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

International Journal of Hematology volume 91, pages 276–283 (2010)Cite this 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.

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Acknowledgments

We thank all participating physicians from the 79 institutions in the JALSG for their cooperation. This study was supported in part by a grant from the Ministry of Health, Labor, and Welfare of Japan.

Author information

Affiliations

  1. Department of Hematology, Kanazawa University Graduate School of Medical Science, 13-1 Takara-machi, Kanazawa, 920-8641, Japan

    Shigeki Ohtake & Hirokazu Okumura

  2. Division of Hematology, Saiseikai Maebashi Hospital, Maebashi, Japan

    Shuichi Miyawaki

  3. Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Hitoshi Kiyoi & Tomoki Naoe

  4. Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

    Yasushi Miyazaki

  5. Center for Hematopoietic Disorders, Ohta Nishinouchi Hospital, The Ohta Foundation, Kohriyama, Japan

    Shin Matsuda

  6. Division of Hematology, Jichi Medical University, Shimotsuke, Tochigi, Japan

    Tadashi Nagai

  7. The First Department of Internal Medicine, Kansai Medical University, Moriguchi, Japan

    Yuji Kishimoto

  8. Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Masaya Okada

  9. Division of Hematology and Oncology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan

    Masatomo Takahashi

  10. Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, Maebashi, Japan

    Hiroshi Handa

  11. Department of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan

    Jin Takeuchi

  12. Department of Hematology and Oncology, Mie University Graduate School of Medicine, Tsu, Japan

    Shinichi Kageyama

  13. Department of Hematology, Kumamoto University School of Medicine, Kumamoto, Japan

    Norio Asou

  14. Department of Hematology, Saitama Medical School, Hidaka, Japan

    Fumiharu Yagasaki

  15. Department of Hematology, Kinki University School of Medicine, Osaka-Sayama, Japan

    Yasuhiro Maeda

  16. Oncology Center, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Kazunori Ohnishi

  17. Aichi Cancer Center, Nagoya, Japan

    Ryuzo Ohno

Authors
  1. Shigeki Ohtake
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  2. Shuichi Miyawaki
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  3. Hitoshi Kiyoi
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  4. Yasushi Miyazaki
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  5. Hirokazu Okumura
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  6. Shin Matsuda
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  7. Tadashi Nagai
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  8. Yuji Kishimoto
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  9. Masaya Okada
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  10. Masatomo Takahashi
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  11. Hiroshi Handa
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  12. Jin Takeuchi
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  13. Shinichi Kageyama
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  14. Norio Asou
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  15. Fumiharu Yagasaki
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  16. Yasuhiro Maeda
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  17. Kazunori Ohnishi
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  18. Tomoki Naoe
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  19. Ryuzo Ohno
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Corresponding author

Correspondence to Shigeki Ohtake.

Additional information

For the Japan Adult Leukemia Study Group (JALSG).

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Ohtake, S., Miyawaki, S., Kiyoi, H. et al. Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. Int J Hematol 91, 276–283 (2010). https://doi.org/10.1007/s12185-009-0480-5

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  • DOI: https://doi.org/10.1007/s12185-009-0480-5

Keywords

  • Acute myeloid leukemia
  • Response-oriented individualized induction therapy
  • Idarubicin
  • Cytarabine