Bentzen S M, Balslev I, Pedersen M, Teglbjaerg P S, Hanberg-Sørensen F, Bone J, Jacobsen N O, Sell A, Overgaard J, Bertelsen K
Danish Cancer Society, Department of Experimental Clinical Oncology, Aarhus C.
Br J Cancer. 1992 Jan;65(1):102-7. doi: 10.1038/bjc.1992.19.
Factors influencing time to loco-regional recurrence were identified in a multivariate regression analysis of data from a series of 468 radically operated patients (260 Dukes' B and 208 Dukes' C) with carcinoma of the rectum and the rectosigmoid. A number of clinical and pathological characteristics were prospectively collected and recorded. In addition, carcinoembryonic antigen (CEA) was measured within 1 week before surgery. The endpoint used was recurrence below the level of the umbilicus. All patients were followed for at least 5 years or until time of death. The two Dukes' stages B and C were analysed in two separate analyses using the Cox proportional hazards model. In patients with Dukes' B tumours, an increased risk of loco-regional recurrence was associated with perineural invasion, tumour located less than 10 cm from the anal verge, patient aged above 70 years, and small tumour size. In patients with Dukes' C tumours, the necessity to resect neighbour organs, perineural and venous invasion, tumour located less than 10 cm from the anal verge, and large tumour size were all associated with a poor loco-regional outcome. Postoperative radiotherapy was not a significant prognosticator for loco-regional control. An update of the 5-year results of the randomised study of post-operative radiotherapy (50 Gy with 2 Gy per fraction in an overall treatment time of 7 weeks) showed no survival benefit from adjuvant radiotherapy in either Dukes' category and no statistically significant improvement in the 5-year loco-regional control rate. However, when the comparison was restricted to a group of high-risk patients there was a statistically significant benefit from radiotherapy with respect to loco-regional control (P = 0.03) but not with respect to survival (P = 0.23). The potential advantage, in terms of the required number of patients, of restricting clinical trials of intensified loco-regional therapies to the high-risk patients, is illustrated.
在一项对468例接受根治性手术的直肠和直肠乙状结肠癌症患者（260例杜克B期和208例杜克C期）的数据进行的多变量回归分析中，确定了影响局部区域复发时间的因素。前瞻性收集并记录了一些临床和病理特征。此外，在手术前1周内测量癌胚抗原（CEA）。所使用的终点是脐水平以下的复发。所有患者均随访至少5年或直至死亡。使用Cox比例风险模型对杜克B期和C期这两个阶段分别进行分析。在杜克B期肿瘤患者中，局部区域复发风险增加与神经周围浸润、肿瘤距肛缘小于10 cm、年龄70岁以上的患者以及肿瘤体积小有关。在杜克C期肿瘤患者中，切除邻近器官的必要性、神经周围和静脉浸润、肿瘤距肛缘小于10 cm以及肿瘤体积大均与局部区域预后不良有关。术后放疗不是局部区域控制的显著预后因素。一项关于术后放疗（50 Gy，每次分割2 Gy，总治疗时间7周）的随机研究的5年结果更新显示，在任何一个杜克分期中，辅助放疗均无生存获益，5年局部区域控制率也无统计学显著改善。然而，当将比较限于一组高危患者时，放疗在局部区域控制方面有统计学显著获益（P = 0.03），但在生存方面无显著获益（P = 0.23）。说明了将强化局部区域治疗的临床试验限于高危患者在所需患者数量方面的潜在优势。
