Objective: To assess the performance of the Sensa fecal occult blood test (FOBT) in a population-based screening program.
Setting: Manitoba, Canada.
Methods: This historical cohort study included individuals 52 to 74 years of age diagnosed with colorectal cancer (CRC) from 2008 to 2013. CRCs were categorized by detection following a screening program FOBT (Sensa), non-program FOBT (non-Sensa), or no FOBT. Screening program CRCs were classified as program-detected, interval program, or non-compliant. Logistic regression was used to compare characteristics by detection mode. Cox regression adjusted for lead-time was used to examine the effect of detection mode on survival.
Results: 1,498 individuals were diagnosed with CRC; 132 (8.8%) had a screening program FOBT, 626 (41.8%) had a non-program FOBT, and 740 (49.4%) had no FOBT. Of the screening program FOBT CRCs, 72 were program-detected (54.5%), 42 were interval program (31.8%), and 18 were non-compliant (13.6%). Sensa interval cancer rate was 37.4% and sensitivity was 63.1% (95% Confidence Interval (CI): 54.3%-72.0%). The risk of death for individuals that had a non-program (Hazard ratio (HR) = 0.57, 95% CI:0.44-0.75) or a screening program FOBT (HR = 0.55, 95% CI:0.31-0.97) was lower than no FOBT. There was no significant difference in the risk of death for interval, non-compliant, and non-program CRCs compared to program-detected CRCs. Adjusting for lead time bias, sex, income quintile, tumour location, and age at diagnosis did not appreciably change the risk estimates.
Conclusion: More than one-third of CRCs may not be detected by Sensa. There may be no difference in survival between CRC detected by Sensa and non-Sensa FOBTs.