Terasawa T, Kousaki G, Sakai K, Senoo T, Taguchi T, Iwasa Z, Utsunomiya J, Okajima K, Okamoto E, Kawahara T
Dept. of Surgery, Center for Adult Diseases, Osaka.
Gan To Kagaku Ryoho. 1988 Jul;15(7):2073-80.
A prospective randomized study was performed in 22 institutions from July 1978, to evaluate the efficiency of long-term adjuvant chemotherapy with tegafur alone for primary breast cancer. Five hundred and eighty-seven eligible patients, classified into T1a, T2a, T3a, N0, N1a, N1b, and M0 were divided into two groups: Group A, radical mastectomy receiving no adjuvant chemotherapy; and Group B, radical mastectomy followed by 4 courses of adjuvant chemotherapy, each one consisting of daily administration of tegafur 600 mg p.o. for 8 weeks and 4 weeks rest. At the 66th month of median follow up time, there were no differences between the two groups on 5 year cumulative survival and disease free survival rate. In subgroup patients who have histologically 1-3 axillary involvements, there seemed to be a more meaningful prolongation of the disease-free interval in group B than in group A (logrank test; p = 0.11 generalized Wilcoxon test; p = 0.13).
1978年7月至1982年6月，在22个机构进行了一项前瞻性随机研究，以评估单独使用替加氟进行长期辅助化疗对原发性乳腺癌的疗效。587例符合条件的患者，分为T1a、T2a、T3a、N0、N1a、N1b和M0，分为两组：A组，接受根治性乳房切除术，不进行辅助化疗；B组，根治性乳房切除术后进行4个疗程的辅助化疗，每个疗程包括每天口服替加氟600mg，持续8周，休息4周。在中位随访时间的第66个月，两组在5年累积生存率和无病生存率方面没有差异。在组织学上有1-3个腋窝淋巴结受累的亚组患者中，B组的无病间期似乎比A组有更有意义的延长（对数秩检验；p=0.11；广义Wilcoxon检验；p=0.13）。
