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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dc.contributor.author Redmond, H. Paul
dc.contributor.author Neary, Peter M.
dc.contributor.author Jinih, Marcel
dc.contributor.author O'Connell, Emer
dc.contributor.author Foley, Niamh
dc.contributor.author Pfirrmann, Rolf W.
dc.contributor.author Wang, Jiang H.
dc.contributor.author O'Leary, D. Peter
dc.date.accessioned 2019-09-09T11:58:44Z
dc.date.available 2019-09-09T11:58:44Z
dc.date.issued 2018-08-06
dc.identifier.citation Redmond, H.P., Neary, P.M., Jinih, M., O’Connell, E., Foley, N., Pfirrmann, R.W., Wang, J.H. and O’Leary, D.P., 2018. RandomiSed clinical trial assessing Use of an anti-inflammatoRy aGent in attenUating peri-operatiVe inflAmmatioN in non-meTastatic colon cancer–the SURGUVANT trial. BMC cancer, 18(1),(794). DOI:10.1186/s12885-018-4641-x en
dc.identifier.volume 18 en
dc.identifier.issued 1 en
dc.identifier.startpage 1 en
dc.identifier.endpage 8 en
dc.identifier.issn 1471-2407
dc.identifier.uri http://hdl.handle.net/10468/8486
dc.identifier.doi 10.1186/s12885-018-4641-x en
dc.description.abstract 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). en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central Ltd. en
dc.relation.uri https://doi.org/10.1186/s12885-018-4641-x
dc.rights © 2018 The Author(s) en
dc.rights.uri https://creativecommons.org/licenses/by/4.0/ en
dc.subject Inflammation en
dc.subject Colon cancer en
dc.subject Peri-operative en
dc.subject Metastasis en
dc.subject Recurrence en
dc.title 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 en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Henry Paul Redmond, Department of Surgery (Academic), University College Cork, Cork, Ireland. +353-21-490-3000 en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder Geistlich Pharma AG, Switzerland en
dc.description.status Peer reviewed en
dc.identifier.journaltitle BMC Cancer en
dc.identifier.articleid 794 en


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