Wunderlich M, Schiessel R, Rainer H, Rauhs R, Kovats E, Schemper M, Dittrich C, Micksche M, Sedlacek H H
Br J Surg. 1985 Sep;72 Suppl:S107-10. doi: 10.1002/bjs.1800721352.
After radical surgery for colorectal cancer, 178 patients with a Dukes' B or C tumour were randomly assigned to one of three groups: A, controls (n = 62); B, chemotherapy (n = 59); C, immunotherapy (n = 57). Randomization criteria (age, sex, Dukes' stage, localization of tumour, operative procedure) were evenly distributed throughout the groups. After a median observation time of 30 months, statistical analyses were performed: survival and probability to be free of recurrence was described by Kaplan-Meier estimates of the survival function; for comparison of these survival functions, Breslow's test was used. Overall analyses show no benefit in the treatment group compared to controls. Separate analyses by Dukes' stages showed that in patients with Dukes' C tumours the probability of survival 40 months after surgery was 72 per cent in group C, 51 per cent in group B, and 33 per cent in group A. The differences between groups C and A, and B and A were statistically significant (P less than 0.02 and P less than 0.03 respectively). For a Dukes' C tumour the probability to be free of distant metastases at 30 months after surgery was 80 per cent in group B, 68 per cent in group C and 52 per cent in group A. Also for a Dukes' C tumour the probability to be free of liver metastases at 21 months after surgery was 83 per cent in group B, 81 per cent in group C, and 54 per cent in group A (significant differences: B-A and C-A P less than 0.04 for both). There was no influence on the estimated incidence of local recurrences for stage Dukes' C. Patients with a Dukes' B tumour did not benefit from either of the adjuvant therapy schemes.
在接受结直肠癌根治性手术后，178例患有Dukes' B期或C期肿瘤的患者被随机分为三组：A组为对照组（n = 62）；B组为化疗组（n = 59）；C组为免疫治疗组（n = 57）。随机化标准（年龄、性别、Dukes'分期、肿瘤位置、手术方式）在各组间均匀分布。经过30个月的中位观察期后，进行了统计分析：生存情况和无复发概率通过生存函数的Kaplan-Meier估计值来描述；为比较这些生存函数，使用了Breslow检验。总体分析显示，与对照组相比，治疗组并无益处。按Dukes'分期进行的单独分析表明，对于患有Dukes' C期肿瘤的患者，术后40个月的生存率在C组为72%，B组为51%，A组为33%。C组与A组、B组与A组之间的差异具有统计学意义（分别为P < 0.02和P < 0.03）。对于Dukes' C期肿瘤，术后30个月无远处转移的概率在B组为80%，C组为68%，A组为52%。同样对于Dukes' C期肿瘤，术后21个月无肝转移的概率在B组为83%，C组为81%，A组为54%（显著差异：B - A和C - A，两者P均< 0.04）。对于Dukes' C期，局部复发的估计发生率没有受到影响。患有Dukes' B期肿瘤的患者未从任何一种辅助治疗方案中获益。
