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Prospective randomization of post-remission therapy comparing autologous peripheral blood stem cell transplantation versus high-dose cytarabine consolidation for acute myelogenous leukemia in first remission

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Abstract

We prospectively compared outcomes of autologous stem cell transplantation (ASCT) versus high-dose cytarabine (HiDAC) consolidation as post-remission therapy for favorable- and intermediate-risk acute myelogenous leukemia (AML) in first complete remission (CR1). Two-hundred-forty patients under 65 years with AML-M1, M2, M4, or M5 subtypes were enrolled. After induction, 153 patients did not undergo randomization, while the remaining 87 who achieved CR1 were prospectively randomized to HiDAC (n = 45) or ASCT arm (n = 42). In the HiDAC arm, 43 patients completed three cycles of HiDAC, whereas in ASCT arm 22 patients completed two cycles of consolidation consisting of intermediate-dose cytarabine plus mitoxantrone or etoposide followed by ASCT. The three-year disease-free survival (DFS) rate was 41% in HiDAC and 55% in ASCT arm (p = 0.25). Three-year overall survival (OS) rates were 77 and 68% (p = 0.67). Incidence of relapse was 54 and 41% (p = 0.22). There was no significant difference in nonrelapse mortality between two arms (p = 0.88). Patients in the ASCT arm tended to have higher DFS rates and lower relapse rates than patients in HiDAC; however, there was no significant improvement in OS in patients with favorable- and intermediate-risk AML in CR1. Patients with AML are not benefited by the intensified chemotherapy represented by ASCT.

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Acknowledgements

We thank the medical and nursing staff working on the JSCT for providing patient information. This work was supported by a Grant from the Regional Medicine Research Foundation (Tochigi, Japan). This work was also supported by a Grant-in-Aid for Scientific Research (no. 16H05340 to T.M.) and Grant-in-Aid for Scientific Research on Innovative Areas “Stem Cell Aging and Disease” (no. 25115002 to T.M.).

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Authors and Affiliations

  1. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan

    Toshihiro Miyamoto & Koichi Akashi

  2. Department of Hematology, Kurume University Hospital, Kurume, Japan

    Koji Nagafuji

  3. Department of Hematology, Matsuyama Red Cross Hospital, Matsuyama, Japan

    Tomoaki Fujisaki

  4. Department of Hematology, Toranomon Hospital, Tokyo, Japan

    Naoyuki Uchida & Shuichi Taniguchi

  5. Department of Hematology, Kameda Medical Center, Kamogawa, Japan

    Kosei Matsue

  6. Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan

    Hideho Henzan

  7. Department of Hematology, Japan Community Health Care Organization Kyushu Hospital, Kita-Kyushu, Japan

    Ryosuke Ogawa

  8. Department of Hematology, National Kyushu Medical Center, Fukuoka, Japan

    Ken Takase

  9. Department of Hematology, Harasanshin Hospital, Fukuoka, Japan

    Takatoshi Aoki

  10. Department of Internal Medicine, National Hospital Organization, Kumamoto Medical Center, Kumamoto, Japan

    Michihiro Hidaka

  11. Department of Hematology, Hokkaido University Hospital, Sapporo, Japan

    Takanori Teshima

  12. Medical Center for Karatsu-Higashimatsuura Medical Association, Karatsu, Japan

    Mine Harada

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  1. Toshihiro Miyamoto
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  2. Koji Nagafuji
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  8. Ken Takase
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  9. Takatoshi Aoki
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  13. Koichi Akashi
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  14. Mine Harada
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For the Japan Study Group for Cell Therapy and Transplantation (JSCT)

Corresponding author

Correspondence to Toshihiro Miyamoto.

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Conflict of interest

The authors declare that they have no conflict of interest. T.M., K.N., and M.H. designed this study, collected clinical information, and wrote the manuscript. S.T, K.T, G.Y, S.Y, H.H, K.K, K.O, T.A., H.I, H.H, T.T, and K.A contributed to the collection of clinical information. All authors read and approved the final manuscript.

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Miyamoto, T., Nagafuji, K., Fujisaki, T. et al. Prospective randomization of post-remission therapy comparing autologous peripheral blood stem cell transplantation versus high-dose cytarabine consolidation for acute myelogenous leukemia in first remission. Int J Hematol 107, 468–477 (2018). https://doi.org/10.1007/s12185-017-2389-8

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  • DOI: https://doi.org/10.1007/s12185-017-2389-8

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