Long-term effect of 5-fluorouracil enhanced by intermittent administration of polysaccharide K after curative resection of colon cancer. A randomized controlled trial for 7-year follow-up

Int J Colorectal Dis. 2004 Mar;19(2):157-64. doi: 10.1007/s00384-003-0532-x. Epub 2003 Sep 12.


Background and aims: The efficacy of a biological response modifier polysaccharide K in adjuvant immunochemotherapy was evaluated in primary colon cancer patients with macroscopic Dukes' C after curative resection.

Patients and methods: Employing the minimization method using three factors (lymph node metastases, preoperative serum CEA level, and institution), 446 patients were allocated into groups P and C. Group P received immunochemotherapy, oral PSK (3 g per day) followed by oral 5-FU (200 mg/body per day), while group C received only intermittent chemotherapy, oral 5-FU (200 mg per day) followed by 4-week rest. Both groups received ten courses.

Results: Survival for cancer death was significantly higher in group P than in group C, but there was no difference in 7-year disease-free survival or overall survival had.

Conclusion: Repeated alternating administration with PSK followed by 5-FU can improve survival for cancer death.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / surgery
  • Adjuvants, Immunologic / administration & dosage*
  • Administration, Oral
  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / mortality
  • Colorectal Neoplasms / surgery
  • Combined Modality Therapy
  • Disease-Free Survival
  • Female
  • Fluorouracil / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Metastasis
  • Neoplasm Staging
  • Proteoglycans / administration & dosage*
  • Survival Rate
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Antimetabolites, Antineoplastic
  • Proteoglycans
  • polysaccharide-K
  • Fluorouracil