Monoclonal antibody therapy for resected Dukes' C colorectal cancer:: Seven-year outcome of a multicenter randomized trial
Monoclonal antibody therapy for resected Dukes' C colorectal cancer:: Seven-year outcome of a multicenter randomized trial
复制标题
DOI：
10.1200/jco.1998.16.5.1788
复制
发表时间：
1998-05-01
影响因子：
45.3
通讯作者：
Pichlmayr, R
中科院分区：
文献类型：
--
作者：
Riethmüller, G;Holz, E;Pichlmayr, R
目的：如前所述，抗体治疗增加了切除的Dukes' C期结直肠癌患者的存活率。由于5年分析因范围广泛而受到批评，（2.7至7.5年）的随访时间，我们进行了7年的分析，189例患者中只有4例监测不到5年。患者和方法：将总共189名切除Dukes' C结肠直肠癌的患者随机分配至总共900 mg 17-1A抗体的输注，术后500 mg，随后每月100 mg给药4次（n = 99），或仅观察（n = 90）。主要终点为总生存期和无病期。根据中心，性别，肿瘤的位置，受影响的淋巴结的数量，术前癌胚抗原concentration.Results：随机化产生的危险因素的平衡分布的动态随机化对患者进行分层。经过7年的随访vp评估，治疗使总死亡率降低了32%（考克斯比例风险，P <0.01;对数秩，P = 0.01），复发率降低了23%（考克斯比例风险，P <0.04;对数秩，P = 0.07）。意向治疗分析对总生存率（考克斯比例风险，P <0.01;对数秩，P = 0.02）和无病生存率（考克斯比例风险，P = 0.02;对数秩，P = 0.11）有显著影响。虽然远处转移显著减少（考克斯比例风险，P = 0.004;对数秩，P = 0.004），但局部复发没有减少（考克斯比例风险，P = 0.65;对数秩，P = 0.52）。17-1A抗体对分散的孤立的肿瘤细胞与隐匿性的本地卫星的这种差异效应可以解释增加的意义，看到在总survival.Conclusion：现在成熟的研究表明，17-1A抗体手术后管理，防止在大约三分之一的患者远处转移的发展。经7年随访评价，疗效维持。(C)1998年，美国临床肿瘤学会。
Purpose: As previously shown, antibody treatment increased survival of patients with resected colorectal cancer of stage Dukes' C. Since the 5-year analysis was criticized because of the wide range (2.7 to 7.5 years) of follow-up time, we performed a 7-year analysis with only four of 189 patients monitored for less than 5 years.Patients and Methods: A total of 189 patients with resected Dukes' C colorectal cancer were randomly allocated to infusions of a total of 900 mg 17-1A antibody, 500 mg postoperatively followed by 4 monthly doses of 100 mg (n = 99), or to observation only (n = 90). Primary end points were overall survival and disease-free interval. Patients were stratified by a dynamic randomization according to center, sex, location of tumor, number of affected lymph nodes, and preoperative carcinoembryonic antigen concentration.Results: Randomization produced balanced distribution of risk factors. After 7 years of follow-vp evaluation, treatment had reduced overall mortality by 32% (Cox's proportional hazard, P < .01; log-rank, P = .01) and decreased the recurrence rate by 23% (Cox's proportional hazard, P < .04; log-rank, P = .07). The intention-to-treat analysis gave a significant effect for overall survival (Cox's proportional hazard, P < .01; log-rank, P = .02) and disease-free survival (Cox's proportional hazard, P = .02; log-rank, P = .11). While distant metastases were significantly reduced (Cox's proportional hazard, P = .004; log-rank, P = .004), local relapses were not (Cox's proportional hazard, P = .65; log-rank, P = .52). This differential effect of 17-1A antibody on disseminated isolated tumor cells versus occult local satellites may explain the increased significance seen in the overall survival.Conclusion: The now-matured study shows that 17-1A antibody administered after surgery prevents the development of distant metastasis in approximately one third of patients. The therapeutic effect is maintained after 7 years of follow up evaluation. (C) 1998 by American Society of Clinical Oncology.