A randomized trial of chemoimmunotherapy of acute nonlymphocytic leukemia in adults using a protein-bound polysaccharide preparation |
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| Authors: | Ohno Ryozo Yamada Kazumasa Masaoka Toru Ohshima Toshiteru Amaki Ichita Hirota Yutaka Horikoshi Noboru Horiuchi Atsushi Imai Kuniyuki Kimura Ikuro Kitajima Koichi Nakamura Hiroyuki Nakamura Toru Ohta Yoshiro Sakai Yasunobu Tanaka Mineya Tsubaki Kazuo Uchino Haruto Ogawa Nobuya Kimura Kiyoji |
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| Institution: | (1) First Department of Medicine, Nagoya University Hospital, 65 Tsurumaicho, Showaku, Nagoya, Japan;(2) Department of Medicine, Nagoya University Branch Hospital, Higashiku, Nagoya, Japan;(3) Department of Medicine, The Center for Adult Diseases, Higashinariku, Osaka, Japan;(4) Department of Medicine, Nihon University Hospital, Itabashiku, Tokyo, Japan;(5) Department of Medicine, National Nagoya Hospital, Nakaku, Nagoya, Japan;(6) Department of Chemotherapy, Cancer Chemotherapy Center, Toshimaku, Tokyo, Japan;(7) Department of Medicine, Kinki University Hospital, Sayamacho, Osaka, Japan;(8) Department of Chemotherapy, Komagome Hospital, Bunkyoku, Tokyo, Japan;(9) Department of Medicine, Okayama University Hospital, Shikadacho, Okayama, Japan;(10) Department of Medicine, Fukui Medical School Hospital, Matsuoka, Fukui, Japan;(11) Department of Medicine, Ehime University Hospital, Onsengun, Ehime, Japan;(12) Department of Medicine, Kyoto University Hospital, Sakyoku, Kyoto, Japan;(13) Department of Pharmacology, Ehime University School of Medicine, Onsengun, Ehime, Japan |
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| Abstract: | 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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