Randomized controlled trial of 5-fluorouracil (5-FU) infusion combined with 1-hexylcarbamoyl-5-fluorouracil (HCFU) oral administration and HCFU aloneas postoperative adjuvant chemotherapy for colorectal cancer

Background: Although surgical resectability is an important prognostic fact or, recurrences are commonly noted in advanced colorectal cancer patients, even after apparently curative surgery. Because such recurrences cannot be cured, better adjuvant chemotherapies are urgently required. Patients and M ethods: We studied the effect of postoperative chemotherapy using 1-hexylca rbamoyl-5-fluorouracil (HCFU) oral administration with ol without 5-fluorou racil (5-FU) infusion for curatively resected Stage II and III colorectal c ancer. This study was prospectively randomized and controlled and 303 (95.6 %) of 316 patients were determined to be candidates for statistical assessm ent. Group A received oral HCFU 300 mg daily for 52 weeks beginning 2 weeks after surgery. Group B also received 5-FU intravenous injection, 333 mg/m2 body surface area/24 hours continuously for 72 hours beginning on postoper ative day 0 and 6 Results: There were no differences in overall 5-year surv ival or disease-free survival between Groups A and B. Group B had better 5- year disease-free survival (47.6%) than Group A (42.9%) (p=0.062) and signi ficantly prolonged interval from surgery to recurrence (p=0.003) for patien ts with lymph node metastasis. In contrast, group B had significantly short ened 5-year disease-free survival (p=0.010) and increased recurrence rate i n patients without lymph node metastasis. Conclusion: Inductive therapy wit h 5-FU in combination with oral HCFU is beneficial as adjuvant chemotherapy for advanced colorectal cancer with lymph node metastasis.