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. 2020 Apr;18(4):864-871.
doi: 10.1016/j.cgh.2019.07.057. Epub 2019 Aug 5.

Low Incidence of Aerodigestive Cancers in Patients With Negative Results From Colonoscopies, Regardless of Findings From Multitarget Stool DNA Tests

Barry M Berger  1 , John B Kisiel  2 , Thomas F Imperiale  3 , Daniel J Geenen  4 , Russell I Heigh  5 , Douglas W Mahoney  2 , Robert J Hilsden  6
Affiliations

Low Incidence of Aerodigestive Cancers in Patients With Negative Results From Colonoscopies, Regardless of Findings From Multitarget Stool DNA Tests

Barry M Berger et al. Clin Gastroenterol Hepatol. 2020 Apr.

Abstract

Background & aims: We aimed to compare the incidence of aerodigestive cancers in persons with negative results from colonoscopies and positive vs negative results from multitarget stool DNA tests for colorectal cancer and vs expected incidence.

Methods: We performed a retrospective cohort study of 1216 subjects with comprehensive patient records and/or cancer registry data from 3 medical centers in North America. Subjects had no neoplasia or only nonadvanced adenomas, based on screening colonoscopy, and either negative results (concordant with colonoscopy, n = 1011) or positive results (discordant colonoscopy, n = 205) from the multitarget stool DNA test. Outcomes included aerodigestive cancers in discordant vs concordant groups and comparison of observed aerodigestive cancer incidence between the groups and compared with expected incidence for the population, based on the Surveillance, Epidemiology, and End Results (SEER) data.

Results: Median follow-up times were comparable between subjects in the discordant (5.3 y; interquartile range, 3.5-5.8 y) and concordant (5.4 y; interquartile range, 3.7-5.8 y) groups. Aerodigestive cancers developed in 5 subjects in the discordant group vs 11 subjects in the concordant group (crude risk ratio, 2.3; 95% CI, 0.8-6.6; adjusted risk ratio, 2.2; 95% CI, 0.8-6.2; P = .151). The incidence of aerodigestive cancer was lower in the concordant group than the expected incidence based on SEER data (risk ratio, 0.4; 95% CI, 0.2-0.6; P = .0008). The incidence of aerodigestive cancer was not significantly greater in the population in the discordant group than the expected incidence based on SEER data (risk ratio, 0.8; 95% CI, 0.3-1.9; P = .599).

Conclusions: In a retrospective study with a median follow-up time of 5.4 years, incident aerodigestive cancers were uncommon among subjects with negative findings from colonoscopies, regardless of discordant or concordant results from multitarget stool DNA tests. Patients with negative results from high-quality colonoscopies therefore should not undergo further testing.

Keywords: Cohort Study; Colon; Colonoscopy; Control; Neoplasms; Prevention.

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Conflict of interest statement

Conflicts of interest

These authors disclose the following: Barry M. Berger is a clinical consultant to and equity holder of Exact Sciences; John B. Kisiel and Douglas W. Mahoney are listed as inventors and may receive royalties from Mayo Clinic and Exact Sciences from ownership of intellectual property; and Thomas F. Imperiale and Russell I. Heigh are co-investigators on research studies sponsored by Exact Sciences. The remaining authors disclose no conflicts.

Figures

Figure 1.
Figure 1.
Study flow chart. mt-sDNA, multitarget stool DNA.
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References

    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin 2018;68:7–30. - PubMed
    1. US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Screening for colorectal cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2016;315:2564–2575. - PubMed
    1. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 2017;112:1016–1030. - PubMed
    1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: colorectal cancer screening version 2. Available from: https://www.nccn.org/professionals/physician_gls/pdf/colorectal_screenin.... Updated 2016. Accessed September 21, 2018.
    1. American Cancer Society. Colorectal cancer: early detection, diagnosis, and staging. Atlanta: American Cancer Society. Available from: http://www.cancer.org/cancer/colonandrectumcancer/moreinformation/colona.... Updated April 24, 2016. Accessed: May 25, 2017.

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