[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).
D000284:Administration, Oral; D000368:Aged; D001688:Biological Products / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives*; D005743:Gastrectomy; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010844:Picibanil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011182:Postoperative Care; D011446:Prospective Studies; D011897:Random Allocation; D013274:Stomach Neoplasms / Q000628:therapy*; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D001688:Biological Products; D005641:Tegafur; D010844:Picibanil; D005472:Fluorouracil