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Benefit of high-dose idarubicin as induction therapy in acute myeloid leukemia: a prospective phase 2 study

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Abstract

Idarubicin 12 mg/m2 has been recommended as a standard induction therapy for acute myeloid leukemia (AML). It is unknown whether a higher dose of idarubicin can improve the remission rate. This phase 2 prospective single-arm study enrolled 45 adults with newly diagnosed AML between September 2019 and May 2021 (NCT 04,069,208). Induction therapy included administration of idarubicin 14 mg/m2 for 3 days and cytarabine 100 mg/m2 every 12 h subcutaneously for 7 days. The primary endpoint was the composite complete response rate (complete response (CR) plus complete response with incomplete blood count recovery (CRi)). The median age was 45 years (range 14–60 years). Forty (88.9%) patients had CR or CRi, including 39 patients with CR and 1 patient with CRi after one course of induction therapy. The median times to recovery of absolute neutrophil and platelet counts were 21 days. Only 1 patient died of intracranial hemorrhage during induction therapy. After a median follow-up of 14 months (range 3.5–24 months), the estimated 18-month overall survival and disease-free survival (DFS) were 66.9% and 57.5%, respectively. In conclusion, idarubicin 14 mg/m2 plus cytarabine was a safe and efficient intensive regimen for younger and fit patients with newly diagnosed AML.

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Acknowledgements

The authors thank the patients and their families.

Funding

This work was supported by the institutional research funding provided by the Non-profit Central Research Institute Fund of the Chinese Academy of Medical Sciences (Grant No. 2019-RC-HL-001 to CXX) and the Beijing Natural Science Foundation (Grant No. 7202160 to CXX).

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Authors and Affiliations

  1. Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

    Yue-ying Mao, Hua-cong Cai, Kai-ni Shen, Long Chang, Lu Zhang, Yan Zhang, Jun Feng, Wei Wang, Chen Yang, Tie-nan Zhu, Ming-hui Duan, Dao-bin Zhou, Xin-xin Cao & Jian Li

  2. State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

    Yue-ying Mao, Hua-cong Cai, Kai-ni Shen, Long Chang, Lu Zhang, Yan Zhang, Jun Feng, Wei Wang, Chen Yang, Tie-nan Zhu, Ming-hui Duan, Dao-bin Zhou, Xin-xin Cao & Jian Li

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  1. Yue-ying Mao
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  2. Hua-cong Cai
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  3. Kai-ni Shen
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  4. Long Chang
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  5. Lu Zhang
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  6. Yan Zhang
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  7. Jun Feng
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  8. Wei Wang
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  9. Chen Yang
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  10. Tie-nan Zhu
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  11. Ming-hui Duan
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  12. Dao-bin Zhou
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  13. Xin-xin Cao
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  14. Jian Li
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Contributions

Cao XX, Li J, and Zhou DB contributed to study conception and design; Mao YY contributed to patient follow-up; Mao YY and Cao XX contributed to data analysis and interpretation; Mao YY, Cai HC, Shen KN, Chang L, Zhang L, Zhang Y, Feng J, Wang W, Yang C, Zhu TN, Duan MH, Cao XX, and Li J contributed to patient enrollment; Mao YY and Cao XX wrote the paper; and all authors revised the paper and approved the submitted version.

Corresponding authors

Correspondence to Xin-xin Cao or Jian Li.

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Ethical approval

The study was approved by each site’s Institutional Ethics Committee and was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments.

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Informed consent was obtained from all patients included in the study.

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The authors declare no competing interests.

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Mao, Yy., Cai, Hc., Shen, Kn. et al. Benefit of high-dose idarubicin as induction therapy in acute myeloid leukemia: a prospective phase 2 study. Ann Hematol 101, 831–836 (2022). https://doi.org/10.1007/s00277-022-04764-4

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  • DOI: https://doi.org/10.1007/s00277-022-04764-4

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