ADJUVANT PORTAL-VEIN INFUSION OF FLUOROURACIL AND HEPARIN IN COLORECTAL-CANCER - A RANDOMIZED TRIAL

Background. There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentr e trial to investigate the efficacy of PVI (500 mg/m(2) fluorouracil p lus 5000 IU heparin daily for 7 days). Methods. 1235 of about 1500 pot entially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary e ndpoint was survival; analyses were by intention to treat. Findings. 6 19 patients in the control group and 616 in the PVI group met eligibil ity criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between t he groups (73 vs 72%; 95% CI for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 ye ars (67 vs 65%) and the number of patients with liver metastases (79 v s 77%). Interpretation. PVI of fluorouracil, at a dose of 500 mg/m(2) for 7 days, cannot be recommended as the sole adjuvant treatment for h igh-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a h igher dosage or in combination with mitomycin.