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用具有里程碑意义的随机对照试验对近期全国直肠癌治疗实践进行基准测试。

Benchmarking recent national practice in rectal cancer treatment with landmark randomized controlled trials.

机构信息

Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

Colorectal Dis. 2017 Jun;19(6):O219-O231. doi: 10.1111/codi.13644.

Abstract

AIM

A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark.

METHOD

In this collaborative research project, the dataset of the Dutch Surgical Colorectal Audit was extended with additional treatment and long-term outcome data. All registered patients who underwent resection for rectal cancer in 2011 were eligible. Baseline characteristics and outcome were evaluated against the results of the Dutch TME trial and the COLOR II trial from which the original datasets were obtained.

RESULTS

A total of 71 hospitals participated, and data were completed for 2102 out of the potential 2633 patients (79.8%). Median follow-up was 41 (interquartile range 25-47) months. Overall circumferential resection margin (CRM) involvement was 9.3% in the Snapshot cohort and 18.5% in the Dutch TME trial. CRM positivity after laparoscopic resection was 7.8% in the Snapshot and 9.5% in the COLOR II trial. Three-year overall local recurrence rate in the Snapshot was 5.9%, with a disease-free survival of 67.1% and overall survival of 79.5%. Benchmarking with the randomized controlled trials revealed an overall favourable long-term outcome of the Snapshot cohort.

CONCLUSION

This study showed that current rectal cancer care in a large unselected Dutch population is of high quality, with less positive CRM since the TME trial and oncologically safe implementation of minimally invasive surgery after the COLOR II trial.

摘要

目的

快照研究设计消除了治疗和结果随时间的变化。这项基于人群的快照研究旨在以已发表的具有里程碑意义的随机对照试验为基准,确定直肠癌治疗的当前实践和结果。

方法

在这个合作研究项目中,荷兰外科结直肠癌审计数据集扩展了额外的治疗和长期结果数据。所有在2011年接受直肠癌切除术的登记患者均符合条件。根据荷兰全直肠系膜切除术(TME)试验和COLOR II试验的结果对基线特征和结果进行评估,原始数据集即来自这两项试验。

结果

共有71家医院参与,在2633名潜在患者中,2102名患者(79.8%)的数据完整。中位随访时间为41(四分位间距25 - 47)个月。在快照队列中,总的环周切缘(CRM)受累率为9.3%,在荷兰TME试验中为18.5%。腹腔镜切除术后CRM阳性率在快照队列中为7.8%,在COLOR II试验中为9.5%。快照队列中的三年总体局部复发率为5.9%,无病生存率为67.1%,总生存率为79.5%。与随机对照试验进行对比显示,快照队列的长期结果总体良好。

结论

这项研究表明,在未经过选择的大量荷兰人群中,当前的直肠癌治疗质量很高,自TME试验以来CRM阳性情况减少,且在COLOR II试验后微创外科手术在肿瘤学上安全实施。

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