Abstract: Objective To study the effect of perioperative immunomodulatory therapy on postoperative recurrence of rectal
cancer. Methods This prospective study was conducted among 238 rectal/anal cancer patients undergoing intersphincteric
resection at our center between January, 2010 and January, 2011, among whom 150 were eligible to be included and completed
the study. The 150 patients were randomized in a double-blinded fashion into 3 equal groups to receive immunomodulatory
therapy with 8 mg/kg celecoxib (group A), 0.4 mg/kg Sou-Medrol (group B), or placebo (group C), given daily from 5 days
before surgery to 5 days after surgery, and the postoperative cancer recurrence were compared. Results At 3 days after the
operation, the 3 groups showed significantly different C-reactive protein (CRP) levels, which decreased obviously in all the 3
groups compared with those at 1 day following the operation (P=0.022), especially in group B. The levels of interleukin-6 (IL-6)
at 3 days after the operation also differed significantly between the 3 groups but were lower in all the 3 groups than those at 1
day after the operation (P=0.046), and this reduction was the most obvious in group A. COX-2 expression differed significantly
between the 3 groups (P=0.017), among which group A showed the most obvious suppression of COX-2 expression. During the
follow-up for a mean of 45 months, no significant difference in the recurrence rate was found between the 3 groups (P=0.549)．
Conclusion With a lower efficacy than Sou-Medrol in decreasing postoperative inflammation, celecoxib produces a better
effect in inhibiting COX-2 expression, but it does not lower postoperative recurrence rate of rectal cancer.