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.
Adjuvant therapy using a combination of oral protein-bound polysaccharide K and tegafur/uracil is highly effective in preventing the recurrence of colorectal cancer in Stage II or III patients, and increases overall survival in pathological TNM Stage III. These results will be a sufficient proof to conduct a larger study to compare tegafur/uracil/protein-bound polysaccharide K with 5-fluorouracil/leucovorin.
Between January 1993 and October 1995, 34 patients with anthracycline-resistant advanced breast cancer were treated with a combination chemoendocrine therapy of mitoxantrone (MIT), doxifluridine (5'-DFUR) and medroxyprogesterone acetate (MPA). Of 34 patients, 28 were evaluable for efficacy of this combination therapy, and 30 including 2 for whom data were incomplete were assessed for adverse drug reactions. Adriamycin (ADM) was used for pretreatment in 12 patients, 4'-epi-ADM in 6, and THP-ADM in 12. In the eligible patients, 8.0 mg/m2 MIT was administered intravenously every 4 weeks, and 600 mg MPA and 600 mg 5'-DFUR were given orally every day. The median follow-up period was 25 weeks (range 2-90 weeks). The median cumulative dose of mitoxantrone was 66 mg (range 12-121 mg). Of the 28 patients, 11 (39.3%) responded to this combination therapy. As for response in relation to predominant site of lesion, 1 of 5 soft tissue lesions (20%) and 8 of 12 bone metastases (66.7%) showed a partial response, and one complete response and one partial response (25.0%) were seen in eight lung lesions. None of three pleural lesions responded to this therapy. The median duration of response was 31 +/- weeks (range 12-82 weeks). Adverse drug reactions were controllable or tolerable. Combined chemoendocrine therapy with a low dose of MIT is a well-tolerated and moderately effective regimen for the treatment of anthracycline-resistant advanced breast cancer.
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