[Multicenter comparative study of the recurrence-inhibitory effect of oral fluoropyrimidine drugs in patients with colorectal cancer following curative resection].

HCFU and UFT were reported effective in adjuvant chemotherapy for colorectal cancer. This investigation was planned as a randomized study to compare the usefulness of combination therapies with mitomycin C (MMC)+HCFU and MMC+UFT as postoperative adjuvant chemotherapy in patients with colorectal cancer following curative resection, in terms of survival rate, recurrence rate, and adverse drug reactions. A total of 501 patients consisting of 252 patients with stage III/IV colon cancer (Colorectal Cancer Handling Rules, 4th Ed.) for which macroscopic curative resection was possible and 249 patients with stage II/III/IV rectal cancer (ibid, 4th Ed.) were registered from 40 participating institutions. The patients were randomly allocated to two groups with colon cancer and rectal cancer employed as stratification factors. Beginning on Day 14 after surgery, HCFU at 300 mg/day was administered to one group and UFT at 300 mg/day or 400 mg/day to another group, both orally and daily for one year. MMC 6 mg/m2 was administered intravenously to both groups on the day of surgery and the day following. Among the 501 patients, 496 patients (99%) were eligible. The 5-year survival rates were 77.1% for the MMC+ HCFU group and 79.2% for the MMC+UFT group, with the 5-year recurrence-free survival rates were 76.1% and 72.9%, respectively, neither showing a significant difference between the groups. Adverse drug reactions appeared in 23% of patients in the MMC+HCFU group and in 19% in the MMC+UFT group, with no serious reactions. One year after surgery the administration completion rates were good, at 82% for the MMC+HCFU group and 83% for the MMC+UFT group. No clear difference in effectiveness was noted between MMC+HCFU therapy and MMC+UFT therapy as postoperative adjuvant chemotherapy for colorectal cancer. The administration completion rates were good, and no serious adverse drug reactions were observed for either therapy. It was thus considered that both therapies could be administered safely, and both were useful as postoperative adjuvant chemotherapies for colorectal cancer. It is considered necessary to compare them with standard therapies in Western countries in the future.

Adjuvant hepatic arterial infusion chemotherapy after curative resection for Dukes C colorectal cancer: a pilot study.

BACKGROUND/AIMS: The aim of this study was to evaluate the effect and the toxicity of prophylactic adjuvant hepatic arterial infusion chemotherapy (HAIC) on liver metastases and on overall survival of Dukes C colorectal cancer patients. METHODOLOGY: Ninety patients in whom Dukes C colorectal cancer was diagnosed and were treated with curative resection between 1993 and 1997 underwent HAIC. The HAIC regimen consisted of a 24-hour continuous infusion of 1500 mg of 5-fluorouracil, administered once a week for 8 weeks, utilizing a portable infusion drug delivery system to ambulatory patients. Patients to whom 7 g or more of 5-fluorouracil could be given were included in the HAIC group, which resulted in 70 of the 90 patients being in this group. The HAIC group overall survival and liver recurrence rates were compared with those of 62 non-treated cases of Dukes C, which formed the non-HAIC control group. RESULTS: There were no serious toxic effects in this study. Significant differences were seen in the cumulative overall 5-year survival (HAIC group, 84.1%; non-HAIC group, 65.2%; p=0.0369). The cumulative 5-year liver metastasis-free rate was 92.7% in the HAIC group and 78.6% in the non-HAIC group (p=0.0649). In cases of distal lymph node metastasis, a risk factor for liver metastasis, the cumulative 5-year liver metastasis-free rate in the HAIC group (91.7%) was significantly higher than that in the non-HAIC group (58.6%; p=0.0268). CONCLUSIONS: HAIC effectively prevents metachronous liver metastasis, especially in patients with pre-existing distal lymph node metastases, and improves the prognosis of advanced colorectal cancer.