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Randomized controlled study of postoperative adjuvant immunochemotherapy with Nocardia rubra cell wall skeleton (N-CWS) and Tegafur for gastric carcinoma

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Summary

We performed a randomized controlled study of postoperative adjuvant immunochemotherapy with Nocardia rubra cell wall skeleton (N-CWS) and Tegafur for gastric carcinoma between September 1979 and March 1983. A total of 309 patients were entered into this trial. Of the 309 patients, there were 98 evaluable patients in the chemotherapy group and 115 evaluable patients in the immunochemotherapy group. In both groups, Tegafur was given as chemotherapy at a daily dose of 400 to 800 mg, starting at 24–29 days after gastrectomy. In the immunochemotherapy group, 400 μg of N-CWS was injected i. d. within the 2nd postoperative week. It was given weekly during the first month and subsequently monthly for as long as practicable. The patients were surveyed for length of survival in March 1985. The postoperative survival rate was analyzed for all cases, and for patients with various histopathological stages of carcinoma for comparison between the two treatment groups. No statistical difference was detected between the two groups in terms of age, sex, surgical curabilities, or stage of carcinoma. The overall survival rate for all patients was significantly higher in the immunochemotherapy group than in the chemotherapy group (p<0.05). With stage III plus IV disease, 53 patients from the chemotherapy group and 61 patients from the immunochemotherapy group were included for the analysis. As a consequence, a highly significant survival rate was observed in patients with stage III plus IV carcinoma in the immunochemotherapy group (p<0.005) as compared to the chemotherapy group. The overall 5-year (1800 days) survival rate after surgical treatment was 60.2% for the chemotherapy group and 73.2% for the immunochemotherapy group. In patients with stage III plus IV disease, the 5-year survival rates of the two treatment groups were 28.8% and 52.4%, respectively. Accordingly, the 50% survival period of patients with stage III plus IV cancer was 1800 days or more in the immunochemotherapy group, whereas it was only 722 days in the chemotherapy group. These results emphasize the effectiveness of N-CWS as an adjuvant immunotherapeutic agent in postoperative gastric cancer patients.

The main side effects of N-CWS were skin lesions in the injected sites and fever, but these were temporary and not serious.

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Authors and Affiliations

  1. Institute of Clinical Medicine, University of Tsukuba, 305, Ibaraki, Japan

    Shohei Koyama, Azusa Ozaki, Yoji Iwasaki, Takao Sakita & Toshiaki Osuga

  2. Mito National Hospital, 310, Mito, Japan

    Akira Watanabe & Masanori Suzuki

  3. Toride Kyodo Hospital, 302, Toride, Japan

    Tsuneo Kawasaki

  4. Tokyo Medical College, Kasumigaura Hospital, 300-03, Ibaraki, Japan

    Tetsuo Soma & Takafumi Tabuchi

  5. Mito Saiseikai Hospital, 310, Mito, Japan

    Muneharu Nakayama

  6. Ibaraki Prefectural Center Hospital, 309-17, Tomobe, Japan

    Sumihiko Koizumi

  7. Kensei Hospital, 309-12, Ibaraki, Japan

    Koichi Yokoyama & Tomohiko Uchida

  8. Tsukuba Gakuen Hospital, 305, Ibaraki, Japan

    Kazuo Orii

  9. Faculty of Medicine, University of Tokyo, 113, Tokyo, Japan

    Tsuneo Tanaka

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  1. Shohei Koyama
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Koyama, S., Ozaki, A., Iwasaki, Y. et al. Randomized controlled study of postoperative adjuvant immunochemotherapy with Nocardia rubra cell wall skeleton (N-CWS) and Tegafur for gastric carcinoma. Cancer Immunol Immunother 22, 148–154 (1986). https://doi.org/10.1007/BF00199130

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  • DOI: https://doi.org/10.1007/BF00199130

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