[Effect of levamisole in postoperative adjuvant immunochemotherapy of stomach cancer--randomized controlled study of MMC-tegafur combination therapy with or without levamisole. 1].

The effects of levamisole used in combination with Mitomycin C and Tegafur in patients with resectable stomach cancer were investigated in 10 cooperative institutes. The patients were randomly allocated to the treatment with either control or levamisole by envelope method. Levamisole group was treated with Mitomycin C (day 0, 20 mg, day 1, 10 mg, one shot i.v.), Tegafur (600 mg/day, p.o.) and levamisole (150 mg/day, p.o.). Levamisole was administered 3 consecutive days prior to surgery, and 3 consecutive days every fortnight after surgery. The control group was administered Mitomycin C and Tegafur. The both drugs were administered by the same method as above. Two hundred and twenty-two patients were entered in this trial. However, with the exclusion of 67 patients, the eligible patients were 155, consisting of 77 in the control group and 78 in the levamisole group. In stage III patients, the disease-free interval and survival time were significantly prolonged in the levamisole group compared to the control group (generalized Wilcoxon test p less than 0.05). The side effects were observed a little more frequently in the levamisole group. However, there was no significant difference. From this result, it can be considered that levamisole is effective in delaying recurrence and in prolonging survival time of the patients when used in combination with adjuvant chemotherapy after resection of stomach cancer.