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Clinical Trial
. 2004 Mar;19(2):157-64.
doi: 10.1007/s00384-003-0532-x. Epub 2003 Sep 12.

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

Katsuki Ito  1 , Hiroaki Nakazato, Akihiko Koike, Hiroshi Takagi, Shigetoyo Saji, Shozo Baba, Masayoshi Mai, Jun-ichi Sakamoto, Yasuo Ohashi; Study Group of Immunochemotherapy with PSK for Colon Cancer
Affiliations
Clinical Trial

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

Katsuki Ito et al. Int J Colorectal Dis. 2004 Mar.

Abstract

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.

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