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.
OBJECTIVE
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.


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.


CONCLUSIONS
Repeated alternating administration with PSK followed by 5-FU can improve survival for cancer death.
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000284:Administration, Oral; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011509:Proteoglycans / Q000008:administration & dosage*; D015996:Survival Rate; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000964:Antimetabolites, Antineoplastic; D011509:Proteoglycans; C010770:polysaccharide-K; D005472:Fluorouracil