ASCO 2016:CREST试验——支架置入术改善梗阻性结直肠癌预后

2016-06-08 佚名 医脉通

2016年6月3-7日,一年一度的美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)年会在芝加哥举办。6月5日上午的消化系统(结直肠)肿瘤口头报告专场上,一项摘要号为3507的CREST试验(英国结直肠内镜下支架置入术试验),是一项在梗阻性结直肠癌中将支架置入术作为手术桥梁的随机III期研究,整理如下:在有可能治愈的梗阻性左半结直肠癌患者中

2016年6月3-7日,一年一度的美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)年会在芝加哥举办。6月5日上午的消化系统(结直肠)肿瘤口头报告专场上,一项摘要号为3507的CREST试验(英国结直肠内镜下支架置入术试验),是一项在梗阻性结直肠癌中将支架置入术作为手术桥梁的随机III期研究,整理如下:


在有可能治愈的梗阻性左半结直肠癌患者中,将腔内支架置入术作为一种紧急手术替代方式的疗效和安全性仍存在不确定性。紧急手术仍然占了所有结直肠癌病例的20%;梗阻性出现在80%的这些病例中。


因左半结肠梗阻就诊于急诊室的患者需要紧急减压术,根据癌症的影像学特征将患者随机分配接受:腔内支架置入术作为一种手术桥梁或者手术减压。以术前分期为基础根据治疗目的对患者进行分层。一种联合内镜/荧光技术在支架置入术联合选择性手术1-4周后开展是标准化的。


来自39个中心的246例患者在2009年到2014年之间被随机分组,98%的患者遵从分配的治疗。92%接受以治愈为目的的治疗。30天术后死亡率(5.3% vs 4.4%)和住院时间长度[15.5天(IQR 10-26)vs 16天(10-27)]在支架置入组和手术组是相似的。支架置入术在82%的患者中实现梗阻缓解,同时减轻吻合口形成;65%紧急手术 vs 45%支架置入术作为手术桥梁(P<0.001)。在3个月,12个月或者重症监护期间,QoL没有显著差异。可能治愈的患者1年死亡率根据治疗组不同而未有差异。


CReST是梗阻性结直肠癌腔内支架置入术的最大型试验。在身体状况足够接受手术的患者中,支架置入术作为手术的一种桥梁可以降低吻合口形成,同时对1年生存期不会产生不利影响。术后死亡率,住院时间,重症监护使用和生活质量在这两个治疗组之间不存在差异。临床试验信息:13846816。



原文摘要:


CREST: Randomised phase III study of stenting as a bridge to surgery in obstructing colorectal cancer—Results of the UK ColoRectal Endoscopic Stenting Trial (CREST).(Abstract3507)


Authors:James Hill, Clive Kay,et al


Session Type:Oral Abstract Session


Background: Uncertainty remains about the efficacy and safety of endoluminal stenting as an alternative to emergency surgery in patients with potentially curable obstructing left sided colorectal cancer. Emergency presentations still account for 20% of all colorectal cancer cases; obstruction is present in 80% of these. 


Methods: Patients presenting in the emergency setting with left-sided colonic obstruction needing urgent decompression and radiological features of a carcinoma were randomized to either: endoluminal stenting as a bridge to surgery or surgical decompression. Patients were stratified according to curative intent based on pre-operative staging investigations. A combined endoscopic/fluoroscopic technique was standardized in stent workshops with elective surgery performed 1-4 weeks later. 


Results: 246 patients from 39 units were randomized between 2009 and 2014 with 98% complying with allocated treatment. 92% were treated with curative intent. 30-day post-operative mortality (5.3% vs 4.4%) and length of hospital stay [15.5 days (IQR 10-26) vs 16 days (10-27)] were similar with stenting and surgery. Stenting achieved relief of obstruction in 82% of patients and reduced stoma formation; 69% emergency surgery v 45% with stenting as a bridge to surgery (p < 0.001). There were no significant differences in QoL at 3 and 12 months or critical care utilization. 1 year mortality for potentially curative patients did not differ by treatment group. 


Conclusions: CReST is the largest trial of endoluminal stenting in obstructing colorectal cancer. In patients fit enough to undergo surgery, stenting as a bridge to surgery reduced stoma formation without a detrimental effect on one-year survival. Post-operative mortality, length of hospital stay, critical care usage and Quality of Life were not different between the two treatment groups. Clinical trial information: 13846816.

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