[A controlled study of surgical adjuvant chemoimmunotherapy with FT-207 and OK-432 for advanced stomach cancer: the fourth study]

A prospective randomized trial of surgical adjuvant chemoimmunotherapy was conducted in patients who had undergone palliative gastrectomy for previously untreated advanced stomach cancer. Immediately after surgery, one hundred and forty-seven patients were randomized to receive either chemoimmunotherapy with FT-207 plus OK-432 (group A) or chemotherapy with only FT-207 (group B). The number of patients subjected to this analysis was 134 cases (group A: 70 cases, group B: 64 cases) because thirteen patients were excluded. FT-207 was administered orally and OK-432 was administered intracutaneously. There were no differences in the background factors influencing survival time between the two groups. While the survival rate of group A patients was higher than that of group B patients, the difference in the survival rate between the two study groups was not statistically significant. However, in patients with less differentiated cancer (poorly differentiated adenocarcinoma, signet-ring cell carcinoma) the survival rate of group A patients was significantly (p less than 0.05) higher than that of group B patients. The results of the present study show that OK-432 administered intracutaneously is effective in elevating the survival rate of patients receiving chemotherapy with FT-207 for advanced stomach cancer (especially for less differentiated cancer).