[Initial results of adjuvant portal liver infusion following radical surgery of colorectal cancer (Swiss Study Group for Epidemiologic and Clinical Cancer Research Study 40/81)]. / Erste Ergebnisse der adjuvanten portalen Leberinfusion nach Radikaloperation von Kolorektalkarzinomen (SAKK-Studie 40/81).

Between July 1981 and June 1987, 533 patients from 7 participating institutions have been entered in a prospective randomized trial to assess the value of adjuvant portal infusion (5-Fluorouracil 500 mg/m2/d x 7 continuous infusion + Mitomycin-C 10 mg/m2 on day 1 as a bolus injection through portal venous catheter) compared to radical surgery alone. The portal venous catheter was placed through any side-branch of the mesenteric venous system during laparotomy for the primary tumour. Using the transabdominal route, there have been no catheter-related complications. Overall hospital mortality in the study was 1.75% and was not influenced by adjuvant treatment. Analysis of 469 eligible patients at a median follow-up of 48 months revealed 39.1% recurrencies in the control group and 31.8% in the infusion group (p = 0.09, logrank). Median survival of control patients is 72 months, of chemotherapy treated patients not yet reached. Significant survival advantages have been detected for those 195 (85%) patients who received full-dose adjuvant chemotherapy (67% versus 53% 5-year survival). Due to the low number of deaths in this trial, prolonged follow-up is needed for definitive survival conclusions.