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Nationwide randomized comparative study of daunorubicin and aclarubicin in combination with behenoyl cytosine arabinoside, 6-mercaptopurine, and prednisolone for previously untreated acute myeloid leukemia

  • Original Articles
  • Daunorubicin, Aclarubicin, DMP, Adult Acute Myeloid Leukemia
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Abstract

Aclarubicin was evaluated in combination chemotherapy for adult acute myeloid leukemia in a randomized trial involving 58 institutions throughout Japan. Behenoyl cytosine arabinoside (BH-AC)•daunorubicin, 6-mercaptopurine, and prednisolone (DMP) was compared with BH-AC•aclarubicin, 6-mercaptopurine, and prednisolone (AMP). In the 360 evaluable cases among the 433 cases enrolled, complete remission (CR) rates were 63.7% (116/182) for BH-AC•DMP and 53.9% (96/178) for BH-AC•AMP (P=0.0587). Median survival periods and 7-year survival rates were 15.8 months and 19.3% for BH-AC•DMP and 9.5 months and 20.2% for BH-AC•AMP (P=0.0091 according to the generalized Wilcoxon test [GW],P=0.196 according the log-rank test [LR]). Median disease-free survival periods were 15.4 months for BH-AC⊙DMP and 14.1 months for BH-AC•AMP (P=0.851 by GW,P=0.439 by LR). Among the 346 cases of extramurally confirmed FAB subtypes, CR rates were 67.9% (19/28) with BH-AC•DMP and 31.8% (7/22) with BH-AC•AMP for subtype M3 (P=0.011) and 63.3% (93/147) with BH-AC•DMP and 56.8% (84/148) with BH-AC•AMP (P=0.254) for subtypes M1, M2, M4, and M5. Diarrhea, ileus, pneumonia, and renal failure were more frequent with BH-AC•AMP than with BH-AC•DMP. The results indicate, at least on the basis of the long-term outcome, that BH-AC•AMP has antileukemic effects on subtypes M1, M2, M4, and M5 that are comparable with those of BH-AC•DMP.

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Authors and Affiliations

  1. Department of Internal Medicine, Chubu National Hospital, 36-3, Gengo, Morioka-cho, 474, Obu-shi, Aichiken, Japan

    Eiichi Nagura

  2. Nagoya National Hospital, Nagoya, Japan

    Kiyoji Kimura

  3. Department of Internal Medicine, Branch Hospital, Nagoya University School of Medicine, Nagoya, Japan

    Kazumasa Yamada

  4. Aichi Cancer Center Hospital, Nagoya, Japan

    Kazuo Ohta

  5. Third Department of Internal Medicine, Gunma University School of Medicine, Maebashi, Japan

    Tadashi Maekawa

  6. Third Department of Internal Medicine, Faculty of Medicine, University of Tokyo, Tokyo, Japan

    Fumimaro Takaku

  7. First Department of Internal Medicine, School of Medicine, Kyoto University, Kyoto, Japan

    Haruto Uchino

  8. Fifth Department of Internal Medicine, Center for Adult Disease, Osaka, Japan

    Toru Masaoka

  9. First Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan

    Ichita Amaki

  10. First Department of Internal medicine, Clinical Laboratory, Nagoya University School of Medicine, Nagoya, Japan

    Kohei Kawashima

  11. First Department of Internal Medicine, Fukushima Medical College, Fukushima, Japan

    Shigeo Kariyone

  12. Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

    Keisuke Toyama

  13. Department of Internal Medicine, Atomic Disease Institute, Nagasaki University, Nagasaki, Japan

    Michito Ichimaru

  14. Third Department of Internal Medicine, Nippon Medical School, Tokyo, Japan

    Takeo Nomura

  15. Department of Chemotherapy, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan

    Yasunobu Sakai

  16. Second Department of Internal Medicine, Kumamoto University School of Medicine, Kumamoto, Japan

    Kiyoshi Takatsuki

  17. Department of Public Health, Gifu University School of Medicine, Gifu, Japan

    Nobuyuki Hamajima

Authors
  1. Eiichi Nagura
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  2. Kiyoji Kimura
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  3. Kazumasa Yamada
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  5. Tadashi Maekawa
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  9. Ichita Amaki
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  10. Kohei Kawashima
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  13. Michito Ichimaru
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  14. Takeo Nomura
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  15. Yasunobu Sakai
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  16. Kiyoshi Takatsuki
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  17. Nobuyuki Hamajima
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Additional information

This work was supported by a grant-in-aid from the Japanese Foundation for Multidisciplinary Treatment of Cancer (Cooperative Project 2)

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Nagura, E., Kimura, K., Yamada, K. et al. Nationwide randomized comparative study of daunorubicin and aclarubicin in combination with behenoyl cytosine arabinoside, 6-mercaptopurine, and prednisolone for previously untreated acute myeloid leukemia. Cancer Chemother. Pharmacol. 34, 23–29 (1994). https://doi.org/10.1007/BF00686107

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  • DOI: https://doi.org/10.1007/BF00686107

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