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.

Autor: Redmond HP; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., Neary PM; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., Jinih M; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., O'Connell E; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., Foley N; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., Pfirrmann RW; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., Wang JH; Surguvant Research Centre, Cork University Hospital, Cork, Ireland., O'Leary DP; Surguvant Research Centre, Cork University Hospital, Cork, Ireland. donaloleary@rcsi.ie.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2018 Aug 06; Vol. 18 (1), pp. 794. Date of Electronic Publication: 2018 Aug 06.
DOI: 10.1186/s12885-018-4641-x
Abstrakt: 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 ).
Databáze: MEDLINE
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