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Randomized comparison of fixed-schedule versus response-oriented individualized induction therapy and use of ubenimex during and after consolidation therapy for elderly patients with acute myeloid leukemia: the JALSG GML200 Study

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Abstract

We conducted a multicenter prospective randomized study to compare a fixed-scheduled induction therapy with a response-oriented individualized induction therapy for elderly patients with acute myeloid leukemia (AML). Newly diagnosed AML patients, aged between 65 and 80, were randomly assigned to receive fixed or individualized induction. Both groups received daunorubicin (DNR) 40 mg/m2 for 3 days and behenoyl cytarabine (BHAC) 200 mg/m2 for 8 days. In the individualized group, bone marrow biopsy was done on days 8 and 10, and according to the cellularity and blast ratio, the patients received additional DNR and BHAC for two to four more days. All patients achieving complete remission (CR) were randomized a second time to determine whether they would receive ubenimex. CR was obtained in 60.1 % of the fixed group and 63.6 % of the individualized group. Predicted 4-year relapse-free survival (RFS) was 9 % for the fixed group and 18 % for the individualized group. There were no statistically significant differences in CR and RFS between the fixed and individualized groups. In the ubenimex group, prolonged RFS was observed. Notably, gender was a prognostic factor in this study, as 102 female patients had a significantly higher CR rate (72.5 vs. 54.3 %, p = 0.0048) and better OS (24 vs. 14 % at 4 years, p = 0.018), compared with 140 male patients.

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Acknowledgments

We thank all participating physicians from the 55 institutions in the JALSG for their cooperation. This study was supported in part by a grant for Clinical Cancer Research from the Ministry of Health, Labor and Welfare of Japan (H20-007).

Author information

Authors and Affiliations

  1. Division of Hematology and Oncology, Nagoya City West Medical Center, 1-1, Hirate-cho 1-chome, Kita-ku, Nagoya, 462-8508, Japan

    Atsushi Wakita

  2. Department of Clinical Laboratory Science, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan

    Shigeki Ohtake

  3. Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan

    Satoru Takada

  4. Department of Hematology, Saitama Medical University International Medical Center, Hidaka, Japan

    Fumiharu Yagasaki

  5. Department of Medical Oncology and Immunology, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan

    Hirokazu Komatsu & Ryuzo Ueda

  6. The Department of Hematology, Atomic Bomb Disease Institute, Nagasaki University School of Medicine, Nagasaki, Japan

    Yasushi Miyazaki

  7. Department of Hematology, Aomori Prefectural Central Hospital, Aomori, Japan

    Kohmei Kubo

  8. Division of Hematology, First Department of Internal Medicine, Tokyo Medical University, Tokyo, Japan

    Yukihiko Kimura

  9. Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Akihiro Takeshita

  10. Department of Internal Medicine, Kobe Central Hospital of Insurance, Kobe, Japan

    Yoko Adachi

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

    Hitoshi Kiyoi & Tomoki Naoe

  12. Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan

    Takuhiro Yamaguchi

  13. Fourth Department of Internal Medicine, Mizonokuchi Hospital, Teikyo University School of Medicine, Kawasaki, Japan

    Minoru Yoshida

  14. Oncology Center, Hamamatsu University School of Medicine, Shizuoka, Japan

    Kazunori Ohnishi

  15. Division of Hematology, Tokyo Metropolitan Ohtsuka Hospital, Tokyo, Japan

    Shuichi Miyawaki

  16. Aichi Cancer Center, Nagoya, Japan

    Ryuzo Ohno

Authors
  1. Atsushi Wakita
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  2. Shigeki Ohtake
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  3. Satoru Takada
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  4. Fumiharu Yagasaki
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  5. Hirokazu Komatsu
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  6. Yasushi Miyazaki
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  7. Kohmei Kubo
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  8. Yukihiko Kimura
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  9. Akihiro Takeshita
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  10. Yoko Adachi
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  11. Hitoshi Kiyoi
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  12. Takuhiro Yamaguchi
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  13. Minoru Yoshida
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  14. Kazunori Ohnishi
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  15. Shuichi Miyawaki
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  16. Tomoki Naoe
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  17. Ryuzo Ueda
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  18. Ryuzo Ohno
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Corresponding author

Correspondence to Atsushi Wakita.

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For Japan Adult Leukemia Study Group (JALSG).

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Wakita, A., Ohtake, S., Takada, S. et al. Randomized comparison of fixed-schedule versus response-oriented individualized induction therapy and use of ubenimex during and after consolidation therapy for elderly patients with acute myeloid leukemia: the JALSG GML200 Study. Int J Hematol 96, 84–93 (2012). https://doi.org/10.1007/s12185-012-1105-y

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  • DOI: https://doi.org/10.1007/s12185-012-1105-y

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