A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent
A randomised controlled trial to assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent
复制标题
DOI：
10.3310/hta21320
复制
发表时间：
2017-05-01
影响因子：
3.6
通讯作者：
Primrose, John
中科院分区：
文献类型：
--
作者：
Mant, David;Gray, Alastair;Primrose, John
背景：结直肠癌术后强化随访是一种常见的做法，但缺乏确凿的证据基础。目的：评价在初级保健中采用两种强化随访方法[监测血癌胚抗原(CEA)水平和定期成像]来加强对症状性随访在检测可通过手术治疗的结直肠癌复发方面是否有效且成本效益高。设计：随机对照开放标签试验。参与者被随机分配到四组中的一组：(1)最少随访(n=301)，(2)仅CEA检测(n=300)，(3)仅计算机断层扫描(n=299)或(4)CEA检测+CT(n=302)。连续2年每3个月测定一次血CEA，连续3年每6个月测定一次CEA；连续2年每6个月行一次胸部、腹部和骨盆CT扫描，连续3年每年复查一次。那些接受最小剂量和仅接受CEA检测的患者在12-18个月时接受了一次CT扫描。这些组在辅助化疗、性别和年龄组(三个层次)方面被最小化。地点：英格兰的39家NHS医院，这些医院可以获得高容量的服务，提供转移复发的手术治疗。参与者：总共1202名参与者，他们接受了Dukes的A到C期结直肠癌的根治治疗，没有残留疾病。如有适应症，辅助治疗已完成。在轴位影像上没有转移的证据，术后血CEA水平是
Background: Intensive follow-up after surgery for colorectal cancer is common practice but lacks a firm evidence base.Objective: To assess whether or not augmenting symptomatic follow-up in primary care with two intensive methods of follow-up [monitoring of blood carcinoembryonic antigen (CEA) levels and scheduled imaging] is effective and cost-effective in detecting the recurrence of colorectal cancer treatable surgically with curative intent.Design: Randomised controlled open-label trial. Participants were randomly assigned to one of four groups: (1) minimum follow-up (n = 301), (2) CEA testing only (n = 300), (3) computerised tomography (CT) only (n = 299) or (4) CEA testing and CT (n = 302). Blood CEA was measured every 3 months for 2 years and then every 6 months for 3 years; CT scans of the chest, abdomen and pelvis were performed every 6 months for 2 years and then annually for 3 years. Those in the minimum and CEA testing-only arms had a single CT scan at 12-18 months. The groups were minimised on adjuvant chemotherapy, gender and age group (three strata).Setting: Thirty-nine NHS hospitals in England with access to high-volume services offering surgical treatment of metastatic recurrence.Participants: A total of 1202 participants who had undergone curative treatment for Dukes' stage A to C colorectal cancer with no residual disease. Adjuvant treatment was completed if indicated. There was no evidence of metastatic disease on axial imaging and the post-operative blood CEA level was