Lawrence W, Terz J J, Horsley J S, Brown P W, Romero C
Arch Surg. 1978 Feb;113(2):164-8. doi: 10.1001/archsurg.1978.01370140054011.
An adjuvant program of fluorouracil for patients undergoing "curative" resection for adenocarcinoma of the colon and rectum was initiated as a randomized clinical trial in January 1968. Patients were randomly assigned to an intraluminal fluorouracil or intraluminal control (saline) group and were so treated at the time of surgical resection if findings at operation indicated that all gross neoplastic disease could be resected. Those patients receiving intraluminal fluorouracil (30 mg/kg) received intravenous fluorouracil (10 mg/kg) on each of the first two postoperative days and five subsequent postoperative courses of oral fluorouracil (90 mg/kg) in each 18-day course over a one-year period. By July 1, 1975, there were 203 patients undergoing curative resection entered into the study. Survival and disease-free data, as of Dec 31, 1976, revealed no benefit from this adjuvant course of fluorouracil. These data support the need for continued randomized clinical trials of new and innovative adjuvant therapy compared with an untreated control group.
1968年1月，一项针对接受结肠癌和直肠癌“根治性”切除术患者的氟尿嘧啶辅助治疗方案作为一项随机临床试验启动。患者被随机分配到腔内氟尿嘧啶组或腔内对照组（生理盐水组），如果手术结果表明所有肉眼可见的肿瘤性疾病都可以切除，则在手术切除时接受相应治疗。那些接受腔内氟尿嘧啶（30mg/kg）的患者在术后头两天每天接受静脉注射氟尿嘧啶（10mg/kg），并在随后的一年中，在每18天的疗程中接受五个术后口服氟尿嘧啶疗程（90mg/kg）。到1975年7月1日，有203例接受根治性切除术的患者进入该研究。截至1976年12月31日的生存和无病数据显示，这种氟尿嘧啶辅助疗程没有益处。这些数据支持了与未治疗的对照组相比，继续开展新的创新性辅助治疗随机临床试验的必要性。
