Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial

Kristin R Randel¹, Anna L Schult², Edoardo Botteri³, Geir Hoff⁴, Michael Bretthauer⁵, Giske Ursin⁶, Erik Natvig³, Paula Berstad³, Anita Jørgensen³, Per Kristian Sandvei⁷, Marie Ek Olsen⁸, Svein Oskar Frigstad⁹, Ole Darre-Næss¹⁰, Espen R Norvard¹¹, Nils Bolstad¹², Hartwig Kørner¹³, Arne Wibe¹⁴, Knut-Arne Wensaas¹⁵, Thomas de Lange¹⁶, Øyvind Holme¹⁷

Affiliations

¹ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Research and Development, Telemark Hospital Trust, Skien, Norway; Institute of Health and Society, University of Oslo, Oslo, Norway. Electronic address: Kristin.Ranheim.Randel@cancerregistry.no.
² Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
³ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.
⁴ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Research and Development, Telemark Hospital Trust, Skien, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
⁵ Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo; Norway Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
⁶ Cancer Registry of Norway, Oslo, Norway; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway; Department of Preventive Medicine, University of Southern California, Los Angeles, California.
⁷ Department of Gastroenterology, Østfold Hospital Trust, Grålum, Norway.
⁸ Department of Pathology, Østfold Hospital Trust, Grålum, Norway.
⁹ Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
¹⁰ Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway.
¹¹ Department of Pathology, Vestre Viken Hospital Trust Drammen, Drammen, Norway.
¹² Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
¹³ Department of Gastrointestinal Surgery, Stavanger University Hospital Stavanger, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.
¹⁴ Norwegian University of Science and Technology; Department of Surgery, St. Olav's hospital, Trondheim University Hospital, Trondheim, Norway.
¹⁵ Research Unit for General Practice, NORCE Norwegian Research Centre, Bergen, Norway.
¹⁶ Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Medical Research, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Department of Medicine, Sahlgrenska University Hospital-Mölndal, Sweden.
¹⁷ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo; Department of Medicine, Sorlandet Hospital Trust, Kristiansand, Norway.

PMID: 33227280
DOI: 10.1053/j.gastro.2020.11.037

Free article

Randomized Controlled Trial

Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial

Kristin R Randel et al. Gastroenterology. 2021 Mar.

Free article

. 2021 Mar;160(4):1085-1096.e5.

doi: 10.1053/j.gastro.2020.11.037. Epub 2020 Nov 21.

Authors

Affiliations

¹ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Research and Development, Telemark Hospital Trust, Skien, Norway; Institute of Health and Society, University of Oslo, Oslo, Norway. Electronic address: Kristin.Ranheim.Randel@cancerregistry.no.
² Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
³ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway.
⁴ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Research and Development, Telemark Hospital Trust, Skien, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
⁵ Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo; Norway Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
⁶ Cancer Registry of Norway, Oslo, Norway; Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway; Department of Preventive Medicine, University of Southern California, Los Angeles, California.
⁷ Department of Gastroenterology, Østfold Hospital Trust, Grålum, Norway.
⁸ Department of Pathology, Østfold Hospital Trust, Grålum, Norway.
⁹ Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
¹⁰ Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway.
¹¹ Department of Pathology, Vestre Viken Hospital Trust Drammen, Drammen, Norway.
¹² Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
¹³ Department of Gastrointestinal Surgery, Stavanger University Hospital Stavanger, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.
¹⁴ Norwegian University of Science and Technology; Department of Surgery, St. Olav's hospital, Trondheim University Hospital, Trondheim, Norway.
¹⁵ Research Unit for General Practice, NORCE Norwegian Research Centre, Bergen, Norway.
¹⁶ Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Medical Research, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Department of Medicine, Sahlgrenska University Hospital-Mölndal, Sweden.
¹⁷ Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo; Department of Medicine, Sorlandet Hospital Trust, Kristiansand, Norway.

PMID: 33227280
DOI: 10.1053/j.gastro.2020.11.037

Abstract

Background & aims: The comparative effectiveness of sigmoidoscopy and fecal immunochemical testing (FIT) for colorectal cancer (CRC) screening is unknown.

Methods: Individuals aged 50-74 years living in Southeast Norway were randomly invited between 2012 and 2019 to either once-only flexible sigmoidoscopy or FIT screening every second year. Colonoscopy was recommended after sigmoidoscopy if any polyp of ≥10 mm, ≥3 adenomas, any advanced adenomas, or CRC was found or, subsequent to, FIT >15 μg hemoglobin/g feces. Data for this report were obtained after complete recruitment in both groups and included 2 full FIT rounds and part of the third round. Outcome measures were participation, neoplasia detection, and adverse events. Age-standardized detection rates and age-adjusted odds ratios (ORs) were calculated.

Results: We included 139,291 individuals: 69,195 randomized to sigmoidoscopy and 70,096 to FIT. The participation rate was 52% for sigmoidoscopy, 58% in the first FIT round, and 68% for 3 cumulative FIT rounds. Compared to sigmoidoscopy, the detection rate for CRC was similar in the first FIT round (0.25% vs 0.27%; OR, 0.92; 95% confidence interval [CI], 0.75-1.13) but higher after 3 FIT rounds (0.49% vs 0.27%; OR, 1.87; 95% CI, 1.54-2.27). Advanced adenoma detection rate was lower in the first FIT round compared to sigmoidoscopy at 1.4% vs 2.4% (OR, 0.57; 95% CI, 0.53-0.62) but higher after 3 cumulative FIT rounds at 2.7% vs 2.4% (OR, 1.14; 95% CI, 1.05-1.23). There were 33 (0.05%) serious adverse events in the sigmoidoscopy group compared to 47 (0.07%) in the FIT group (P = .13).

Conclusions: Participation was higher and more CRC and advanced adenomas were detected with repeated FIT compared to sigmoidoscopy. The risk of perforation and bleeding was comparable. Clinicaltrials.gov, Number: NCT01538550.

Keywords: Adverse Events; Mass Screening; Participation; Screening Yield.

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Comment in

Merits, Challenges, and Limitations of Randomized Trials on Colorectal Cancer Screening Effectiveness.
Brenner H, Cross AJ. Brenner H, et al. Gastroenterology. 2021 Mar;160(4):1009-1011. doi: 10.1053/j.gastro.2020.12.029. Epub 2021 Feb 5. Gastroenterology. 2021. PMID: 33359088 No abstract available.

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Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial

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Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial

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