Department of Gastroenterology, Hospital Universitario de Canarias, Tenerife, Spain.
N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population.
In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations.
The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001).
Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.).
结肠镜检查和粪便免疫化学检测（FIT）是一般风险人群结直肠癌筛查的可接受策略。
在这项涉及无症状 50 至 69 岁成年人的随机对照试验中，我们将 26703 名受试者单次结肠镜检查与 26599 名受试者每 2 年进行一次 FIT 进行了比较。主要结局是 10 年时结直肠癌的死亡率。本中期报告描述了基线筛查完成时的参与率、诊断发现和主要并发症的发生情况。研究结果在意向筛查人群和实际筛查人群中进行了分析。
FIT 组的参与率高于结肠镜组（34.2%比 24.6%，P<0.001）。结肠镜组发现 30 例（0.1%）结直肠癌，FIT 组发现 33 例（0.1%）（比值比，0.99；95%置信区间[CI]，0.61 至 1.64；P=0.99）。结肠镜组发现 514 例（1.9%）高级腺瘤，FIT 组发现 231 例（0.9%）（比值比，2.30；95%CI，1.97 至 2.69；P<0.001），非高级腺瘤在结肠镜组发现 1109 例（4.2%），FIT 组发现 119 例（0.4%）（比值比，9.80；95%CI，8.10 至 11.85；P<0.001）。
FIT 组的受试者比结肠镜组更有可能参与筛查。在基线筛查检查中，两组中发现结直肠癌的受试者数量相似，但结肠镜组发现的腺瘤数量更多。（由西班牙卡洛斯三世健康研究所等资助；ClinicalTrials.gov 编号，NCT00906997。）
