Moertel C G, Fleming T R, Macdonald J S, Haller D G, Laurie J A, Tangen C M, Ungerleider J S, Emerson W A, Tormey D C, Glick J H, Veeder M H, Mailliard J A
Mayo Clinic, Rochester, Minnesota.
Ann Intern Med. 1995 Mar 1;122(5):321-6. doi: 10.7326/0003-4819-122-5-199503010-00001.
To determine the effectiveness of two adjuvant therapy regimens in improving surgical cure rates in stage III (Dukes stage C) colon cancer.
Randomized, concurrently controlled clinical trial.
Major cancer centers, universities, and community clinics affiliated with the North Cancer Treatment Group, the Southwest Oncology Group, and the Eastern Cooperative Oncology Group.
Those who had had curative-intent resections of stage III colon cancer in the previous 1 to 5 weeks.
Patients were assigned to observation only, to levamisole alone (50 mg orally three times/d for 3 days, repeated every 2 weeks for 1 year), or to this regimen of levamisole plus fluorouracil (450 mg/m2 body surface area intravenously daily for 5 days and then, beginning at 28 days, weekly for 48 weeks).
Rates of cancer recurrence and death. Early- and late-treatment side effects.
With all 929 eligible patients able to be followed for 5 years or more (median follow-up, 6.5 years), fluorouracil plus levamisole reduced the recurrence rate by 40% (P < 0.0001) and the death rate by 33% (P = 0.0007). Levamisole reduced the recurrence rate by only 2% and the death rate by only 6%. With few exceptions, toxicity was mild and patient compliance was excellent. No evidence of late side effects was seen.
Fluorouracil plus levamisole is tolerable adjuvant therapy to surgery; it has been confirmed to substantially increase cure rates for patients with high-risk (stage III) colon cancer. It should be considered standard treatment for all such patients not entered into clinical trials.
确定两种辅助治疗方案对提高Ⅲ期（杜克C期）结肠癌手术治愈率的有效性。
随机、同期对照临床试验。
与北癌症治疗组、西南肿瘤学组和东部肿瘤协作组相关的主要癌症中心、大学及社区诊所。
在过去1至5周内接受了Ⅲ期结肠癌根治性手术的患者。
患者被分配至仅观察、仅接受左旋咪唑（口服50毫克，每日3次，共3天，每2周重复一次，持续1年）或该左旋咪唑加氟尿嘧啶方案（450毫克/平方米体表面积，静脉注射，每日1次，共5天，然后从第28天开始，每周1次，持续48周）。
癌症复发率和死亡率。早期及晚期治疗副作用。
所有929名符合条件的患者均能随访5年或更长时间（中位随访时间为6.5年），氟尿嘧啶加左旋咪唑使复发率降低了40%（P<0.0001），死亡率降低了33%（P = 0.0007）。左旋咪唑仅使复发率降低了2%，死亡率仅降低了6%。除少数例外，毒性轻微，患者依从性良好。未观察到晚期副作用的证据。
氟尿嘧啶加左旋咪唑是可耐受的手术辅助治疗；已证实其可大幅提高高危（Ⅲ期）结肠癌患者的治愈率。对于所有未参加临床试验的此类患者，应考虑将其作为标准治疗。
