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

BACKGROUND

Although surgical resectability is an important prognostic factor, 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 METHODS

We studied the effect of postoperative chemotherapy using 1-hexylcarbamoyl-5-fluorouracil (HCFU) oral administration with or without 5-fluorouracil (5-FU) infusion for curatively resected Stage II and III colorectal cancer. This study was prospectively randomized and controlled and 303 (95.6%) of 316 patients were determined to be candidates for statistical assessment. 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 postoperative day 0 and 6.

RESULTS

There were no differences in overall 5-year survival 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 significantly prolonged interval from surgery to recurrence (p = 0.003) for patients with lymph node metastasis. In contrast, group B had significantly shortened 5-year disease-free survival (p = 0.010) and increased recurrence rate in patients without lymph node metastasis.

CONCLUSION

Inductive therapy with 5-FU in combination with oral HCFU is beneficial as adjuvant chemotherapy for advanced colorectal cancer with lymph node metastasis.