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

Simple item page
dc.contributor.authorRedmond, H. Paul
dc.contributor.authorNeary, Peter M.
dc.contributor.authorJinih, Marcel
dc.contributor.authorO'Connell, Emer
dc.contributor.authorFoley, Niamh M.
dc.contributor.authorPfirrmann, Rolf W.
dc.contributor.authorWang, Jiang H.
dc.contributor.authorO'Leary, D. Peter
dc.contributor.funderGeistlich Pharma AG, Switzerlanden
dc.date.accessioned2019-09-09T11:58:44Z
dc.date.available2019-09-09T11:58:44Z
dc.date.issued2018-08-06
dc.description.abstractBackground: 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.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid794en
dc.identifier.citationRedmond, 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-xen
dc.identifier.doi10.1186/s12885-018-4641-xen
dc.identifier.endpage8en
dc.identifier.issn1471-2407
dc.identifier.issued1en
dc.identifier.journaltitleBMC Canceren
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/8486
dc.identifier.volume18en
dc.language.isoenen
dc.publisherBioMed Central Ltd.en
dc.relation.urihttps://doi.org/10.1186/s12885-018-4641-x
dc.rights© 2018 The Author(s)en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectInflammationen
dc.subjectColon canceren
dc.subjectPeri-operativeen
dc.subjectMetastasisen
dc.subjectRecurrenceen
dc.titleRandomiSed 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. trialen
dc.typeArticle (peer-reviewed)en
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
s12885-018-4641-x.pdf
Size:
866.58 KB
Format:
Adobe Portable Document Format
Description:
Published version
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Biochemistry and Cell Biology - Journal Articles