Nakamura T, Ohno M, Tabuchi Y, Kamigaki T, Fujii H, Yamagishi H, Kuroda Y
First Department of Surgery, Kobe University School of Medicine, 7-5-2 Kusunkoki-cho, Chuo-ku, Kobe 650-0017, Japan.
Int J Oncol. 2001 Aug;19(2):291-8.
A multi-institutional study was performed to evaluate the appropriate duration of oral administration of Carmofur (1-hexylcarbamoyl-5-fluorouracil, HCFU), a 5-fluorouracil (5-FU) derivative, for postoperative adjuvant chemotherapy in patients with colorectal cancer undergoing curative operation. Patients were divided into two: i) short duration group receiving 6 months of HCFU administration and ii) long duration group receiving 1 year of the administration, using a centralized registration system. Among 364 patients entered in this study, 293 evaluable cases were analyzed to investigate the appropriate duration of adjuvant oral chemotherapy. No statistical differences were found in the cumulative 5-year disease-free or survival rates between the groups. However, the actual duration of oral HCFU administration differed in the patients of short and long duration groups from the protocol. Namely, more than 70% of the patients received a different duration of oral adjuvant chemotherapy in each of the groups. Therefore, apart from this division of two groups, correlation between the actual duration of oral HCFU administration and the prognosis was examined in these patients. As a result, it was suggested that oral adjuvant chemotherapy with HCFU would be effective in colon cancer patients when the duration of administration exceeded 330 days. In rectal cancer patients, however, adjuvant chemotherapy with HCFU alone was considered to be not sufficient to affect the prognosis.
开展了一项多机构研究，以评估5-氟尿嘧啶（5-FU）衍生物卡莫氟（1-己基氨基甲酰基-5-氟尿嘧啶，HCFU）口服给药用于接受根治性手术的结直肠癌患者术后辅助化疗的合适疗程。采用集中登记系统将患者分为两组：i）接受6个月HCFU给药的短疗程组和ii）接受1年给药的长疗程组。在本研究纳入的364例患者中，对293例可评估病例进行分析，以研究辅助口服化疗的合适疗程。两组之间的累积5年无病生存率或总生存率未发现统计学差异。然而，短疗程组和长疗程组患者的HCFU口服实际给药疗程与方案不同。也就是说，每组中超过70%的患者接受了不同疗程的口服辅助化疗。因此，除了这两组划分外，还对这些患者HCFU口服实际给药疗程与预后之间的相关性进行了研究。结果表明，当给药疗程超过330天时，HCFU口服辅助化疗对结肠癌患者有效。然而，在直肠癌患者中，单独使用HCFU辅助化疗被认为不足以影响预后。
