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A randomized trial of chemoimmunotherapy of acute nonlymphocytic leukemia in adults using a protein-bound polysaccharide preparation

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Summary

The effect of immunotherapy with a protein-bound polysaccharide preparation termed PSK on remission duration and survival of adults with acute nonlymphocytic leukemia (ANLL) was studied in a prospective randomized cooperative trial. After having achieved complete remission and receiving a consolidation therapy, 73 patients were randomized either to maintenance chemotherapy or to maintenance chemotherapy plus immunotherapy with PSK. Ultimately 36 patients in the chemotherapy group and 31 in the chemoimmunotherapy group were evaluable. Six months after the last entry, immunotherapy with PSK showed a borderline beneficial effect on remission duration (P=0.089) and on duration of survival (P=0.062). When the data were analyzed 12, 18, and 24 months after the last entry there were no significant differences in duration of remission and survival between the two groups. However, analysis of the data of patients who had maintained complete remission for more than 270 days revealed that immunotherapy had a suggestive beneficial effect (P=0.105), prolonging the 50% remission period by 418 days (885 vs 467 days). Thus, immunotherapy with PSK seems to be active in the treatment of adult ANLL when used for maintenance therapy in combination with chemotherapy, especially in patients with a good prognosis.

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Authors and Affiliations

  1. First Department of Medicine, Nagoya University Hospital, 65 Tsurumaicho, Showaku, Nagoya, Japan

    Ryozo Ohno

  2. Department of Medicine, Nagoya University Branch Hospital, Higashiku, Nagoya, Japan

    Kazumasa Yamada

  3. Department of Medicine, The Center for Adult Diseases, Higashinariku, Osaka, Japan

    Toru Masaoka & Hiroyuki Nakamura

  4. Department of Medicine, Nihon University Hospital, Itabashiku, Tokyo, Japan

    Toshiteru Ohshima & Ichita Amaki

  5. Department of Medicine, National Nagoya Hospital, Nakaku, Nagoya, Japan

    Yutaka Hirota & Kiyoji Kimura (Chairman of the study group)

  6. Department of Chemotherapy, Cancer Chemotherapy Center, Toshimaku, Tokyo, Japan

    Noboru Horikoshi

  7. Department of Medicine, Kinki University Hospital, Sayamacho, Osaka, Japan

    Atsushi Horiuchi, Mineya Tanaka & Kazuo Tsubaki

  8. Department of Chemotherapy, Komagome Hospital, Bunkyoku, Tokyo, Japan

    Kuniyuki Imai & Yasunobu Sakai

  9. Department of Medicine, Okayama University Hospital, Shikadacho, Okayama, Japan

    Ikuro Kimura & Koichi Kitajima

  10. Department of Medicine, Fukui Medical School Hospital, Matsuoka, Fukui, Japan

    Toru Nakamura

  11. Department of Medicine, Ehime University Hospital, Onsengun, Ehime, Japan

    Yoshiro Ohta

  12. Department of Medicine, Kyoto University Hospital, Sakyoku, Kyoto, Japan

    Haruto Uchino

  13. Department of Pharmacology, Ehime University School of Medicine, Onsengun, Ehime, Japan

    Nobuya Ogawa (Controller and statistician of the study)

Authors
  1. Ryozo Ohno
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  2. Kazumasa Yamada
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  3. Toru Masaoka
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  4. Toshiteru Ohshima
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  5. Ichita Amaki
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  6. Yutaka Hirota
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  7. Noboru Horikoshi
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  8. Atsushi Horiuchi
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  9. Kuniyuki Imai
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  10. Ikuro Kimura
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  11. Koichi Kitajima
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  12. Hiroyuki Nakamura
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  13. Toru Nakamura
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  14. Yoshiro Ohta
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  15. Yasunobu Sakai
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  16. Mineya Tanaka
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  17. Kazuo Tsubaki
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  18. Haruto Uchino
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  19. Nobuya Ogawa
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  20. Kiyoji Kimura
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Ohno, R., Yamada, K., Masaoka, T. et al. A randomized trial of chemoimmunotherapy of acute nonlymphocytic leukemia in adults using a protein-bound polysaccharide preparation. Cancer Immunol Immunother 18, 149–154 (1984). https://doi.org/10.1007/BF00205503

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  • DOI: https://doi.org/10.1007/BF00205503

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