This prospectively randomized clinical trial was carried out in four Dutch hospitals to reduce the development of metachronous liver metastases and to get a better survival in patients with colorectal malignancies after surgically radical en bloc resection of the primary tumor and the regional lymph nodes. Three hundred seventeen patients were randomized to participate in three trial arms. One group of patients was treated by surgery alone (control group); in the other patients a catheter was placed in the dilated umbilical vein and advanced until the tip was lying in the left branch of the portal vein. Fifty percent of these patients got immediate postoperative portal infusion with 1 g 5-flnorouracil (5-FU) and 5000 U heparin daily for 7 days; the others received portal vein infusion with urokinase 10.000 U/honr for 24 hours only. Three hundred four patients were eligible. Overall hospital mortality was 3.6% (11 patients) and was not influenced by adjuvant treatment. After a median follow-up of 44 months 66 patients have died with relapse and 21 as a result of other causes. The chance of developing liver metastases and other distant metastases after portal infusion with 5-FU/heparin was one third of the chance in the control group (P < 0.001). Only an insignificant reduction of the average death rate in the 5-FU/heparin group was found.In the urokinase group no significant effect in reducing metastases or in survival was noted. Before recommending cytotoxic portal infusion as an adjuvant treatment in patients with colorectal cancer, detailed analysis of other ongoing portal infusion studies has to be awaited and careful calculations have to be made regarding how many patients really can be saved by this treatment.Cancer 65425-432, 1990.N AUTOPSY STUDIES of patients who died from colo-I rectal cancer, liver metastases were found in about 50% to 80%.' At time of surgery up to 25% of patients with primary colorectal cancer already have macroscopic liver metastases2 The number of patients with microscopic metastases is unknown.Tumor invasion into mesenteric veins causes spread of The authors thank Mrs. Mirjam Linskens for help in data collection and preparation of the manuscript, and Mr. P. J. van Assendelft for assistance in data management and analysis. The authors also thank all of the patients who were willing to cooperate in this study and who had the patience to undergo the multiple sometimes unpleasant investigations.Address for reprints: Jack C. J. Wereldsma, MD, PhD, Department of Surgery, Sint Franciscus Gasthuis, Kleiweg 500,3045 PM Rotterdam, The Netherlands.Accepted for publication July 2 1, 1989.circulating malignant cells to the portal vein.3 These tumor cells surrounded by fibrin and platelets may form tumor clots which can adhere at the vascular endothelium of the liver capillaries. These microfoci can develop into macroscopic metastases initiated by, until now, unknown factors. This tumor cell embolus theory sounds reasonable, the unknown factors being the induction of anesthesia, operative stress...
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