Efficacy of adjuvant immunochemotherapy with OK-432 for patients with curatively resected gastric cancer: a meta-analysis of centrally randomized controlled clinical trials

J Immunother. 2002 Sep-Oct;25(5):405-12. doi: 10.1097/00002371-200209000-00004.


The benefit of immunochemotherapy employing a streptococcal preparation, OK-432 (Picibanil), in patients with curatively resected gastric cancer was reassessed by meta-analysis of data from 1,522 patients enrolled in six clinical trials with central randomization. All six trials began between 1985 and 1993, and patients were followed-up for at least 3 years after surgery and enrollment of the last patient. In these trials, standard chemotherapy was compared with the same chemotherapy plus OK-432. The endpoint was overall survival and intent-to-treat analysis was done without patient exclusion. Data were analyzed using the Mantel-Haenszel method. The 3-year survival rate for all eligible patients in the six trials was 67.5% in the immunochemotherapy group versus 62.6% in the chemotherapy group. The 3-year overall survival odds ratio was 0.81 (95% confidence interval: 0.65-0.99). The treatment effect was shown to be statistically significant (p = 0.044). The results of this meta-analysis suggest that immunochemotherapy after surgery with OK-432 can improve the survival of patients with curatively resected gastric cancer.

Publication types

  • Meta-Analysis

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Combined Modality Therapy
  • Humans
  • Immunotherapy
  • Odds Ratio
  • Picibanil / therapeutic use*
  • Stomach Neoplasms / drug therapy
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / surgery
  • Stomach Neoplasms / therapy*
  • Survival Rate


  • Antineoplastic Agents
  • Picibanil