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RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer – the S.U.R.G.U.V.A.N.T. trial
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RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer – the S.U.R.G.U.V.A.N.T. trial
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RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer – the S.U.R.G.U.V.A.N.T. trial
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Journal Article
RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer – the S.U.R.G.U.V.A.N.T. trial
2018
Overview
Background
Peri-operative inflammation has been extensively highlighted in cancer patients as detrimental. Treatment strategies to improve survival for cancer patients through targeting peri-operative inflammation have yet to be devised.
Methods
We conducted a multi-centre, randomised controlled clinical trial using Taurolidine in non-metastatic colon cancer patients. Patients were randomly assigned to receive Taurolidine or a placebo. The primary endpoint for the study was the mean difference in day 1 IL-6 levels. Secondary clinical endpoints included rates of post-operative infections and tumor recurrence.
Results
A total of 293 patients were screened for trial inclusion. Sixty patients were randomised. Twenty-eight patients were randomised to placebo and 32 patients to Taurolidine. IL-6 levels were equivalent on day 1 post-operatively in both groups. However, IL-6 levels were significantly attenuated over the 7 day study period in the Taurolidine group compared to placebo (
p
= 0.04). In addition, IL-6 levels were significantly lower at day 7 in the Taurolidine group (p = 0.04). There were 2 recurrences in the placebo group at 2 years and 1 in the Taurolidine group. The median time to recurrence was 19 months in the Placebo group and 38 months in the Taurolidine group (
p
= 0.27). Surgical site infection was reduced in the Taurolidine treated group (
p
= 0.09).
Conclusion
Peri-operative use of Taurolidine significantly attenuated circulating IL-6 levels in the initial 7 day post-operative period in a safe manner. Future studies are required to establish the impact of IL-6 attenuation on survival outcomes in colon cancer.
Trial registration
The trial was registered with EudraCT (year = 2008, registration number =
005570–12
) and ISRCTN (year = 2008, registration number =
77,829,558
).
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Analysis
/ Anti-Inflammatory Agents - administration & dosage
/ Anti-Inflammatory Agents - adverse effects
/ Antineoplastic Agents - administration & dosage
/ Antineoplastic Agents - adverse effects
/ Biomedical and Life Sciences
/ Colonic Neoplasms - pathology
/ Female
/ Health Promotion and Disease Prevention
/ Humans
/ Inflammation - prevention & control
/ Inflammation Mediators - blood
/ Ireland
/ Male
/ Neoplasm Recurrence, Local - prevention & control
/ Oncology
/ Surgery
/ Surgical Wound Infection - prevention & control
/ Taurine - administration & dosage
/ Taurine - analogs & derivatives
/ Thiadiazines - administration & dosage
