International Journal of Hematology

, Volume 91, Issue 2, pp 276–283 | Cite as

Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study

  • Shigeki Ohtake
  • Shuichi Miyawaki
  • Hitoshi Kiyoi
  • Yasushi Miyazaki
  • Hirokazu Okumura
  • Shin Matsuda
  • Tadashi Nagai
  • Yuji Kishimoto
  • Masaya Okada
  • Masatomo Takahashi
  • Hiroshi Handa
  • Jin Takeuchi
  • Shinichi Kageyama
  • Norio Asou
  • Fumiharu Yagasaki
  • Yasuhiro Maeda
  • Kazunori Ohnishi
  • Tomoki Naoe
  • Ryuzo Ohno
Original Article

Abstract

A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML). Newly diagnosed patients with AML of age less than 65 were randomly assigned to receive either of the two schedules. Both groups received IDR (12 mg/m2) for 3 days and Ara-C (100 mg/m2) for 7 days. In the individualized group, if the bone marrow on day 8 did not become hypocellular with less than 15% blasts, patients received additional IDR for one more day and Ara-C for 2 or 3 more days. Patients achieving complete remission (CR) received the same post-remission therapy. The CR rate was 79.4% for the individualized group (n = 209) and 81.9% for the fixed group (n = 221) (p = 0.598). At a median follow-up of 81 months, 7-year predicted overall survival was 37% for the individualized group and 39% for the fixed group (p = 0.496), and 7-year predicted event-free survival was 22% for the individualized group and 23% for the fixed group (p = 0.546). Thus, the present study could not demonstrate any advantage of a response-oriented individualized induction therapy over a fixed-schedule induction therapy in this protocol setting.

Keywords

Acute myeloid leukemia Response-oriented individualized induction therapy Idarubicin Cytarabine 

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Copyright information

© The Japanese Society of Hematology 2010

Authors and Affiliations

  • Shigeki Ohtake
    • 1
  • Shuichi Miyawaki
    • 2
  • Hitoshi Kiyoi
    • 3
  • Yasushi Miyazaki
    • 4
  • Hirokazu Okumura
    • 1
  • Shin Matsuda
    • 5
  • Tadashi Nagai
    • 6
  • Yuji Kishimoto
    • 7
  • Masaya Okada
    • 8
  • Masatomo Takahashi
    • 9
  • Hiroshi Handa
    • 10
  • Jin Takeuchi
    • 11
  • Shinichi Kageyama
    • 12
  • Norio Asou
    • 13
  • Fumiharu Yagasaki
    • 14
  • Yasuhiro Maeda
    • 15
  • Kazunori Ohnishi
    • 16
  • Tomoki Naoe
    • 3
  • Ryuzo Ohno
    • 17
  1. 1.Department of HematologyKanazawa University Graduate School of Medical ScienceKanazawaJapan
  2. 2.Division of HematologySaiseikai Maebashi HospitalMaebashiJapan
  3. 3.Department of Hematology and OncologyNagoya University Graduate School of MedicineNagoyaJapan
  4. 4.Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease InstituteNagasaki University Graduate School of Biomedical SciencesNagasakiJapan
  5. 5.Center for Hematopoietic DisordersOhta Nishinouchi Hospital, The Ohta FoundationKohriyamaJapan
  6. 6.Division of HematologyJichi Medical UniversityShimotsukeJapan
  7. 7.The First Department of Internal MedicineKansai Medical UniversityMoriguchiJapan
  8. 8.Division of Hematology, Department of Internal MedicineHyogo College of MedicineNishinomiyaJapan
  9. 9.Division of Hematology and Oncology, Department of Internal MedicineSt. Marianna University School of MedicineKawasakiJapan
  10. 10.Department of Medicine and Clinical ScienceGunma University Graduate School of MedicineMaebashiJapan
  11. 11.Department of Hematology and RheumatologyNihon University School of MedicineTokyoJapan
  12. 12.Department of Hematology and OncologyMie University Graduate School of MedicineTsuJapan
  13. 13.Department of HematologyKumamoto University School of MedicineKumamotoJapan
  14. 14.Department of HematologySaitama Medical SchoolHidakaJapan
  15. 15.Department of HematologyKinki University School of MedicineOsaka-SayamaJapan
  16. 16.Oncology CenterHamamatsu University School of MedicineHamamatsuJapan
  17. 17.Aichi Cancer CenterNagoyaJapan

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