Three-Year Interval for the Multi-Target Stool DNA Test for Colorectal Cancer Screening: A Longitudinal Study
Menée auprès de 2 044 participants, cette étude évalue l'efficacité, du point de vue du taux de détection de lésions colorectales précancéreuses ou cancéreuses, d'un test ADN fécal, multicible et triennal
Data supporting the clinical utility of mt-sDNA at the guideline-recommended 3-year interval have not been reported. Between April 2015 and July 2016, candidates for CRC screening whose providers prescribed the mt-sDNA test were enrolled. Participants with a positive baseline test were recommended for colonoscopy and completed the study. Those with a negative baseline test were followed annually for three years. In year 3, the mt-sDNA test was repeated and colonoscopy was recommended independent of results. Data were analyzed using the Predictive Summary Index (PSI), a measure of the gain in certainty for dichotomous diagnostic tests (where a positive value indicates a net gain), and by comparing observed versus expected CRCs and advanced precancerous lesions. Of 2,404 enrolled subjects, 2,044 (85%) had a valid baseline mt-sDNA result (284 [13.9%] positive and 1,760 [86.1%] negative). Following participant attrition, the year 3 intention-to-screen (ITS) cohort included 591 of 1,760 (33.6%) subjects with valid mt-sDNA and colonoscopy results, with no CRCs and 63 advanced precancerous lesions (22 [34.9%] detected by mt-sDNA) and respective PSI values of 0% (P=1) and 9.3% (P=0.01). The observed 3-year CRC yield was lower than expected (one-sided p=0.09), while that for advanced precancerous lesions was higher than expected (two-sided p=0.009). Repeat mt-sDNA screening at a 3-year interval resulted in a statistically significant gain in detection of advanced precancerous lesions. Due to absence of year 3 CRCs, the PSI estimate for CRC was underpowered and could not be reliably quantified. Larger studies are required to assess the CRC study findings.
Cancer Prevention Research , article en libre accès, 2021