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
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 contr...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-08-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-018-4641-x |
| _version_ | 1830519056500785152 |
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| author | H. Paul Redmond Peter M. Neary Marcel Jinih Emer O’Connell Niamh Foley Rolf W. Pfirrmann Jiang H. Wang D. Peter O’Leary |
| author_facet | H. Paul Redmond Peter M. Neary Marcel Jinih Emer O’Connell Niamh Foley Rolf W. Pfirrmann Jiang H. Wang D. Peter O’Leary |
| author_sort | H. Paul Redmond |
| collection | DOAJ |
| 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). |
| first_indexed | 2024-12-22T04:29:27Z |
| format | Article |
| id | doaj.art-73b51778be3e4524bc2b216a3fbf5eb4 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-22T04:29:27Z |
| publishDate | 2018-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-73b51778be3e4524bc2b216a3fbf5eb42022-12-21T18:39:05ZengBMCBMC Cancer1471-24072018-08-011811810.1186/s12885-018-4641-xRandomiSed 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. trialH. Paul Redmond0Peter M. Neary1Marcel Jinih2Emer O’Connell3Niamh Foley4Rolf W. Pfirrmann5Jiang H. Wang6D. Peter O’Leary7Surguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalSurguvant Research Centre, Cork University HospitalAbstract 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).http://link.springer.com/article/10.1186/s12885-018-4641-xInflammationColon cancerPeri-operativeMetastasisRecurrence |
| spellingShingle | H. Paul Redmond Peter M. Neary Marcel Jinih Emer O’Connell Niamh Foley Rolf W. Pfirrmann Jiang H. Wang D. Peter O’Leary 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 BMC Cancer Inflammation Colon cancer Peri-operative Metastasis Recurrence |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Inflammation Colon cancer Peri-operative Metastasis Recurrence |
| url | http://link.springer.com/article/10.1186/s12885-018-4641-x |
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