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Research Article

28 May 2020

Can a biomarker triage test reduce colonoscopy burden in fecal immunochemical test screening?

Authors: Marjolein JE Greuter https://orcid.org/0000-0002-6151-3382 [email protected], Beatriz Carvalho, Meike de Wit, Evelien Dekker, Manon CW Spaander, Gerrit A Meijer, Manon van Engeland, and Veerle MH CoupéAuthor Info & Affiliations

Publication: Journal of Comparative Effectiveness Research

Volume 9, Number 8

https://doi.org/10.2217/cer-2019-0130

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Abstract

Aim: To assess the potential of biomarker triage testing (BM-TT) in the Dutch colorectal cancer (CRC) screening program. Materials & methods: Using the Adenoma and Serrated pathway to Colorectal CAncer model, we simulated fecal immunochemical test (FIT)₄₇-screening and various FIT plus BM-TT screening scenarios in which only individuals with both a positive FIT and BM-TT are referred to colonoscopy. Results: Adding a low polyp sensitivity BM-TT to FIT-screening reduced colonoscopy burden (89–100%) while increasing CRC mortality (27–41%) compared with FIT₄₇-screening only. The FIT plus high polyp sensitivity BM-TT scenarios also decreased colonoscopy burden (71–89%) while hardly affecting CRC mortality (FIT₄₇ 0–4% increase, FIT₁₅ 2–7% decrease). Conclusion: Adding a BM-TT to FIT-screening considerably reduces colonoscopy burden, but could also decrease screening effectiveness. Combining FIT₁₅ with a high polyp sensitivity BM-TT seems most promising.

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References

Papers of special note have been highlighted as: • of interest; •• of considerable interest

1.

Greuter MJE, Demirel E, Lew J-B et al. Long-term impact of the Dutch colorectal cancer screening program on cancer incidence and mortality-model-based exploration of the serrated pathway. Cancer Epidemiol. Biomarkers Prev. 25(1), 135–144 (2016).

2.

Rijksintituut voor Volksgezondheid en Milieu. Monitoring evaluatie bevolkingsonderzoek darmkanker (2018). www.iknl.nl/getmedia/35d96a38-d019-4846-b7ac-b000ddff9a1a/2018_Monitor-darmkanker_definitief.pdf

3.

de Wijkerslooth TR, de Haan MC, Stoop EM et al. Burden of colonoscopy compared to non-cathartic CT-colonography in a colorectal cancer screening programme: randomised controlled trial. Gut 61(11), 1552–1559 (2012).

4.

Rex DK, Petrini JL, Baron TH et al. Quality indicators for colonoscopy. Gastrointest. Endosc. 63(Suppl. 4), S16–S28 (2006).

5.

Imperiale TF, Ransohoff DF, Itzkowitz SH et al. Multitarget stool DNA testing for colorectal-cancer screening. N. Engl. J. Med. 370(14), 1287–1297 (2014).

• Cologuard will not be cost effective the as triage test as the sensitivities are considerably lower than the ≥60% polyp sensitivity we considered for the high polyp sensitivity biomarker triage testing.

6.

Bosch LJW, de Wit M, Pham TV et al. Novel stool-based protein biomarkers for improved colorectal cancer screening: a case–control study. Ann. Intern. Med. 167(12), 855–866 (2017).

•• The development of stool-based biomarker tests is of broad and current interest.

7.

Bosch LJW, Mongera S, Terhaar Sive Droste JS et al. Analytical sensitivity and stability of DNA methylation testing in stool samples for colorectal cancer detection. Cell. Oncol. Dordr. 35(4), 309–315 (2012).

8.

Greuter MJ, Xu X-M, Lew J-B et al. Modeling the adenoma and serrated pathway to colorectal cAncer (ASCCA). Risk Anal. 34(5), 889–910 (2014).

9.

IJspeert JEG, Vermeulen L, Meijer GA, Dekker E. Serrated neoplasia-role in colorectal carcinogenesis and clinical implications. Nat. Rev. Gastroenterol. Hepatol. 12(7), 401–409 (2015).

10.

Stoop EM, de Haan MC, de Wijkerslooth TR et al. Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial. Lancet Oncol. 13(1), 55–64 (2012).

11.

IKNL. Cijfers over kanker (2011). www.cijfersoverkanker.nl/

12.

Lew JB, Greuter MJE, Caruana M et al. Validation of microsimulation models against alternative model predictions and long-term colorectal cancer incidence and mortality outcomes of randomised-controlled trials. Submitted to Med Decis Making. [Unpublished Data, 2019].

13.

Nederlandse Vereniging van Maag-, Darm- en Leverartsen. Nederlandse Richtlijn Coloscopie Surveillance (2013). www.mdl.nl/sites/www.mdl.nl/files/richlijnen/Richtlijn_Coloscopie_Surveillance_definitief_2013.pdf

14.

van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am. J. Gastroenterol. 101(2), 343–350 (2006).

15.

Leggett B, Whitehall V. Role of the serrated pathway in colorectal cancer pathogenesis. Gastroenterology 138(6), 2088–2100 (2010).

16.

Ness RM, Holmes AM, Klein R, Dittus R. Utility valuations for outcome states of colorectal cancer. Am. J. Gastroenterol. 94(6), 1650–1657 (1999).

17.

Niv Y, Bogolavski I, Ilani S et al. Impact of colonoscopy on quality of life. Eur. J. Gastroenterol. Hepatol. 24(7), 781–786 (2012).

18.

Cenin DR, Naber SK, de Weerdt AC et al. Cost–effectiveness of personalized screening for colorectal cancer based on polygenic risk and family history. Cancer Epidemiol. Biomark. Prev. 29(1), 10–21 (2020).

19.

Health Council of the Netherlands. Population Screening Act: national population screening programme for bowel cancer. The Hague: Health Council of the Netherlands (2009). Publication no. 2009.13. www.gezondheidsraad.nl/documenten/adviezen/2009/11/17/bevolkingsonderzoek-naar-darmkanker

20.

Lüning TH, Keemers-Gels ME, Barendregt WB, Tan ACITL Rosman C. Colonoscopic perforations: a review of 30,366 patients. Surg. Endosc. 21(6), 994–997 (2007).

21.

Nederlandse Zorgautoriteit (2013). www.nza.nl/regelgeving/tarieven

22.

Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann. Intern. Med. 149(9), 638–658 (2008).

23.

Tilson L, Sharp L, Usher C et al. Cost of care for colorectal cancer in Ireland: a health care payer perspective. Eur. J. Health Econ. 13(4), 511–524 (2012).

24.

Central Bureau for Statistics (2019). www.cbs.nl

25.

Siegel JE, Torrance GW, Russell LB, Luce BR, Weinstein MC, Gold MR. Guidelines for pharmacoeconomic studies. Recommendations from the panel on cost–effectiveness in health and medicine. Panel on cost–effectiveness in health and medicine. Pharmacoeconomics 11(2), 159–168 (1997).

26.

Solomon D. Chapter 14: role of triage testing in cervical cancer screening. JNCI Monogr. 2003(31), 97–101 (2003).

• Triage testing is used in other screening programs to reduce screening burden.

27.

Ladabaum U, Mannalithara A. Comparative effectiveness and cost effectiveness of a multitarget stool DNA test to screen for colorectal neoplasia. Gastroenterology 151(3), 427–439.e6 (2016).

28.

Carvalho B, Diosdado B, Terhaar Sive Droste JS et al. Evaluation of cancer-associated DNA copy number events in colorectal (advanced) adenomas. Cancer Prev. Res. 11(7), 403–412 (2018).

29.

Wen-Sy Tsai AN, Chang Gung Memorial Hospital T, Johns Hopkins Hospital B et al. Prospective clinical study of circulating tumor cells for colorectal cancer screening (2018). https://meetinglibrary.asco.org/record/155738/abstract

30.

Liedenbaum MH, van Rijn AF, de Vries AH et al. Using CT colonography as a triage technique after a positive faecal occult blood test in colorectal cancer screening. Gut 58(9), 1242–1249 (2009).

•• Computed tomography colonography is unlikely to be an efficient triage technique in fecal immunochemical test-based screening.

31.

Nielsen HJ, Christensen IJ, Andersen B et al. Serological biomarkers in triage of FIT-positive subjects? Scand. J. Gastroenterol. 52(6–7), 742–744 (2017).

•• Preliminary results of a triage test using serological biomarkers in fecal immunochemical test-positive individuals.

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