Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds

Kristin Ranheim Randel; Edoardo Botteri; Thomas de Lange; Anna Lisa Schult; Sigrun Losada Eskeland; Badboni El-Safadi; Espen R Norvard; Nils Bolstad; Michael Bretthauer; Geir Hoff; Øyvind Holme

doi:10.1111/apt.18314

Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds

Aliment Pharmacol Ther. 2024 Oct 7. doi: 10.1111/apt.18314. Online ahead of print.

Authors

Kristin Ranheim Randel^{1

2

3}, Edoardo Botteri^{3

4}, Thomas de Lange^{5

6}, Anna Lisa Schult^{3

7}, Sigrun Losada Eskeland⁷, Badboni El-Safadi⁸, Espen R Norvard⁹, Nils Bolstad¹⁰, Michael Bretthauer^{11

12}, Geir Hoff^{1

3}, Øyvind Holme^{2

13}

Affiliations

¹ Department of Research and Development, Telemark Hospital, Skien, Norway.
² Institute of Health and Society, University of Oslo, Oslo, Norway.
³ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.
⁴ Department of Research, Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.
⁵ Department of Medicine, Sahlgrenska University Hospital-Mölndal, Region Västra Götaland, Sweden.
⁶ Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁷ Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway.
⁸ Department of Gastroenterology, Østfold Hospital Trust, Grålum, Norway.
⁹ Department of Pathology, Vestre Viken Hospital Trust Drammen, Drammen, Norway.
¹⁰ Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
¹¹ Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
¹² Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.
¹³ Department of Medicine, Sørlandet Hospital Kristiansand, Kristiansand, Norway.

PMID: 39373173
DOI: 10.1111/apt.18314

Abstract

Background: The positivity thresholds of faecal immunochemical testing (FIT) in colorectal cancer (CRC) screening vary between countries.

Aims: To explore the trade-off between colonoscopies performed, adverse events and lesions detected at different FIT thresholds in a Norwegian CRC screening trial.

Methods: We included first participation in biennial FIT screening for 47,265 individuals aged 50-74 years. Individuals with FIT > 15 μg Hb/g faeces were referred for colonoscopy. We estimated the number of colonoscopies, adverse events, screen-detected CRCs, advanced adenomas and serrated lesions expected at FIT thresholds currently or recently used in other European countries ranging between 20 and 150 μg/g.

Results: At the 15 μg/g threshold (Norway), 3705 participants underwent colonoscopy, of whom 203 had CRC, 1119 advanced adenomas and 256 advanced serrated lesions. Using a 47 μg/g threshold, 1826 (49.3%) individuals would have undergone colonoscopy, and 154 (75.9%) would have been diagnosed with CRC, 702 (62.7%) with advanced adenoma and 128 (50.0%) with advanced serrated lesion compared to the 15 μg/g threshold. At 150 μg/g, the corresponding figures would have been 838 (22.6%) undergoing colonoscopy, 114 (56.2%) with CRC, 345 (30.8%) advanced adenoma and 54 (21.1%) advanced serrated lesions. The detection rate of stage I CRC was 0.22% at 15 μg/g and 0.11% at 150 μg/g. Post-colonoscopy bleeding rates were 0.8% and 1.7%, respectively.

Conclusions: Increasing the FIT threshold reduces colonoscopy demand, but substantially decreases lesion detection and unfavourably changes CRC stage distribution. The risk of adverse events at colonoscopy increased with FIT threshold, requiring country-specific information on adverse events.

Trial registration: Clinicaltrials.gov identifier: NCT01538550.

Keywords: adverse event; colorectal cancer screening; colorectal neoplasia; cut‐off level; immunochemical faecal occult blood test.

Associated data

ClinicalTrials.gov/NCT01538550

Abstract

Associated data

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