Niimoto M, Kikuchi K, Kasai Y, Abe O, Kondo T, Taguchi T, Hattori T, Inokuchi K, Komi N, Ogawa N
Dept. of Surgery, Hiroshima University.
Gan To Kagaku Ryoho. 1988 Aug;15(8):2237-44.
To evaluate the efficacy of surgical adjuvant chemotherapy for patients with curatively resected colorectal cancer (excluding m and sm cancer), a randomized controlled study was performed from January 1982 to October 1983. The schedules for drug administration were different in four districts, and four randomly assigned protocols were studied using tegafur (FT), ACNU, MMC and ADM. A total of 4,906 cases from 491 institutions were entered and 4,206 cases were varied for the study. There were no significant differences in 3-year survival rate in each district protocol. According to Dukes C for rectal cancer patients, ADM + FT group was higher than the FT only group in 3-year survival rate (p = 0.092) and had a significantly longer survival than FT only group in 3-year disease-free rate (p = 0.011). The rate of local recidivation in colon cancer resected curatively was higher in ACNU + FT group than in FT only group (p less than 0.05). A tendency for decreased liver metastasis was observed in FT group compared with the control group, and liver metastasis of ADM + FT group was lower than that of FT only group. No serious adverse effects were observed in any protocol.
为评估手术辅助化疗对根治性切除的结直肠癌患者(不包括m期和sm期癌症)的疗效,于1982年1月至1983年10月进行了一项随机对照研究。四个地区的给药方案不同,使用替加氟(FT)、阿糖胞苷、丝裂霉素和阿霉素研究了四个随机分配的方案。来自491个机构的4906例患者入组,4206例患者纳入研究。各地区方案的3年生存率无显著差异。对于直肠癌患者,根据Dukes C分期,阿霉素+替加氟组的3年生存率高于单纯替加氟组(p = 0.092),3年无病生存率显著长于单纯替加氟组(p = 0.011)。根治性切除的结肠癌患者中,阿糖胞苷+替加氟组的局部复发率高于单纯替加氟组(p<0.05)。与对照组相比,替加氟组观察到肝转移有减少的趋势,阿霉素+替加氟组的肝转移低于单纯替加氟组。在任何方案中均未观察到严重不良反应。