patients with newly diagnosed AML and 122 patients with relapsed/refractory AML were included. The CRc and objective response rates were 84.6% (95% confidence interval [CI], 76.8-90.6) and 91.5% (95% CI, 84.8-95.8), respectively, in the newly diagnosed AML, and 45.1% (95% CI, 36.1-54.3) and 55.7% (95% CI, 46.5-64.7), respectively, in relapsed/refractory AML. The 2-year-event-free survival and overall survival rates for newly diagnosed AML were 67.0% (95% CI, 54.4-76.8) and 77.8% (95% CI, 63.8-86.9), respectively, while the rates for relapsed/refractory AML were 23.9% (95% CI, 12.5-37.3) and 56.9% (95% CI, 39.6-70.9), respectively. Univariate and multivariate analyses suggested age and the number of prior failed induction therapy cycles as independent prognostic factors for CRc in relapsed/refractory AML (all P < .05). Treatment-related adverse events (AEs) were reported in 216 patients (90.4%). Thrombocytopenia (64.4%), leukopenia (63.6%), and neutropenia (60.7%) were the most common AEs of grade 3-4. No treatment-related deaths occurred.

Conclusions: Lipo-MIT-containing regimens were effective and well-tolerated in AML under real-world circumstances.

Trial registration id: ChiCTR2200067172.

Keywords
acute myeloid leukemia; composite complete remission; mitoxantrone hydrochloride liposome; newly diagnosed acute myeloid leukemia; relapsed/refractory acute myeloid leukemia.
Products