Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil (UFT) as an adjuvant in stage II and III colorectal cancer. Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT, or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients, 205 with stage II (n ¼ 123) or III (n ¼ 82) were analysed. The 5-year disease-free survival was 73.0% (95% CI 65.6 -80.4%) with PSK (n ¼ 137) and 58.8% (95% CI 47.1 -70.5%) in the controls (n ¼ 68) (P ¼ 0.016). POLYSACCHARIDE K reduced the recurrence by 43.6% (95% CI 4.5 -66.7%) and mortality by 40.2% (95% CI À12.5 to 68.3%). The 5-year survival was 81.8% (95% CI 75.3 -88.2%) in the PSK group and 72.1% (95% CI 61.4 -82.7%) in the control group (P ¼ 0.056). In stage III patients, disease-free and overall survivals in patients receiving PSK were increased significantly: 60.0% (95% CI 47.1 -72.9%) and 74.6% (95% CI 63.0 -86.1%) in the PSK group as compared with 32.1% (95% CI 14.8 -49.4%) and 46.4% (95% CI 28.0 -64.9%) in the controls (P ¼ 0.002 and 0.003, respectively). Polysaccharide K prevented recurrence, particularly lung metastases (P ¼ 0.02; odds ratio 0.27; 95% CI 0.09 -0.77). In the models, the presence of regional metastases (relative risk, 2.973; 95% CI 1.712 -5.165; Po0.001), omission of PSK (relative risk, 2.106; 95% CI 1.221 -3.633; P ¼ 0.007), and higher primary tumour (relative risk, 4.398; 95% CI 1.017 -19.014; P ¼ 0.047) were each significant indicators of recurrence. Adverse effects were mild and compliance was good. Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer, and increased survival in stage III.

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