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Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial.

Braumann C, Gutt CN, Scheele J, Menenakos C, Willems W, Mueller JM, Jacobi CA - World J Surg Oncol (2009)

Bottom Line: The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear.Perioperative complications did not differ.Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Universitaetsmedizin Berlin, Charité Campus Mitte, Humboldt University, Charitéplatz 1, 10117 Berlin, Germany. chris.braumann@charite.de

ABSTRACT

Background: The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe.

Methods: In the settings of a multicentre (three University Hospitals) prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD) or 0.25% povidone-iodine (control) intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages) is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall) level of IL-1beta in peritoneal fluid.

Results: Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36), the cancer-related death rate (17 vs. 19, p = .2), the local recurrence rate (7 vs. 12, p = .16), the distant metastasis rate (13 vs. 18, p = 0.2) as well as the time to relapse were not statistically significant different.

Conclusion: Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection.

Trial registration: ISRCTN66478538.

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Trial profile.
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Figure 2: Trial profile.

Mentions: From the 158 patients assessed for eligibility for the study, 38 were excluded. Patients enrolled in the study included for TRD: Berlin n = 25, Frankfurt n = 18, Jena n = 17, and for povidone-iodine: Berlin n = 24, Frankfurt n = 18, and Jena n = 18. Figure 2 shows the trial profile. 120 patients took part in the study, with 60 patients in each group. The first operation was performed in February 2001 (follow-up 72 months) and the last organ resection was performed in August 2003 (42 months), so that the follow-up for all patients was at the end of 2007. The data were interpreted and the statistical analysis was performed in 2008. Detailed characteristics of patients including demographic profiles, ASA classification, co-morbidities, and the type of operation performed did not differ between the groups and are listed in Table 1. Types and sites of disease including the Union International Contre Le Cancer classifications (UICC) are also listed in Table 1.


Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial.

Braumann C, Gutt CN, Scheele J, Menenakos C, Willems W, Mueller JM, Jacobi CA - World J Surg Oncol (2009)

Trial profile.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2667516&req=5

Figure 2: Trial profile.
Mentions: From the 158 patients assessed for eligibility for the study, 38 were excluded. Patients enrolled in the study included for TRD: Berlin n = 25, Frankfurt n = 18, Jena n = 17, and for povidone-iodine: Berlin n = 24, Frankfurt n = 18, and Jena n = 18. Figure 2 shows the trial profile. 120 patients took part in the study, with 60 patients in each group. The first operation was performed in February 2001 (follow-up 72 months) and the last organ resection was performed in August 2003 (42 months), so that the follow-up for all patients was at the end of 2007. The data were interpreted and the statistical analysis was performed in 2008. Detailed characteristics of patients including demographic profiles, ASA classification, co-morbidities, and the type of operation performed did not differ between the groups and are listed in Table 1. Types and sites of disease including the Union International Contre Le Cancer classifications (UICC) are also listed in Table 1.

Bottom Line: The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear.Perioperative complications did not differ.Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Universitaetsmedizin Berlin, Charité Campus Mitte, Humboldt University, Charitéplatz 1, 10117 Berlin, Germany. chris.braumann@charite.de

ABSTRACT

Background: The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe.

Methods: In the settings of a multicentre (three University Hospitals) prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD) or 0.25% povidone-iodine (control) intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages) is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall) level of IL-1beta in peritoneal fluid.

Results: Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36), the cancer-related death rate (17 vs. 19, p = .2), the local recurrence rate (7 vs. 12, p = .16), the distant metastasis rate (13 vs. 18, p = 0.2) as well as the time to relapse were not statistically significant different.

Conclusion: Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection.

Trial registration: ISRCTN66478538.

Show MeSH
Related in: MedlinePlus