Clinical identification of colorectal cancer patients benefiting from adjuvant uracil-tegafur (UFT): a randomized controlled trial.

PURPOSE: A randomized controlled trial was conducted to determine whether pathologic necrosis in response to preoperative treatment with uracil-tegafur(UFT) could be used to identify patients with colorectal cancer most likely to benefit from postoperative adjuvant therapy with the drug. PATIENTS AND METHODS: The 152 patients with colorectal cancer who received preoperative UFT at a dose of 600 mg/day for at least 10 days were classified into two groups according to the pathologic necrosis in resected tumor specimens: 90% or more necrosis (sensitive) versus less than 90% necrosis (insensitive). After excluding 13 ineligible patients, the remaining 139 were then randomly assigned to receive postoperative adjuvant UFT (400 mg/day) for 12 months or no treatment.
RESULTS: Preoperative and postoperative UFT produced no serious toxicity in any of the patients. Among the 22 patients with sensitive tumors, overall survival was significantly better in the UFT group (n = 12) than in the control (n = 10) (100 vs. 70.0%; P = 0.023). Among the 117 patients with insensitive tumors, there was no significant difference between the two groups (n = 60, 68.1% vs. n = 57, 76.6%; P = 0.373).
CONCLUSION: Our method involving neoadjuvant UFT can identify patients most likely to benefit from postoperative UFT, as well as those unlikely to benefit from such treatment.

RCT Entities:   Population Interventions Outcomes