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Sex- and Age-Stratified Outcomes of Colonoscopy Versus Faecal Immunochemical Testing: Post-Analysis of the COLONPREV Study.

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FIT and Colonoscopy Reduce CRC Mortality Equally Across Sex and Age Groups

A post-hoc stratified analysis of the COLONPREV randomised trial found that reductions in colorectal cancer-related mortality and incidence were consistent across sex and age subgroups for both faecal immunochemical testing and colonoscopy screening, though men and older participants retained persistently higher baseline cancer risk that neither strategy fully resolved. FIT consistently attracted higher participation than colonoscopy across all demographic subgroups, reinforcing its advantage in population-level uptake.

What Was Studied

This analysis addressed whether the effectiveness of colonoscopy versus biennial faecal immunochemical testing (FIT) for colorectal cancer screening differs when populations are subdivided by sex and age. The question carries practical importance because screening programmes must allocate resources across groups with different baseline risks, participation behaviours, and potential to benefit from each modality.

How It Was Studied

This was a pre-specified post-analysis of the COLONPREV study, a large Spanish randomised controlled trial (ClinicalTrials.gov: NCT00906997) in which presumptively healthy adults aged 50–69 years were randomly assigned either to a one-time screening colonoscopy or to biennial FIT. The eligible population comprised 26,332 individuals in the colonoscopy arm and 26,719 in the FIT arm. Outcomes examined included participation rates, crossover between screening strategies, colorectal cancer-related mortality, overall CRC incidence, all-cause mortality, and the diagnostic yield of premalignant lesions. All endpoints were stratified by sex and by two age bands: 50–59 years and 60–69 years. The parent COLONPREV trial had previously demonstrated non-inferiority of FIT to colonoscopy for CRC-related mortality.

What Was Observed

  • Mortality and incidence reductions were uniform across subgroups: The observed decreases in CRC-related mortality and CRC incidence were broadly consistent regardless of whether participants were male or female, or whether they were in the younger or older age band. This consistency held for both the colonoscopy and FIT arms, suggesting neither strategy confers a differential survival benefit in any particular demographic subgroup.
  • Persistent higher absolute risk in men and older participants: Despite equivalent relative reductions, CRC-related mortality, all-cause mortality, and CRC incidence remained measurably higher in men than in women and in those aged 60–69 compared with those aged 50–59. This gap was not eliminated by either screening approach, indicating that elevated baseline risk in these groups is not fully mitigated by the strategies studied.
  • FIT consistently outperformed colonoscopy on participation: Participation rates were higher for FIT than colonoscopy in every sex and age subgroup examined. Women and older individuals participated at higher rates overall, but the FIT advantage over colonoscopy was maintained irrespective of these demographic factors.
  • Colonoscopy detected more premalignant lesions across all subgroups: The diagnostic yield for premalignant precursor lesions — adenomas and advanced adenomas — was higher with colonoscopy than with FIT in all demographic strata analysed. This structural advantage of direct endoscopic inspection was consistent regardless of sex or age.

Why This Matters

These findings support the generalisability of FIT-based non-inferiority for CRC-related mortality across the major demographic subgroups typically targeted by average-risk screening programmes. For health systems designing population-wide campaigns, the data reinforce that FIT’s participation advantage is not confined to any single sex or age group, which has implications for programme reach. The finding that men’s elevated baseline CRC risk persists despite screening raises a research question about whether risk-stratified interval or intensity modifications could close that gap more effectively.

How to Read This Result

As a post-hoc stratified analysis, subgroup comparisons were not powered for formal statistical testing within each stratum, so the consistency of findings across groups should be interpreted as hypothesis-generating rather than definitive evidence of equivalence within any specific subpopulation.

Limitations

The abstract does not explicitly report study limitations.

Randomized Controlled Trial
Source
United European Gastroenterol J· PMID: 41715250
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