使用多靶点粪便DNA检测筛查结直肠癌:模拟检测间隔对临床有效性的影响

Screening for Colorectal Cancer Using a Multitarget Stool DNA Test: Modeling the Effect of the Intertest Interval on Clinical Effectiveness.

作者信息

Berger Barry M, Schroy Paul C, Dinh Tuan A

机构信息

Exact Sciences Corporation, Madison, WI.

Department of Gastroenterology, Boston University School of Medicine, Boston, MA.

出版信息

Clin Colorectal Cancer. 2016 Sep;15(3):e65-74. doi: 10.1016/j.clcc.2015.12.003. Epub 2015 Dec 18.

Abstract

BACKGROUND

A multitarget stool DNA (mt-sDNA) test was recently approved for colorectal cancer (CRC) screening for men and women, aged ≥ 50 years, at average risk of CRC. The guidelines currently recommend a 3-year interval for mt-sDNA testing in the absence of empirical data. We used clinical effectiveness modeling to project decreases in CRC incidence and related mortality associated with mt-sDNA screening to help inform interval setting.

MATERIALS AND METHODS

The Archimedes model (Archimedes Inc., San Francisco, CA) was used to conduct a 5-arm, virtual, clinical screening study of a population of 200,000 virtual individuals to compare the clinical effectiveness of mt-sDNA screening at 1-, 3-, and 5-year intervals compared with colonoscopy at 10-year intervals and no screening for a 30-year period. The study endpoints were the decrease in CRC incidence and related mortality of each strategy versus no screening. Cost-effectiveness ratios (US dollars per quality-adjusted life year [QALY]) of mt-sDNA intervals were calculated versus no screening.

RESULTS

Compared with 10-year colonoscopy, annual mt-sDNA testing produced similar reductions in CRC incidence (65% vs. 63%) and related mortality (73% vs. 72%). mt-sDNA testing at 3-year intervals reduced the CRC incidence by 57% and CRC mortality by 67%, and mt-sDNA testing at 5-year intervals reduced the CRC incidence by 52% and CRC mortality by 62%. At an average price of $600 per test, the annual, 3-year, and 5-year mt-sDNA screening costs would be $20,178, $11,313, and $7388 per QALY, respectively, compared with no screening.

CONCLUSION

These data suggest that screening every 3 years using a multitarget mt-sDNA test provides reasonable performance at acceptable cost.

摘要

背景

一种多靶点粪便DNA(mt-sDNA)检测最近被批准用于对年龄≥50岁、患结直肠癌(CRC)平均风险的男性和女性进行CRC筛查。目前的指南在缺乏经验数据的情况下建议mt-sDNA检测间隔为3年。我们使用临床有效性模型来预测与mt-sDNA筛查相关的CRC发病率和相关死亡率的下降情况,以帮助确定检测间隔。

材料与方法

使用阿基米德模型(阿基米德公司,加利福尼亚州旧金山)对200,000名虚拟个体组成的人群进行一项5组虚拟临床筛查研究,以比较1年、3年和5年间隔的mt-sDNA筛查与10年间隔的结肠镜检查以及30年不筛查的临床有效性。研究终点是每种策略与不筛查相比CRC发病率和相关死亡率的下降情况。计算了mt-sDNA不同间隔与不筛查相比的成本效益比(每质量调整生命年[QALY]的美元数)。

结果

与10年结肠镜检查相比,每年进行mt-sDNA检测在CRC发病率降低方面相似(65%对63%),在相关死亡率降低方面也相似(73%对72%)。3年间隔的mt-sDNA检测使CRC发病率降低57%,CRC死亡率降低67%;5年间隔的mt-sDNA检测使CRC发病率降低52%,CRC死亡率降低62%。每次检测平均价格为600美元时,与不筛查相比,每年、3年和5年的mt-sDNA筛查成本分别为每QALY 20,178美元、11,313美元和7388美元。

结论

这些数据表明,每3年使用多靶点mt-sDNA检测进行筛查能以可接受的成本提供合理的效果。

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