[A randomized controlled trial of surgical adjuvant therapy with mitomycin C, 5-fluorouracil and OK-432 in patients with gastric cancer]

Gan To Kagaku Ryoho. 1986 Jun;13(6):2134-40.
[Article in Japanese]


The effect of postoperative immunochemotherapy with mitomycin C (MMC), 5-fluorouracil (5-FU) and OK-432 was evaluated as an adjuvant therapy after curative resection for gastric cancer. Immediately after surgery, patients were randomly allocated to the following three treatments: (A) chemotherapy with MMC and 5-FU (32 cases); (B) chemoimmunotherapy with MMC, 5-FU and OK-432 (33 cases); and (C) surgery alone as control (34 cases). There were no significant differences in the background factors influencing survival time among the groups, and there was no dose-distribution of chemotherapeutic agents between groups A and B. While the differences were not statistically significant, the survival rate and disease-free interval of group B were better than those of groups A or C. Side effects such as gastroenteric disorder, leukopenia (less than 3,000/mm3), thrombocytopenia (less than 7 X 10(4)/mm3) and increase of serum transaminase level (GPT greater than or equal to 100 units) were less frequently observed in group B than in group A. The results of the present study seemed to indicate that chemoimmunotherapy with OK-432 may be effective for surgical adjuvant therapy.

Publication types

  • Clinical Trial
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Biological Products / administration & dosage*
  • Combined Modality Therapy
  • Female
  • Fluorouracil / administration & dosage
  • Gastrectomy* / methods
  • Humans
  • Lymph Node Excision
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Mitomycin
  • Mitomycins / administration & dosage
  • Picibanil / administration & dosage*
  • Postoperative Period
  • Random Allocation
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / surgery
  • Stomach Neoplasms / therapy*


  • Biological Products
  • Mitomycins
  • Picibanil
  • Mitomycin
  • Fluorouracil