Colorectal Cancer Screening by Aasma Shaukat & John I. Allen

Author:Aasma Shaukat & John I. Allen
Language: eng
Format: epub
Publisher: Springer New York, New York, NY

At predetermined cutoffs, Cologuard detected significantly more lesions than did FIT for all categories: 93 % versus 73 % for curable-stage CRC (Fig. 6.3a); 68 % versus 45 % for adenomas with high-grade dysplasia (Fig. 6.3b); 66 % versus 42 % for adenomas ≥ 2 cm, 42 % versus 24 % for all advanced adenomas, 17 % versus 8 % for non-advanced polyps (Fig. 6.3d); and, 43 % versus 5 % for sessile serrated polyps ≥ 1 cm (Fig. 6.3b). As we have previously noted [21], CRC detection was not affected by stage or site (Fig. 6.3c), and polyp detection increased in proportion to lesion size (Fig. 6.3d). Based on patients with normal colonoscopy, specificity was lower with Cologuard at 90 % compared to FIT at 95 %. Age influenced Cologuard specificity which was 94 % in those < 65 years of age and 87 % in those ≥ 65 years of age. Given the known variability in colonoscopy detection rates, it is possible that some of the “false-positive” stool test results represent lesions missed by the criterion standard. In addition to these pivotal trial data, rigorous technical studies demonstrate reliability of Cologuard performance in compliance with the highest regulatory standards for diagnostic testing.

Fig. 6.3Results of the multi-target sDNA test and commercial fecal immunochemical test in analyzed subgroups. Numbers in parentheses ( ) are sample sizes. a sensitivity for colorectal cancer by stage (1 The stage of one colorectal cancer was not available), b sensitivity for cancer and advanced precancerous lesions by location (2 The location of one advanced precancerous lesion was not available), c sensitivity for advanced precancerous lesions: higher risk subsets, d sensitivity for advanced precancerous lesions by size. (Adapted from Ref. 30. With permission from Massachusetts Medical Society)

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