Shah A, MacDonald W, Goldie J, Gudauskas G, Brisebois B
Cancer Treat Rep. 1985 Jul-Aug;69(7-8):739-42.
Ninety-four patients with advanced colorectal adenocarcinoma were treated by continuous iv 5-FU infusion on three different dose schedules. Thirty-three patients received a 72-hour infusion of 5-FU (30 mg/kg/24 hours) every 3 weeks (Group A); 31 received a 72-hour infusion of 5-FU (30 mg/kg/24 hours) every 2 weeks (Group B); and 30 received a 48-hour infusion of 5-FU (30 mg/kg/24 hours) every week (Group C). Although this was a sequential nonrandomized study of the dose schedules, the groups were comparable with respect to various prognostic factors. Response rates were as follows: Group A--three patients had minor response (9%) and 30 had no response (91%); Group B--five patients achieved partial response (16%), nine had minor response (29%), and 17 had no response (55%), and Group C--one patient achieved complete response (3%), eight achieved partial response (27%), five had minor response (17%), and 16 had no response (53%). The median survival time for Group A was 9 months, for Group B was 9.5 months, and for Group C was 14 months. Intensifying the dose schedule of 5-FU by increasing the frequency of administration has significantly improved response rates. A prolongation of the median survival time of patients treated with a 48-hour infusion at 1-week intervals was noted, although this was not statistically significant.
94例晚期结直肠癌患者接受了三种不同剂量方案的5-氟尿嘧啶(5-FU)持续静脉输注治疗。33例患者每3周接受一次72小时的5-FU输注(30mg/kg/24小时)(A组);31例患者每2周接受一次72小时的5-FU输注(30mg/kg/24小时)(B组);30例患者每周接受一次48小时的5-FU输注(30mg/kg/24小时)(C组)。尽管这是一项关于剂量方案的序贯非随机研究,但各组在各种预后因素方面具有可比性。缓解率如下:A组——3例患者有轻微缓解(9%),30例无缓解(91%);B组——5例患者达到部分缓解(16%),9例有轻微缓解(29%),17例无缓解(55%);C组——1例患者达到完全缓解(3%),8例达到部分缓解(27%),5例有轻微缓解(17%),16例无缓解(53%)。A组的中位生存时间为9个月,B组为9.5个月,C组为14个月。通过增加给药频率来强化5-FU的剂量方案显著提高了缓解率。虽然未达到统计学显著性,但观察到以1周间隔进行48小时输注治疗的患者中位生存时间有所延长。