Interval colorectal cancers after negative faecal immunochemical test in the New Zealand Bowel Screening Pilot

Abstract

Objective Evaluate the diagnostic performance of faecal immunochemical test (FIT), identify risk factors for FIT-interval colorectal cancers (FIT-IC) and describe long-term outcomes of participants with colorectal cancers (CRC) in the New Zealand Bowel Screening Pilot (BSP).Design From 2012 to 2017, the BSP offered eligible individuals, aged 50–74 years, biennial screening using a quantitative FIT with positivity threshold of 15 µg haemoglobin (Hb)/g faeces. Retrospective review of prospectively maintained data extracted from the BSP Register and New Zealand Cancer Registry identified any CRC reported in participants who returned a definitive FIT result. Further details were obtained from hospital records. FIT-ICs were primary CRC diagnosed within 24 months of a negative FIT. Factors associated with FIT-ICs were identified using logistic regression.Results Of 387 215 individuals invited, 57.4% participated with 6.1% returning positive FIT results. Final analysis included 520 CRC, of which 111 (21.3%) met FIT-IC definition. Overall FIT sensitivity for CRC was 78.7% (95% CI=74.9% to 82.1%), specificity was 94.1% (95% CI=94.0% to 94.2%). In 78 (70.3%) participants with FIT-IC, faecal Hb was reported as undetectable. There were no significant associations between FIT-IC and age, sex, ethnicity and deprivation. FIT-ICs were significantly associated with proximal tumour location, late stage at diagnosis, high-grade tumour differentiation and subsequent round screens. Median follow-up time was 74 (2–124) months. FIT-IC had significantly poorer overall survival.Conclusion FIT sensitivity in BSP compared favourably to published data. FIT-ICs were more likely to be proximal tumours with poor long-term outcomes. Further lowering of FIT threshold would have minimal impact on FIT-IC.