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MRC CLASICC 试验:结直肠癌开腹与腹腔镜辅助手术的长期随访。

Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer.

机构信息

Clinical Trials Research Unit, University of Leeds, and Sections of Molecular Medicine, St James's University Hospital, Leeds, UK.

出版信息

Br J Surg. 2013 Jan;100(1):75-82. doi: 10.1002/bjs.8945. Epub 2012 Nov 6.


DOI:10.1002/bjs.8945
PMID:23132548
Abstract

BACKGROUND: Laparoscopic resection is used widely in the management of colorectal cancer; however, the data on long-term outcomes, particularly those related to rectal cancer, are limited. The results of long-term follow-up of the UK Medical Research Council trial of laparoscopically assisted versus open surgery for colorectal cancer are presented. METHODS: A total of 794 patients from 27 UK centres were randomized to laparoscopic or open surgery in a 2:1 ratio between 1996 and 2002. Long-term follow-up data were analysed to determine differences in survival outcomes and recurrences for intention-to-treat and actual treatment groups. RESULTS: Median follow-up of all patients was 62·9 (interquartile range 22·9 - 92·8) months. There were no statistically significant differences between open and laparoscopic groups in overall survival (78·3 (95 per cent confidence interval (c.i.) 65·8 to 106·6) versus 82·7 (69·1 to 94·8) months respectively; P = 0·780) and disease-free survival (DFS) (89·5 (67·1 to 121·7) versus 77·0 (63·3 to 94·0) months; P = 0·589). In colonic cancer intraoperative conversions to open surgery were associated with worse overall survival (hazard ratio (HR) 2·28, 95 per cent c.i. 1·47 to 3·53; P < 0·001) and DFS (HR 2·20, 1·31 to 3·67; P = 0·007). In terms of recurrence, no significant differences were observed by randomized procedure. However, at 10 years, right colonic cancers showed an increased propensity for local recurrence compared with left colonic cancers: 14·7 versus 5·2 per cent (difference 9·5 (95 per cent c.i. 2·3 to 16·6) per cent; P = 0·019). CONCLUSION: Long-term results continue to support the use of laparoscopic surgery for both colonic and rectal cancer.

摘要

背景:腹腔镜切除术被广泛应用于结直肠癌的治疗中;然而,有关长期疗效的数据,尤其是直肠癌的相关数据,非常有限。本文报告了英国医学研究理事会(MRC)关于腹腔镜辅助与开腹手术治疗结直肠癌的临床试验的长期随访结果。

方法:1996 年至 2002 年期间,共有 794 名来自 27 个英国中心的患者被随机分配接受腹腔镜或开腹手术治疗,比例为 2:1。对所有患者进行了中位随访 62.9(25%分位数-92.8)个月。对意向治疗和实际治疗组的生存结果和复发数据进行了分析,以确定差异。

结果:所有患者的中位随访时间为 62.9(25%分位数-92.8)个月。开腹组和腹腔镜组之间在总生存(78.3(95%置信区间(CI)65.8 至 106.6)与 82.7(69.1 至 94.8)个月;P = 0.780)和无病生存(DFS)(89.5(67.1 至 121.7)与 77.0(63.3 至 94.0)个月;P = 0.589)方面无统计学差异。在结肠癌中,术中转为开腹手术与较差的总生存(风险比(HR)2.28,95%CI 1.47 至 3.53;P<0.001)和 DFS(HR 2.20,1.31 至 3.67;P = 0.007)相关。在复发方面,随机手术无显著差异。然而,在 10 年时,右半结肠癌的局部复发率高于左半结肠癌:14.7%比 5.2%(差异 9.5(95%CI 2.3 至 16.6)%;P = 0.019)。

结论:长期结果继续支持腹腔镜手术用于结直肠癌的治疗。

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