Frey C, Twomey P, Keehn R, Elliott D, Higgins G
Cancer. 1981 Jan 1;47(1):27-31. doi: 10.1002/1097-0142(19810101)47:1<27::aid-cncr2820470106>3.0.co;2-f.
Between the years 1973-1977, 152 male patients from 28 participating Veterans Hospitals with histologically proven nonresectable cancer of the pancreas were randomized in a two-arm study. The treated group was to receive combination chemotherapy with 5-FU and CCNU, and the controls were to receive no chemotherapy. Both groups were comparable with respect to age, amount of weight loss, extent of histologically proved metastases, and operation performed. In the treatment group, drug therapy was begun between 10 and 60 days postoperatively. Intravenous 5-FU, 9 mg/kg, was administered on five consecutive days, and CCNU, 70 mg/m2, was given orally on the first day of each course. In the absence of toxicity, the course was repeated every six weeks for life; 146 drug courses were given. The incidence of toxicity was not great. One or more toxic reactions were reported for one-third of the drug courses administered, but for the most part, these were mild. The most frequent toxic reaction was vomiting in 17% of the courses, and hematologic toxicity-primarily leukopenia-in 15% of the drug courses. There was no evidence of a beneficial effect on survival from drug treatment in the group as a whole or in any subgroup analyzed. The median survival of the control group was 3.9 months, and of the drug-treated group, 3.0 months.
1973年至1977年间，来自28家参与研究的退伍军人医院的152名经组织学证实为不可切除胰腺癌的男性患者被随机分为两组进行研究。治疗组接受5-氟尿嘧啶（5-FU）和洛莫司汀（CCNU）联合化疗，对照组不接受化疗。两组在年龄、体重减轻程度、组织学证实的转移范围和所做的手术方面具有可比性。在治疗组中，药物治疗在术后10至60天开始。静脉注射5-FU，9毫克/千克，连续五天给药，CCNU，70毫克/平方米，在每个疗程的第一天口服。在没有毒性的情况下，该疗程每六周重复一次，直至生命结束；共进行了146个疗程的药物治疗。毒性发生率不高。在三分之一的给药疗程中报告了一种或多种毒性反应，但在大多数情况下，这些反应是轻微的。最常见的毒性反应是17%的疗程出现呕吐，15%的疗程出现血液学毒性——主要是白细胞减少。没有证据表明药物治疗对整个组或任何分析的亚组的生存有有益影响。对照组的中位生存期为3.9个月，药物治疗组为3.0个月。
