[Immunity of gut-associated lymphoid tissue and the role of the oral immunotherapy in multi-disciplinary treatment of the digestive organ cancer]

Nihon Geka Gakkai Zasshi. 1989 Sep;90(9):1436-8.
[Article in Japanese]


In order to augment antitumor immunity of gut-associated lymphoid tissue in digestive organ cancer, oral administration of various biological response modifiers were studied using mice transplanted with cecal tumor. Among them OK-432 was the most effective and clinical application of oral OK-432 was studied. Autoradiogram and immunofluorescence studies showed the absorption of orally administered OK-432 from the gut. In phase I study oral OK-432 was much less toxic than other administration routes. Phase II study showed that oral OK-432 at various doses augmented antitumor immunity of the lymphocytes of peripheral blood and regional lymph node. In a multi-institutional study on postoperative adjuvant immunotherapy, 1011 gastric cancer patients were accumulated and randomized to compare the effects of oral and intradermal OK-432. In patients who underwent curative operation, 1-, 2- and 3-year survival rates (%) were 95, 88 and 82 for oral OK-432 group (n = 255), 88, 83 and 80 for the placebo group (n = 260), and 89, 79 and 73 for intradermal OK-432 group (n = 261). There was significant differences among cumulative survivals of three groups, and this life-prolonging effect of oral OK-432 was remarkable for stage II or III patients. These results demonstrate that oral immunotherapy with OK-432 is useful as an immunotherapy of digestive organ cancers.

Publication types

  • Clinical Trial
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Biological Products / therapeutic use*
  • Combined Modality Therapy
  • Digestive System / immunology*
  • Humans
  • Immunotherapy
  • Lymphoid Tissue / immunology*
  • Picibanil / therapeutic use*
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / therapy*
  • Survival Rate


  • Biological Products
  • Picibanil