Performance of Faecal Immunochemical Testing for Colorectal Cancer Screening at Varying Positivity Thresholds.
adverse event
colorectal cancer screening
colorectal neoplasia
cut‐off level
immunochemical faecal occult blood test
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
07 Oct 2024
07 Oct 2024
Historique:
revised:
07
04
2024
received:
07
03
2024
accepted:
19
09
2024
medline:
7
10
2024
pubmed:
7
10
2024
entrez:
7
10
2024
Statut:
aheadofprint
Résumé
The positivity thresholds of faecal immunochemical testing (FIT) in colorectal cancer (CRC) screening vary between countries. To explore the trade-off between colonoscopies performed, adverse events and lesions detected at different FIT thresholds in a Norwegian CRC screening trial. 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. 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. 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. Clinicaltrials.gov identifier: NCT01538550.
Sections du résumé
BACKGROUND
BACKGROUND
The positivity thresholds of faecal immunochemical testing (FIT) in colorectal cancer (CRC) screening vary between countries.
AIMS
OBJECTIVE
To explore the trade-off between colonoscopies performed, adverse events and lesions detected at different FIT thresholds in a Norwegian CRC screening trial.
METHODS
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
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
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
BACKGROUND
Clinicaltrials.gov identifier: NCT01538550.
Banques de données
ClinicalTrials.gov
['NCT01538550']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Helse Sør-Øst RHF
ID : 2015038
Organisme : Norwegian Parliament
Informations de copyright
© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.
Références
E. H. Schreuders, A. Ruco, L. Rabeneck, et al., “Colorectal Cancer Screening: A Global Overview of Existing Programmes,” Gut 64, no. 10 (2015): 1637–1649, https://doi.org/10.1136/gutjnl‐2014‐309086.
M. Navarro, A. Nicolas, A. Ferrandez, and A. Lanas, “Colorectal Cancer Population Screening Programs Worldwide in 2016: An Update,” World Journal of Gastroenterology 23, no. 20 (2017): 3632–3642, https://doi.org/10.3748/wjg.v23.i20.3632.
J. K. Lee, E. G. Liles, S. Bent, T. R. Levin, and D. A. Corley, “Accuracy of Fecal Immunochemical Tests for Colorectal Cancer: Systematic Review and Meta‐Analysis,” Annals of Internal Medicine 160, no. 3 (2014): 171, https://doi.org/10.7326/m13‐1484.
S. Aniwan, T. Ratanachu Ek, S. Pongprasobchai, et al., “The Optimal Cut‐Off Level of the Fecal Immunochemical Test for Colorectal Cancer Screening in a Country With Limited Colonoscopy Resources: A Multi‐Center Study From Thailand,” Asian Pacific Journal of Cancer Prevention: APJCP 18, no. 2 (2017): 405–412, https://doi.org/10.22034/apjcp.2017.18.2.405.
R. J. Steele, P. J. McDonald, J. Digby, et al., “Clinical Outcomes Using a Faecal Immunochemical Test for Haemoglobin as a First‐Line Test in a National Programme Constrained by Colonoscopy Capacity,” United European Gastroenterology Journal 1, no. 3 (2013): 198–205, https://doi.org/10.1177/2050640613489281.
E. Toes‐Zoutendijk, M. E. van Leerdam, E. Dekker, et al., “Real‐Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut‐Off Levels,” Gastroenterology 152, no. 4 (2017): 767–775.e2, https://doi.org/10.1053/j.gastro.2016.11.022.
A. I. Kooyker, E. Toes‐Zoutendijk, A. W. J. Opstal‐van Winden, et al., “The Second Round of the Dutch Colorectal Cancer Screening Program: Impact of an Increased Fecal Immunochemical Test Cut‐Off Level on Yield of Screening,” International Journal of Cancer 147, no. 4 (2020): 1098–1106, https://doi.org/10.1002/ijc.32839.
J. Murphy, S. Halloran, and A. Gray, “Cost‐Effectiveness of the Faecal Immunochemical Test at a Range of Positivity Thresholds Compared With the Guaiac Faecal Occult Blood Test in the NHS Bowel Cancer Screening Programme in England,” BMJ Open 7, no. 10 (2017): e017186, https://doi.org/10.1136/bmjopen‐2017‐017186.
L. Kaalby, M. Rasmussen, E. Zimmermann‐Nielsen, M. M. Buijs, and G. Baatrup, “Time to Colonoscopy, Cancer Probability, and Precursor Lesions in the Danish Colorectal Cancer Screening Program,” Clinical Epidemiology 11 (2019): 659–667, https://doi.org/10.2147/CLEP.S206873.
Cancer Research UK, “Faecal Immunochemical Test (FIT),” accessed October 24, 2023, https://www.cancerresearchuk.org/health‐professional/screening/bowel‐cancer‐screening#safetynetting2.
Red de programas de cribado de cáncer, “Programas de Cribado de Cáncer Colorrectal,” (2017). Informe de evaluación. accessed May 12, 2023, http://www.cribadocancer.com.
A. Pellat, J. Deyra, R. Coriat, and S. Chaussade, “Results of the National Organised Colorectal Cancer Screening Program With FIT in Paris,” Scientific Reports 8, no. 1 (2018): 4162, https://doi.org/10.1038/s41598‐018‐22481‐9.
T. Sarkeala, M. Färkkilä, A. Anttila, et al., “Piloting Gender‐Oriented Colorectal Cancer Screening With a Faecal Immunochemical Test: Population‐Based Registry Study From Finland,” BMJ Open 11, no. 2 (2021): e046667, https://doi.org/10.1136/bmjopen‐2020‐046667.
T. F. Imperiale, R. N. Gruber, T. E. Stump, T. W. Emmett, and P. O. Monahan, “Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps,” Annals of Internal Medicine 170, no. 5 (2019): 319–329, https://doi.org/10.7326/M18‐2390.
K. Selby, E. H. Levine, C. Doan, et al., “Effect of Sex, Age, and Positivity Threshold on Fecal Immunochemical Test Accuracy: A Systematic Review and Meta‐Analysis,” Gastroenterology 157, no. 6 (2019): 1494–1505, https://doi.org/10.1053/j.gastro.2019.08.023.
S. Hamza, V. Dancourt, C. Lejeune, J. M. Bidan, C. Lepage, and J. Faivre, “Diagnostic Yield of a One Sample Immunochemical Test at Different Cut‐Off Values in an Organised Screening Programme for Colorectal Cancer,” European Journal of Cancer (Oxford, England: 1990) 49, no. 12 (2013): 2727–2733, https://doi.org/10.1016/j.ejca.2013.03.023.
L. G. van Rossum, A. F. van Rijn, R. J. Laheij, et al., “Cutoff Value Determines the Performance of a Semi‐Quantitative Immunochemical Faecal Occult Blood Test in a Colorectal Cancer Screening Programme,” British Journal of Cancer 101, no. 8 (2009): 1274–1281, https://doi.org/10.1038/sj.bjc.6605326.
G. Grazzini, C. B. Visioli, M. Zorzi, et al., “Immunochemical Faecal Occult Blood Test: Number of Samples and Positivity Cutoff. What Is the Best Strategy for Colorectal Cancer Screening?,” British Journal of Cancer 100, no. 2 (2009): 259–265, https://doi.org/10.1038/sj.bjc.6604864.
C. Alvarez‐Urturi, M. Andreu, C. Hernandez, et al., “Impact of Age‐ and Gender‐Specific Cut‐Off Values for the Fecal Immunochemical Test for Hemoglobin in Colorectal Cancer Screening,” Digestive and Liver Disease 48, no. 5 (2016): 542–551, https://doi.org/10.1016/j.dld.2016.02.001.
H. Brenner, J. Qian, and S. Werner, “Variation of Diagnostic Performance of Fecal Immunochemical Testing for Hemoglobin by Sex and Age: Results From a Large Screening Cohort,” Clinical Epidemiology 10 (2018): 381–389, https://doi.org/10.2147/clep.s155548.
E. Wieten, E. H. Schreuders, S. A. V. Nieuwenburg, et al., “Effects of Increasing Screening Age and Fecal Hemoglobin Cutoff Concentrations in a Colorectal Cancer Screening Program,” Clinical Gastroenterology and Hepatology 14, no. 12 (2016): 1771–1777, https://doi.org/10.1016/j.cgh.2016.08.016.
E. Arana‐Arri, I. Idigoras, B. Uranga, et al., “Population‐Based Colorectal Cancer Screening Programmes Using a Faecal Immunochemical Test: Should Faecal Haemoglobin Cut‐Offs Differ by Age and Sex?,” BMC Cancer 17 (2017): 577, https://doi.org/10.1186/s12885‐017‐3555‐3.
S. Moss, C. Mathews, T. J. Day, et al., “Increased Uptake and Improved Outcomes of Bowel Cancer Screening With a Faecal Immunochemical Test: Results From a Pilot Study Within the National Screening Programme in England,” Gut 66, no. 9 (2017): 1631–1644, https://doi.org/10.1136/gutjnl‐2015‐310691.
J. E. East, W. S. Atkin, A. C. Bateman, et al., “British Society of Gastroenterology Position Statement on Serrated Polyps in the Colon and Rectum,” Gut 66, no. 7 (2017): 1181–1196, https://doi.org/10.1136/gutjnl‐2017‐314005.
K. R. Randel, A. L. Schult, E. Botteri, et al., “Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial,” Gastroenterology 160 (2020): 1085–1096.e5, https://doi.org/10.1053/j.gastro.2020.11.037.
M. B. Amin, S. B. Edge, F. L. Greene, et al., eds. AJCC Cancer Staging Manual (8th ed., New York: Springer, 2017).
J. S. Terhaar sive Droste, F. A. Oort, R. W. van der Hulst, et al., “Higher Fecal Immunochemical Test Cutoff Levels: Lower Positivity Rates but Still Acceptable Detection Rates for Early‐Stage Colorectal Cancers,” Cancer Epidemiology, Biomarkers & Prevention: A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology 20, no. 2 (2011): 272–280, https://doi.org/10.1158/1055‐9965.epi‐10‐0848.
T. Niedermaier, Y. Balavarca, and H. Brenner, “Stage‐Specific Sensitivity of Fecal Immunochemical Tests for Detecting Colorectal Cancer: Systematic Review and Meta‐Analysis,” American Journal of Gastroenterology 115, no. 1 (2020): 56–69, https://doi.org/10.14309/ajg.0000000000000465.
K. Selby, C. D. Jensen, J. K. Lee, et al., “Influence of Varying Quantitative Fecal Immunochemical Test Positivity Thresholds on Colorectal Cancer Detection: A Community‐Based Cohort Study,” Annals of Internal Medicine 169, no. 7 (2018): 439–447, https://doi.org/10.7326/M18‐0244.
T. R. de Wijkerslooth, E. M. Stoop, P. M. Bossuyt, et al., “Immunochemical Fecal Occult Blood Testing Is Equally Sensitive for Proximal and Distal Advanced Neoplasia,” Official Journal of the American College of Gastroenterology ACG 107, no. 10 (2012): 1570–1578, https://doi.org/10.1038/ajg.2012.249.
T. F. Imperiale, D. F. Ransohoff, S. H. Itzkowitz, et al., “Multitarget Stool DNA Testing for Colorectal‐Cancer Screening,” New England Journal of Medicine 370, no. 14 (2014): 1287–1297, https://doi.org/10.1056/NEJMoa1311194.
E. J. Grobbee, E. Wieten, B. E. Hansen, et al., “Fecal Immunochemical Test‐Based Colorectal Cancer Screening: The Gender Dilemma,” United European Gastroenterology Journal 5, no. 3 (2017): 448–454, https://doi.org/10.1177/2050640616659998.
J. Blom, C. Lowbeer, K. M. Elfstrom, et al., “Gender‐Specific Cut‐Offs in Colorectal Cancer Screening With FIT: Increased Compliance and Equal Positivity Rate,” Journal of Medical Screening 26, no. 2 (2019): 92–97, https://doi.org/10.1177/0969141318804843.
A. Reumkens, E. J. Rondagh, C. M. Bakker, B. Winkens, A. A. Masclee, and S. Sanduleanu, “Post‐Colonoscopy Complications: A Systematic Review, Time Trends, and Meta‐Analysis of Population‐Based Studies,” American Journal of Gastroenterology 111, no. 8 (2016): 1092–1101, https://doi.org/10.1038/ajg.2016.234.
S. T. Kothari, R. J. Huang, A. Shaukat, et al., “ASGE Review of Adverse Events in Colonoscopy,” Gastrointestinal Endoscopy 90, no. 6 (2019): 863–876.e33, https://doi.org/10.1016/j.gie.2019.07.033.
A. L. Schult, G. Hoff, Ø. Holme, et al., “Colonoscopy Quality Improvement After Initial Training: A Cross‐Sectional Study of Intensive Short‐Term Training,” Endoscopy International Open 11, no. 1 (2023): E117–E127, https://doi.org/10.1055/a‐1994‐6084.
E. Toes‐Zoutendijk, A. I. Kooyker, E. Dekker, et al., “Incidence of Interval Colorectal Cancer After Negative Results From First‐Round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age,” Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association 18, no. 7 (2020): 1493–1500, https://doi.org/10.1016/j.cgh.2019.08.021.
E. Wieten, C. M. de Klerk, A. van der Steen, et al., “Equivalent Accuracy of 2 Quantitative Fecal Immunochemical Tests in Detecting Advanced Neoplasia in an Organized Colorectal Cancer Screening Program,” Gastroenterology 155, no. 5 (2018): 1392–1399.e5, https://doi.org/10.1053/j.gastro.2018.07.021.