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International Journal of Hematology

, Volume 107, Issue 4, pp 468–477 | Cite as

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

  • Toshihiro Miyamoto
  • Koji Nagafuji
  • Tomoaki Fujisaki
  • Naoyuki Uchida
  • Kosei Matsue
  • Hideho Henzan
  • Ryosuke Ogawa
  • Ken Takase
  • Takatoshi Aoki
  • Michihiro Hidaka
  • Takanori Teshima
  • Shuichi Taniguchi
  • Koichi Akashi
  • Mine Harada
  • For the Japan Study Group for Cell Therapy and Transplantation (JSCT)
Original Article
  • 375 Downloads

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.

Keywords

AML Post-remission ASCT HiDAC 

Notes

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.).

Compliance with ethical standards

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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Copyright information

© The Japanese Society of Hematology 2017

Authors and Affiliations

  • Toshihiro Miyamoto
    • 1
  • Koji Nagafuji
    • 2
  • Tomoaki Fujisaki
    • 3
  • Naoyuki Uchida
    • 4
  • Kosei Matsue
    • 5
  • Hideho Henzan
    • 6
  • Ryosuke Ogawa
    • 7
  • Ken Takase
    • 8
  • Takatoshi Aoki
    • 9
  • Michihiro Hidaka
    • 10
  • Takanori Teshima
    • 11
  • Shuichi Taniguchi
    • 4
  • Koichi Akashi
    • 1
  • Mine Harada
    • 12
  • For the Japan Study Group for Cell Therapy and Transplantation (JSCT)
  1. 1.Department of Medicine and Biosystemic ScienceKyushu University Graduate School of Medical ScienceFukuokaJapan
  2. 2.Department of HematologyKurume University HospitalKurumeJapan
  3. 3.Department of HematologyMatsuyama Red Cross HospitalMatsuyamaJapan
  4. 4.Department of HematologyToranomon HospitalTokyoJapan
  5. 5.Department of HematologyKameda Medical CenterKamogawaJapan
  6. 6.Department of HematologyHamanomachi HospitalFukuokaJapan
  7. 7.Department of HematologyJapan Community Health Care Organization Kyushu HospitalKita-KyushuJapan
  8. 8.Department of HematologyNational Kyushu Medical CenterFukuokaJapan
  9. 9.Department of HematologyHarasanshin HospitalFukuokaJapan
  10. 10.Department of Internal Medicine, National Hospital OrganizationKumamoto Medical CenterKumamotoJapan
  11. 11.Department of HematologyHokkaido University HospitalSapporoJapan
  12. 12.Medical Center for Karatsu-Higashimatsuura Medical AssociationKaratsuJapan

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