Iwagaki H, Tanaka N, Esato K, Kaibara N, Sano K, Dohi K, Nakamura T, Nakasato H, Orita K
Department of Surgery I, Okayama University Medical School, 2-5-1 Shikatacho, Okayama 700-8448, Japan.
Anticancer Res. 2000 Sep-Oct;20(5C):3727-34.
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.
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.
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.
Inductive therapy with 5-FU in combination with oral HCFU is beneficial as adjuvant chemotherapy for advanced colorectal cancer with lymph node metastasis.
尽管手术可切除性是一个重要的预后因素，但晚期结直肠癌患者即使接受了看似根治性的手术，仍常出现复发。由于这种复发无法治愈，因此迫切需要更好的辅助化疗。
我们研究了1-己基氨基甲酰基-5-氟尿嘧啶（HCFU）口服联合或不联合5-氟尿嘧啶（5-FU）输注用于II期和III期结直肠癌根治性切除术后化疗的效果。本研究为前瞻性随机对照研究，316例患者中有303例（95.6%）被确定为统计评估对象。A组术后2周开始口服HCFU，每日300mg，共52周。B组术后第0天和第6天开始连续72小时静脉注射5-FU，剂量为333mg/m²体表面积/24小时。
A组和B组的5年总生存率和无病生存率无差异。B组5年无病生存率（47.6%）优于A组（42.9%）（p = 0.062），且淋巴结转移患者从手术到复发的间隔时间显著延长（p = 0.003）。相比之下，B组无淋巴结转移患者的5年无病生存率显著缩短（p = 0.010），复发率增加。
5-FU联合口服HCFU的诱导治疗作为晚期结直肠癌伴淋巴结转移的辅助化疗是有益的。
