• Anticancer research · Nov 1998

    Randomized Controlled Trial Comparative Study Clinical Trial

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

    • Y Maehara, K Sugimachi, M Ogawa, T Kakegawa, M Tomita, and T Akiyoshi.
    • Department of Surgery II, Faculty of Medicine, Kyushu University, Fukuoka, Japan.
    • Anticancer Res. 1998 Nov 1; 18 (6B): 4629-34.

    AbstractWe examined the effects of postoperative 5-fluorouracil (5-FU) infusions and oral treatment with 1-hexylcarbamoyl-5-fluorouracil (HCFU) on patients curatively resected for stages II-IV colorectal cancer. The study was prospectively randomized, and 251 (93.3%) of 269 patients were valid candidates for statistical assessment. The inductive regimen for group A included 5-FU 10 mg intravenous (i.v.) injections on days 0, 1, 2, 7, 8 and 9, postoperatively. 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 included only 5-FU injections. The effects of this chemotherapy were also retrospectively analyzed for groups at a high risk for recurrence, stages III-IV, transmural invasion-positive and lymph node metastasis-positive cases. There was no statistical difference in survival time between the groups for 251 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-positive 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.

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