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The usefulness of pre- and post-operative adjuvant chemotherapy in colorectal cancer patients was studied by the North Kyushu Co-operative Study Group for Cancer Chemotherapy (21 participating institutions). Comparisons were made among group I given a tegafur suppository preoperatively+tegafur oral preparation postoperatively, group II given a tegafur suppository preoperatively+UFT oral preparation postoperatively and group III given a tegafur oral preparation postoperatively. No differences were seen in the incidence of postoperative complications depending on whether or not tegafur suppositories were administered preoperatively. There were also no differences in the symptom or incidence of side effects due to postoperative administration of tegafur or UFT. In a study of 5-FU concentration in the lymph nodes due to preoperative tegafur administration and recurrences, the concentration of 5-FU was significantly higher in the lymph nodes of cases without recurrences than in those with recurrences, and it was suggested that a relation exists between the concentration of agent and recurrences. The concentration of 5-FU in the lymph nodes of Dukes B patients was significantly higher in cases without recurrences than in those with recurrences. The non-recurrence rate (healthy rate) was better in the group given UFT postoperatively than in that administered tegafur postoperatively although the difference was not significant.

In an attempt to establish the optimum dose of HCFU, the effect of the presence of stomach on the absorption of HCFU and both the rise and maintenance of blood HCFU levels was evaluated in patients with gastric cancer (total gastrectomy group) and with colorectal cancer (non-gastrectomy group). The blood concentrations of HCFU fractions and 5-FU were determined in terms of pharmacokinetic parameters in these groups. The Tmax was significantly different between the two groups, with HCFU fraction and 5-FU levels that were significantly higher in the total gastrectomy group 30 minutes after administration. No differences were found in Cmax or AUC. There were no significant differences in Cmax or AUC among the various subgroups given different doses of HCFU (100, 150 and 200 mg) in either group, although dose-dependency was observed. Similar results were obtained in crossover tests. The 5-FU remained at an effective concentration of 0.05 microgram/ml, 4 hours after a single dose of 100 mg HCFU.

The North Kyushu Co-operative Study Group for Cancer Chemotherapy (21 participating facilities) carried out a comparative study of post-operative adjuvant chemotherapy in the treatment of 243 patients after surgery of gastric cancer in stages II, III and IV over 27 months period starting from October 1983. The patients were divided randomly into group A (treated with 20 mg of MMC on the day of the surgery and 10 mg of MMC on the following day, and with a daily dose 600 mg of orally administered tegafur starting from two weeks after the surgery. In addition to the above treatments, patients with Stage IV were treated with 10 mg of MMC every three months starting from four weeks after the surgery) and group B (treated with MMC in a similar manner to group A, and with 600m g of UFT instead of the tegafur). Thirty-three patients (13.6%) were excluded or dropped out, and the remaining 210 cases were analyzed. No severe side effects appeared in either of the groups, and a long-term administration was safe. The five-year survival rate among the radical surgery patient was significantly higher in the UFT group compared with the tegafur group (p less than 0.05). Significantly higher survival rate in the UFT group was observed (p less than 0.05) for the cases of poorly-differentiated adenocarcinoma. From the above results it appears that an addition of UFT to the treatment with MMC is useful in post-operative adjuvant chemotherapy for gastric cancer.

The present study was undertaken to evaluate the effect of postoperative adjuvant chemotherapy for 232 cases of gastric cancer by a co-operative study group consisting of 21 hospitals. The present paper describes the side effects and the 2-year survival rates in patients. Side effects observed during long-term treatment with Futraful or UFT were considered to be minor, although incidence of toxicity in the UFT group was slightly higher than in the Futraful group. As for 2-year survival, elevated survival was found in stage III cases of poorly differentiated adenocarcinoma. This suggested that UFT is more useful than Futraful.

A comparative multicenter study was carried out on postoperative adjuvant chemotherapy on 243 gastrectomy patients from October 1983 to December 1985. The medications were assigned at random to 2 groups of patients by the envelope method: group A (administered 20 mg of MMC on the day of surgery and 10 mg of MMC on the day after surgery, and started on tegafur at a dose of 600 mg/day 2 weeks after surgery); group B (similarly treated with MMC and started on UFT at a dose of 600 mg/day 2 weeks after surgery). Further, patients presenting in stage IV were administered MMC intravenously every 3 months, starting 4 weeks after surgery. The final drug effect evaluations were made in 210 patients excluding 33 dropouts (13.6%). The incidence of side effects was somewhat higher in group B than in group A, but their frequency was low and no serious symptoms were observed. For patients with poorly differentiated adenocarcinoma and were carried out curative operation, the 3-year survival rate was significantly higher in group B than in group A.