Incidence of Interval Colorectal Cancer After Negative Results From First-round Fecal Immunochemical Screening Tests, by Cutoff Value and Participant Sex and Age

Abstract Background & Aims We evaluated the incidence of colorectal cancer (CRC) between the first and second rounds of screening (interval cancers) with the FOB-Gold fecal immunochemical test (FIT), and the effects of different cutoff values and patient sex and age. Methods We collected data from participants in a population-based CRC screening program in the Netherlands in 2014 who had a negative result from a first-round of FIT screening. We calculated the cumulative incidence of interval cancer after a negative result from a FIT and the sensitivity of the FIT for detection of CRC at a low (15 μg Hb/g feces) and high (47 μg Hb/g feces) cutoff values. Results Among the 485,112 participants with a negative result from a FIT, 544 interval cancers were detected; 126 were in the 111,800 participants with negative results from a FIT with the low cutoff value and 418 were in the 373,312 FIT participants with negative results from a FIT with the high cutoff value. The mean age of participants who received the test with the low cutoff was 72.0 years and the mean age of participants who received the test with the high cutoff was 66.7 years. The age-adjusted 2-year cumulative incidence of interval cancer after a negative result from a FIT were 9.5 per 10,000 persons at the low cutoff vs 13.8 per 10,000 persons at the high cutoff (P Conclusions In an analysis of data from a FIT population-based screening program in the Netherlands, we found that incidence of interval CRC after a negative result from a FIT to be low. Although the sensitivity of detection of CRC decreased with a higher FIT cutoff value, it remained above 80%.