Postoperative adjuvant chemotherapy with 1-hexylcarbamoyl-5-fluorouracil in patients with colorectal cancer and at a high risk for recurrence

We examined the effects of postoperative 5-fluorouracil (5-FU) infusions an d oral treatment with 1-hexylcarbamoyl-5-fluorouarcil (HCFU) on patients cu ratively respected for stages II-IV colorectal cancer. The study was prospe ctively randomized, and 251 (93.3%) of 269 patients were valid candidates f or statistical assessment. The inductive regimen for group A included 5-FU 1- mg intravenous (iv) injections on days 0, 1, 2, 7, 8 and 9, postoperativ ely. For maintenance therapy, group A received HCFU 300 mg orally and daily for 52 weeks beginning 2 weeks after surgery. The regimen for group B incl uded only 5-FU injections. The effects of this chemotherapy were also retro spectively analyzed for groups at a high risk for recurrence, stages III-IV , transmural invasion-positive and lymph node metastasis-positive cases. Th ere was no statistical difference in survival time between the groups for 2 51 eligible cases (p = 0.079). In group A given 5-FU plus HCFU, there was a reduction in the recurrence rate for patients with stages III-IV or lymph node metastasis-positive colorectal cancers (p < 0.05) and prolongation of the survival time for patients with stage III-IV, transmural invasion-posit ive or lymph node-positive colorectal cancers (p < 0.05). Our findings show that the combination of 5-FU infusion and the continuous administration of HCFU is effective in treating patients with surgically resected colorectal cancer who are at high risk for a recurrence.