title: Beneficial effects of protein-bound polysaccharide K plus tegafur/uracil in patients with stage II or III colorectal cancer: analysis of immunological parameters.
abstract: Protein-bound polysaccharide K (PSK) increased the 5-year disease-free survival rate and reduced the risk of recurrence in a randomised, controlled study for stage II and III colorectal cancer. In order to elucidate the disease-free survival benefits with PSK and what immunological markers could indicate a PSK responder, serial changes in immunological parameters were monitored in the study. PSK decreased the mean serum immunosuppressive acidic protein (IAP) level, and increased the mean population of natural killer (NK) cells compared with the controls. The 5-year disease-free and overall survival rate for patients with serum IAP values <or=500 microg ml(-1), which represents the normal value, were 75.5% (95% CI: 66.8-84.2%; p=0.016) and 85.1% (95% CI: 77.9-92.3%; p=0.032), respectively, in the PSK group compared with 57.5% (95% CI: 43.3-71.6%) and 70.2% (95% CI: 57.1-83.3%) in the control group. In patients with NK cell population >or=8% at 3 months after surgery, PSK conferred a significantly better (p=0.038) 5-year disease-free survival (86.7%; 95% CI: 74.5-98.8%) compared to the control group (60.0%; 95% CI: 29.6-90.4%). In the proportional hazards model, the presence of regional metastases (relative risk, 3.595; 95% CI: 1.518 to 8.518; p=0.004) and omission of PSK treatment (relative risk, 3.099; 95% CI: 1.202 to 7.990; p=0.019) were significant indicators of recurrence. PSK acts as an immunomodulatory activity and biochemical modulator in stage II or III colorectal cancer. Pre-operative serum IAP values <or=500 microg ml(-1) and an NK cell population >or=8% at 3 months after surgery are possible PSK response predictors.
authors.affiliation: Gunma Oncology Study Group, Gunma University, Graduate School of Medicine, Maebashi, Gunma 371-8511, Japan. sohwada@med.gunma-u.ac.jp
authors.forename: Susumu
authors.initials: S
authors.lastname: Ohwada
authors.forename: Tetsushi
authors.initials: T
authors.lastname: Ogawa
authors.forename: Fujio
authors.initials: F
authors.lastname: Makita
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Tanahashi
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Ohya
authors.forename: Naoki
authors.initials: N
authors.lastname: Tomizawa
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Satoh
authors.forename: Isao
authors.initials: I
authors.lastname: Kobayashi
authors.forename: Masaru
authors.initials: M
authors.lastname: Izumi
authors.forename: Izumi
authors.initials: I
authors.lastname: Takeyoshi
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Hamada
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Minaguchi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Togo
authors.forename: Tago
authors.initials: T
authors.lastname: Toshihiko
authors.forename: Toru
authors.initials: T
authors.lastname: Koyama
authors.forename: Masashi
authors.initials: M
authors.lastname: Kamio
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D039481:CD11b Antigen / Q000097:blood; D018959:CD57 Antigens / Q000097:blood; D016827:CD8 Antigens / Q000097:blood; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018655:Lymphocyte Count; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009363:Neoplasm Proteins / Q000097:blood; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011379:Prognosis; D016016:Proportional Hazards Models; D011509:Proteoglycans / Q000008:administration & dosage; D017452:Receptors, IgG / Q000097:blood; D012307:Risk Factors; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D039481:CD11b Antigen; D018959:CD57 Antigens; D016827:CD8 Antigens; D009363:Neoplasm Proteins; D011509:Proteoglycans; D017452:Receptors, IgG; C030193:immunosuppressive acidic protein; D005641:Tegafur; C010770:polysaccharide-K; D014498:Uracil