[A prospective randomized controlled trial of Sapylin combined with chemotherapy for advanced colon cancer following radical operation].
OBJECTIVE
To evaluate the effect of Sapylin combined with intraperitoneal and systemic chemotherapy for advanced colon cancer following radical operation on local recurrence, hepatic metastasis, and overall survival rate.


METHODS
From Jan. 2004 to Dec. 2005,132 patients with stage II or III colon carcinoma after radical operation were randomly divided into two groups: Sapylin combined with chemotherapy(Sapylin) group and the control group. Toxic reaction, local recurrence, hepatic metastasis, and overall survival rate between two groups were compared.


RESULTS
Both groups successfully completed the trial. There was no significant difference in toxic reaction between two groups, the recurrence and hepatic metastasis rate in Sapylin group were lower than those in the control group(9/60, 15.0% vs. 22/72, 30.6%; 11/60,18.3% vs. 22/72, 34.7%, respectively), which were statistically significant (P<0.05 respectively). The 3- year survival rate in Sapylin group was higher than that in control group(73.3% vs. 54.2%), which was statistically significant (P<0.05).


CONCLUSIONS
Sapylin combined with intraperitoneal and systemic chemotherapy can effectively decrease local recurrence and hepatic metastasis,and improve the survival in patients with advanced colon cancer following radical operation.
Chen
You-Ting
YT
Department of General Surgery, The First Affiliated Hospital, Fujian Medical University, Fuzhou 350005, China. chenyt1381@medmail.com.cn
Shi
Zheng
Z
Chen
Zhi-Shan
ZS
He
Qing-Liang
QL
Lin
Yong-Kun
YK
D000328:Adult; D000368:Aged; D001688:Biological Products / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011184:Postoperative Period; D011446:Prospective Studies; D013297:Streptococcus pyogenes; D015996:Survival Rate
D001688:Biological Products; C569879:streptococcal preparation 722