The anti-inflammatory and anti-neoplastic agent taurolidine significantly decreased IL-6 levels in patients undergoing colon cancer surgery, potentially improving outcomes, according to results of a randomized, placebo-controlled controlled trial.
“The Surguvant trial is the first of its kind to be performed worldwide showing that it is safe to use taurolidine in this critical period of time for cancer patients where they are exposed to an inflammatory response necessary for wound healing, but which can be potentially detrimental to their cancer outcome,” Paul Redmond, BSc, MCh, FRCSI, FRCSI(gen), FRCS(Eng), FRCP&S(Glas)Hon, FACS, council member of Royal College of Surgeons in Ireland and chair of surgery at Cork University Hospital in Ireland, said in a press release. “Now that we have proven the safety of this treatment strategy, it remains to be demonstrated if targeting the inflammatory response to surgery will lead to improved outcomes for cancer patients. We hope to do this in much larger future trials.”
Redmond and colleagues assessed the use of taurolidine (Geistlich Pharma AG) on perioperative inflammation in patients with nonmetastatic colon cancer undergoing resection of their primary tumor.
The study included data from 60 patients receiving treatment at Cork University Hospital, Bons Secours Cork and Mercy University Hospital.
Researchers randomly assigned patients in a 1:1 allocation ratio to placebo (n = 28) or 2% taurolidine solution (n = 32) four times daily for 4 days.
The mean difference in day 1 IL-6 levels served as the primary endpoint. Rates of postoperative infection and tumor recurrence were secondary endpoints.
Median follow-up at the time of data cutoff was 32 months (range, 24-76) in the placebo group and 37 months (range, 24-76) in the treatment group.
Although IL-6 levels were the same on day 1 after surgery between the two groups, taurolidine treatment led to a significant decrease in IL-6 levels over the course of the 7-day postoperative period and on day 7 (P = .04 for both).
Moreover, taurolidine was associated with a reduction in surgical site infection (P = .09).
Three tumor recurrences occurred in each of the groups. Median time to recurrence was 19 months with placebo vs. 38 months with taurolidine.
Additional trials are needed to further assess the effect of IL-6 attenuation on colon cancer survival outcomes, according to the researchers. – by Jennifer Southall
Disclosures: The study was funded by a grant from Geistlich Pharma AG in Wolhusen, Switzerland. Redmond and the other study authors report no relevant financial disclosures.