Sadahiro Sotaro, Mitomi Toshio, Noto Takashi, Kumada Kaoru, Hiki Yoshiki, Yamakawa Tatsuo, Amano Tomishige, Oki Shigeo, Otani Yoshimasa, Oka Hisashi, Takahashi Toshitake, Takemiya Shoji, Nishiyama Kiyoshi, Yamamura Takuya, Tsuchiya Shuji, Ogawa Nobuya
Dept. of Surgery, Tokai University School of Medicine.
Gan To Kagaku Ryoho. 2005 Jul;32(7):997-1005.
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.
据报道，替加氟脲（HCFU）和优福定（UFT）在结直肠癌辅助化疗中有效。本研究计划作为一项随机研究，比较丝裂霉素C（MMC）联合HCFU与MMC联合UFT作为根治性切除术后结直肠癌患者术后辅助化疗的有效性，包括生存率、复发率和药物不良反应。共有501例患者登记入组，其中包括252例III/IV期结肠癌患者（《结直肠癌诊疗规范（第4版）》），这些患者有可能进行宏观根治性切除；以及249例II/III/IV期直肠癌患者（同上，第4版），来自40个参与机构。患者被随机分为两组，以结肠癌和直肠癌作为分层因素。术后第14天开始，一组口服给予HCFU 300mg/天，另一组口服给予UFT 300mg/天或400mg/天，均每日给药，持续一年。两组在手术当天及术后第一天静脉给予MMC 6mg/m²。在501例患者中，496例（99%）符合条件。MMC+HCFU组的5年生存率为77.1%，MMC+UFT组为79.2%，5年无复发生存率分别为76.1%和72.9%，两组之间均无显著差异。MMC+HCFU组23%的患者出现药物不良反应，MMC+UFT组为19%，均无严重反应。术后一年给药完成率良好，MMC+HCFU组为82%，MMC+UFT组为83%。MMC+HCFU疗法与MMC+UFT疗法作为结直肠癌术后辅助化疗，在有效性方面未发现明显差异。给药完成率良好，两种疗法均未观察到严重的药物不良反应。因此，认为两种疗法均可安全给药，且均作为结直肠癌术后辅助化疗有效。认为未来有必要将它们与西方国家的标准疗法进行比较。
