POSTOPERATIVE CHEMOTHERAPY INCLUDING INTRAPERITONEAL AND INTRADERMAL ADMINISTRATION OF THE STREPTOCOCCAL PREPARATION OK-432 FOR PATIENTS WITH GASTRIC-CANCER AND PERITONEAL DISSEMINATION - A PROSPECTIVE RANDOMIZED STUDY

We studied the effects on survival time of postoperative immuno-chemot herapy, including the streptococcal preparation OK-432, in patients wi th gastric cancer and synchronous peritoneal dissemination. The patien ts were prospectively randomized and a valid statistical assessment co uld be made for 109. Patients randomized to group B received therapy t hat is widely used in Japan to treat patients with gastric cancer: mit omycin C (MMC) and UFT, a combination of tegafur and uracil in a molar ratio of 1:4, for 1 year. Patients randomized to group A received the same drugs as were given to group B patients plus OK-432 i.p. for 7 d ays, beginning on postoperative day 0, and OK-432 by intradermal injec tion for 1 year, at 2-week intervals. There were no differences betwee n the two groups in any known prognostic factor or in the dose of any drug administered except for OK-432. There was no difference in the to xicity rate between the groups. In this negative trial, there was no i mprovement in survival time with the addition of OK-432 to MMC and UFT for patients with gastric cancer and peritoneal dissemination.