533 patients with diagnosis of operable colorectal carcinoma were rand
omized to receive either a single course of portal infusion with Mitom
ycin-C (MMC) and 5-Fluorouracil (5-FU) starting immediately after oper
ation, or no adjuvant treatment. Of these, 505 (94%) were evaluable. O
ver the median follow-up of 8 years, the adjuvant therapy reduced the
risk of recurrence by 22% (Hazard ratio = 0.78%, 95% CI 0.61-0.99; P =
0.045). The relative reduction of relapse on death was similar in all
subgroups (i. e. nodal status, localization). However, adjuvant porta
l chemotherapy proved to be most efficient in the subgroups of patient
s with tumor involvement of the regional lymph nodes (Dukes C) and of
patients with colon cancer. Analysis of the pattern of relapse showed
that most of the difference in overall and disease-free survival is to
be attributed to a consistent reduction of all kinds of tumor recurre
nces (i. e. local relapses, liver metastases and/or other distant meta
stases) in the treated group, rather than to liver relapses alone. We
conclude therefore, that part of significant benefit obtained for pati
ents with operable colorectal carcinoma treated with a single course o
f adjuvant chemotherapy via the portal vein might be due to the additi
onal systemic effects of the portal chemotherapy and further study of
perioperative treatment with and without prolonged chemotherapy appear
s worthwile.