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基于血液生物标志物的结直肠癌筛查:甲基化 Septin 9 DNA 与现行策略的成本效益比较。

Colorectal cancer screening with blood-based biomarkers: cost-effectiveness of methylated septin 9 DNA versus current strategies.

机构信息

Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305-5187, USA.

出版信息

Cancer Epidemiol Biomarkers Prev. 2013 Sep;22(9):1567-76. doi: 10.1158/1055-9965.EPI-13-0204. Epub 2013 Jun 24.

Abstract

BACKGROUND

Screening reduces colorectal cancer mortality, but many persons remain unscreened. Screening with a blood test could improve screening rates. We estimated the comparative effectiveness and cost-effectiveness of colorectal cancer screening with emerging biomarkers, illustrated by a methylated Septin 9 DNA plasma assay ((m)SEPT9), versus established strategies.

METHODS

We conducted a cost-utility analysis using a validated decision analytic model comparing (m)SEPT9, fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), sigmoidoscopy, and colonoscopy, projecting lifetime benefits and costs.

RESULTS

In the base case, (m)SEPT9 decreased colorectal cancer incidence by 35% to 41% and colorectal cancer mortality by 53% to 61% at costs of $8,400 to $11,500/quality-adjusted life year gained versus no screening. All established screening strategies were more effective than (m)SEPT9. FIT was cost saving, dominated (m)SEPT9, and was preferred among all the alternatives. Screening uptake and longitudinal adherence rates over time strongly influenced the comparisons between strategies. At the population level, (m)SEPT9 yielded incremental benefit at acceptable costs when it increased the fraction of the population screened more than it was substituted for other strategies.

CONCLUSIONS

(m)SEPT9 seems to be effective and cost-effective compared with no screening. To be cost-effective compared with established strategies, (m)SEPT9 or blood-based biomarkers with similar test performance characteristics would need to achieve substantially higher uptake and adherence rates than the alternatives. It remains to be proven whether colorectal cancer screening with a blood test can improve screening uptake or long-term adherence compared with established strategies.

IMPACT

Our study offers insights into the potential role of colorectal cancer screening with blood-based biomarkers.

摘要

背景

筛查可降低结直肠癌死亡率,但仍有许多人未接受筛查。血液检测筛查可能会提高筛查率。我们评估了新兴生物标志物(例如甲基化 Septin 9 DNA 血浆检测(mSEPT9))用于结直肠癌筛查的相对有效性和成本效益,并与现有策略进行了比较。

方法

我们使用经过验证的决策分析模型进行了成本效益分析,该模型比较了 mSEPT9、粪便潜血试验(FOBT)、粪便免疫化学试验(FIT)、乙状结肠镜检查和结肠镜检查,预测了终生收益和成本。

结果

在基础情况下,mSEPT9 可将结直肠癌发病率降低 35%至 41%,将结直肠癌死亡率降低 53%至 61%,其成本为 8400 美元至 11500 美元/每获得一个质量调整生命年,而不进行筛查。所有现有的筛查策略都比 mSEPT9 更有效。FIT 具有成本效益,优于 mSEPT9,是所有替代方案中的首选。随着时间的推移,筛查的参与率和纵向依从率对策略之间的比较有很大影响。在人群层面上,mSEPT9 在增加接受筛查的人群比例超过替代其他策略的情况下,以可接受的成本提供了额外的收益。

结论

与不筛查相比,mSEPT9 似乎具有有效性和成本效益。与现有策略相比,mSEPT9 或具有类似检测性能特征的血液生物标志物要具有成本效益,需要比替代方案实现更高的参与率和依从率。血液检测筛查是否能提高结直肠癌筛查的参与率或长期依从率,仍有待证实。

影响

本研究为血液检测筛查结直肠癌提供了新的见解。

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