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多靶点粪便 DNA 与 CT 结肠成像用于非侵入性结直肠癌筛查的诊断性能。

Diagnostic Performance of Multitarget Stool DNA and CT Colonography for Noninvasive Colorectal Cancer Screening.

机构信息

From the Department of Radiology (P.J.P., P.M.G., B.W.) and the Department of Medicine (N.D.Y., J.M.W.), University of Wisconsin School of Medicine & Public Health, E3/311 Clinical Science Center, 600 Highland Ave, Madison, WI 53792-3252; and Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy (C.H.).

出版信息

Radiology. 2020 Oct;297(1):120-129. doi: 10.1148/radiol.2020201018. Epub 2020 Aug 11.

DOI:10.1148/radiol.2020201018
PMID:32779997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7945994/
Abstract

BackgroundMultitarget stool DNA (mt-sDNA) screening has increased rapidly since simultaneous approval by the U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services in 2014, whereas CT colonography screening remains underused and is not covered by Centers for Medicare and Medicaid Services.PurposeTo report postapproval clinical experience with mt-sDNA screening for colorectal cancer (CRC) and compare results with CT colonography screening at the same center.Materials and MethodsIn this retrospective cohort study, asymptomatic adults underwent clinical mt-sDNA screening during a 5-year interval (2014-2019). Electronic medical records were searched to verify test results and document subsequent optical colonoscopy and histopathologic findings. A similar analysis was performed for CT colonography screening during a 15-year interval (2004-2019), with consideration of thresholds for positivity of both 6-mm and 10-mm polyp sizes. χ or two-sample tests were used for group comparisons.ResultsA total of 3987 asymptomatic adult patients (mean age, 64 years ± 9 [standard deviation]; 2567 women) underwent mt-sDNA screening and 9656 patients (mean age, 57 years ± 8; 5200 women) underwent CT colonography. Test-positive rates for mt-sDNA and for 6-mm- and 10-mm-threshold CT colonography were 15.2%, 16.4%, and 6.7%, respectively. Optical colonoscopy follow-up rates for positive results of mt-sDNA and 6-mm- and 10-mm-threshold CT colonography were 13.1%, 12.3%, and 5.9%, respectively. Positive predictive values (PPVs) for any neoplasm 6 mm or greater, advanced neoplasia, and CRC for mt-sDNA were 54.2%, 22.7%, and 1.9% respectively; for 6-mm-threshold CT colonography, PPVs were 76.8%, 44.3%, and 2.7%; for 10-mm-threshold CT colonography, PPVs were 84.5%, 75.2%, and 5.2%, respectively ( < .001 for mt-sDNA vs CT colonography for all except 6-mm CRC at CT colonography). For mt-sDNA versus 6-mm-threshold CT colonography, overall detection rates for advanced neoplasia were 2.7% and 5.0%, respectively ( < .001); corresponding detection rates for CRC were 0.23% and 0.31%, respectively ( = .43).ConclusionThe detection rates of advanced neoplasia at CT colonography screening were greater than those of multitarget stool DNA. Detection rates were similar for colorectal cancer.© RSNA, 2020See also the editorial by Yee in this issue.

摘要

背景 自 2014 年美国食品和药物管理局与医疗保险和医疗补助服务中心同时批准以来,多靶点粪便 DNA(mt-sDNA)筛查迅速增加,而 CT 结肠成像筛查的应用仍不充分,且不在医疗保险和医疗补助服务中心的覆盖范围内。

目的 报告 mt-sDNA 筛查结直肠癌(CRC)的批准后临床经验,并与同一中心的 CT 结肠成像筛查结果进行比较。

材料与方法 在这项回顾性队列研究中,无症状成年人在 5 年(2014-2019 年)期间接受临床 mt-sDNA 筛查。检索电子病历以验证检测结果,并记录随后的光学结肠镜检查和组织病理学发现。对 CT 结肠成像筛查进行了类似的分析,考虑了 6-mm 和 10-mm 息肉大小的阳性阈值。使用 χ 或两样本 t 检验进行组间比较。

结果 共有 3987 名无症状成年患者(平均年龄 64 岁 ± 9[标准差];2567 名女性)接受了 mt-sDNA 筛查,9656 名患者(平均年龄 57 岁 ± 8;5200 名女性)接受了 CT 结肠成像筛查。mt-sDNA 和 6-mm-和 10-mm 阈值 CT 结肠成像的阳性检出率分别为 15.2%、16.4%和 6.7%。mt-sDNA 和 6-mm-和 10-mm 阈值 CT 结肠成像阳性结果的光学结肠镜检查随访率分别为 13.1%、12.3%和 5.9%。mt-sDNA 对任何 6 mm 或更大的肿瘤、高级别肿瘤和 CRC 的阳性预测值(PPV)分别为 54.2%、22.7%和 1.9%;6-mm 阈值 CT 结肠成像的 PPV 分别为 76.8%、44.3%和 2.7%;10-mm 阈值 CT 结肠成像的 PPV 分别为 84.5%、75.2%和 5.2%(除 6-mm CRC 外,mt-sDNA 与 CT 结肠成像的所有比较均<.001)。对于 mt-sDNA 与 6-mm 阈值 CT 结肠成像,高级别肿瘤的总体检出率分别为 2.7%和 5.0%(<.001);CRC 的相应检出率分别为 0.23%和 0.31%(=.43)。

结论 CT 结肠成像筛查高级别肿瘤的检出率高于多靶点粪便 DNA。结直肠癌的检出率相似。

©RSNA,2020 参见本期 Yee 的社论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0955/7945994/e560a96ca650/nihms-1666958-f0005.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0955/7945994/e5350ab829a8/nihms-1666958-f0002.jpg
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