Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Br J Surg. 2013 Jul;100(8):1100-7. doi: 10.1002/bjs.9166. Epub 2013 May 21.
Evaluating the external validity of clinical trials requires knowledge not only of the study population but also of a relevant reference population. The main aim of this study was to present data from a large, contemporary, population-based cohort of patients with colonic cancer.
Data on patients diagnosed between 2007 and 2011 were extracted from the Swedish Colon Cancer Registry. The data, registered prospectively in a national population of almost 10 million, included over 99 per cent of all diagnosed adenocarcinomas of the colon.
This analysis included 18,889 patients with 19,526 tumours (3·0 per cent had synchronous tumours). The sex distribution was fairly equal, and the median age was 74·1 (interquartile range 65-81) years. The overall and relative (cancer-specific) survival rates after 3 years were 62·7 and 71·4 per cent respectively. Some 88·0 per cent of the patients were operated on, and 83·8 per cent had tumours resected. Median blood loss during bowel resection was 200 (mean 311) ml, and the median operating time was 160 min; 5·6 per cent of the procedures were laparoscopic. Preoperative chemotherapy was administered to 2·1 per cent of patients; postoperative chemotherapy was planned in 90·1 per cent of fit patients aged less than 75 years with stage III disease. In patients operated on in an emergency setting (21·5 per cent), the preoperative evaluation was less extensive, the proportion of R0 resections was lower, and the outcomes were poorer, in both the short and long term.
These population-based data represent good-quality reference points.
评估临床试验的外部有效性不仅需要了解研究人群，还需要了解相关的参考人群。本研究的主要目的是提供来自大型、当代、基于人群的结肠直肠癌患者队列的数据。
从瑞典结肠癌登记处提取了 2007 年至 2011 年间诊断的患者数据。这些数据是在近 1000 万的全国人口中前瞻性登记的，包括 99%以上的所有诊断为结肠癌的腺癌。
本分析包括 18889 例患者和 19526 个肿瘤（3.0%有同步肿瘤）。性别分布相当均衡，中位年龄为 74.1（四分位距 65-81）岁。3 年后的总生存率和相对生存率（癌症特异性）分别为 62.7%和 71.4%。约 88.0%的患者接受了手术，83.8%的患者进行了肿瘤切除。肠切除术中的中位失血量为 200（平均 311）ml，中位手术时间为 160 分钟；5.6%的手术为腹腔镜手术。2.1%的患者接受了术前化疗；90.1%的年龄小于 75 岁且处于 III 期的适合手术的患者计划接受术后化疗。在紧急情况下接受手术的患者（21.5%）中，术前评估不够充分，R0 切除率较低，近期和长期预后均较差。
这些基于人群的数据代表了高质量的参考点。
