Benefits of colorectal cancer screening using fecal immunochemical testing with varying positivity thresholds by age and sex

J Natl Cancer Inst. 2025 Nov 1;117(11):2219-2228. doi: 10.1093/jnci/djaf149.

Abstract

Background: Fecal immunochemical test (FIT) performance for colorectal cancer screening varies by age and sex, yet most FIT-based screening programs use uniform positivity thresholds. This study assessed the potential benefits of stratifying FIT thresholds based on age and sex.

Methods: We conducted a meta-analysis of FIT sensitivity and specificity at various positivity thresholds by age and sex. We then used these estimates in 2 microsimulation models of colorectal cancer and projected lifetime clinical outcomes, incremental costs, and quality-adjusted life-years (QALYs) gained from age- and sex-stratified FIT strategies. FIT thresholds ranged from 10 to 50 µg hemoglobin per gram of feces.

Results: For current uniform FIT screening (20 µg hemoglobin/gram of feces), models projected 85.67 to 122.15 QALYs gained at incremental costs of ‒$982 to $504 per 1000 individuals compared with no screening. At equivalent costs to current uniform screening, only 1 model found stratified FIT approaches cost-effective, yielding a marginal increase of 1.04 and 1.10 QALYs gained/1000 female and male individuals, respectively. At a willingness-to-pay threshold of $100 000/QALYs gained, both models found stratified FIT cutoffs to be the best strategy, with cutoffs being equal to or higher for males and lowest at older ages (70-75 years). Uniform strategies showed comparable effectiveness, falling within 1 quality-adjusted life-day per person of efficient strategies at up to $112 more per person. Results were sensitive to FIT test performance characteristics and 1-time setup costs.

Conclusion: Stratifying FIT thresholds by age and sex may be cost-effective compared to current screening. The gain in expected health benefits with stratified FIT screening, however, is likely small.

Publication types

  • Meta-Analysis

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Colorectal Neoplasms* / diagnosis
  • Colorectal Neoplasms* / economics
  • Colorectal Neoplasms* / epidemiology
  • Colorectal Neoplasms* / prevention & control
  • Cost-Benefit Analysis
  • Cost-Effectiveness Analysis
  • Early Detection of Cancer* / economics
  • Early Detection of Cancer* / methods
  • Feces* / chemistry
  • Female
  • Hemoglobins* / analysis
  • Humans
  • Male
  • Mass Screening* / economics
  • Mass Screening* / methods
  • Middle Aged
  • Occult Blood*
  • Quality-Adjusted Life Years
  • Sensitivity and Specificity
  • Sex Factors

Substances

  • Hemoglobins