2. Academic Validation
  3. Real-world effectiveness of mitoxantrone hydrochloride liposome containing regimens in acute myeloid leukemia

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

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.

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