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


CONCLUSIONS
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.


BACKGROUND
ISRCTN66478538.
Braumann
Chris
C
Department of General, Visceral, Vascular and Thoracic Surgery, Universitaetsmedizin Berlin, Charité Campus Mitte, Humboldt University, Charitéplatz 1, 10117 Berlin, Germany. chris.braumann@charite.de
Gutt
Carsten N
CN
Scheele
Johannes
J
Menenakos
Charalambos
C
Willems
Wilhelm
W
Mueller
Joachim M
JM
Jacobi
Christoph A
CA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000601:surgery; D006801:Humans; D053583:Interleukin-1beta / Q000032:analysis*; D015850:Interleukin-6 / Q000032:analysis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013654:Taurine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013829:Thiadiazines / Q000627:therapeutic use*
D053583:Interleukin-1beta; D015850:Interleukin-6; D013829:Thiadiazines; D013654:Taurine; C012566:taurolidine