Adjuvant therapy with hepatic irradiation plus fluorouracil in colon carcinoma. The Gastrointestinal Tumor Study Group

Abstract

In an attempt to reduce disease recurrence after curative resection of transmural or node positive colon cancer, the Gastrointestinal Tumor Study Group performed a randomized trial of observation versus 5-FU plus 2100 cGy to the liver. A total of 300 eligible trial participants form the basis of this report. Significant toxicity after the combination caused major dose reduction from the original course of 500 mg/m2 to 350 mg/m2. No therapeutic benefits were noted in either survival or recurrence endpoints; the liver recurrence rate was not decreased by the therapy. Analysis of patients with transmural colonic involvement and negative nodes, one to four positive, and greater than four positive nodes indicates that not all patients are alike with respect to disease outcome or overall survival, and that node number is an important determinant of patient selection for adjuvant trials.