Abstract
ObjectiveIntegration of risk stratification into fecal immunochemical test (FIT) might aid in the suboptimal detection of advanced neoplasms by FIT in colorectal cancer (CRC) screening. A comparative study was conducted to evaluate the participation and diagnostic yield of the parallel combination of questionnaire-based risk assessment (QRA) and FIT, FIT-only and QRA-only strategies in a CRC screening program in China.MethodsThe study included 29,626 individuals aged 40−74 years and invited to participate in a CRC screening program in China. Participants were first invited to undertake QRA and one-time FIT (OC-sensor). Participants with positive QRA or FIT were deemed to be high-risk individuals who were recommended for subsequent colonoscopy. Participation, detection rate, and resource demand for colonoscopy were calculated and compared.ResultsOf the 29,626 invitees, 20,203 completed the parallel combination, 8,592 completed the QRA-only, and 11 completed the FIT-only strategy. For the parallel combination, FIT-only, and QRA-only strategies, the overall positivity rates were 10.2% (2,928/28,806), 5.4% (1,096/20,214), and 6.8% (1,944/28,795), respectively; the yield of advanced neoplasm per 10,000 invitees were 46.9 [95% confidence interval (95% CI): 39.8−55.4], 36.8 (95% CI: 30.5−44.4), and 12.2 (95% CI: 8.8−16.8), respectively; the positive predictive values for detecting advanced neoplasms among participants who completed colonoscopy were 4.7% (95% CI: 4.0%−5.6%), 9.9% (95% CI: 8.3%−11.9%), and 1.9% (95% CI: 1.3%−2.6%), respectively; the number of colonoscopies required to detect one advanced neoplasm was 11.4 (95% CI: 9.8−13.4), 5.7 (95% CI: 4.8−6.7), and 28.4 (95% CI: 20.7−39.2), respectively.ConclusionsThe parallel combination of QRA and FIT did not show superior efficacy for detecting advanced neoplasm compared with FIT alone in this CRC screening program.
Highlights
Colorectal cancer (CRC) emerged as the third most frequently diagnosed cancer worldwide in 2018 [1]
fecal immunochemical test (FIT)-only, and questionnaire-based risk assessment (QRA)-only strategies, the overall positivity rates were 10.2% (2,928/28,806), 5.4% (1,096/20,214), and 6.8% (1,944/28,795), respectively; the yield of advanced neoplasm per 10,000 invitees were 46.9 [95% confidence interval: 39.8−55.4], 36.8, and 12.2, respectively; the positive predictive values for detecting advanced neoplasms among participants who completed colonoscopy were 4.7%, 9.9%, and 1.9%, respectively; the number of colonoscopies required to detect one advanced neoplasm was 11.4, 5.7, and 28.4, respectively
By applying multivariate logistic regression, the results showed that, compared with participants having positive-QRA and negative-FIT results, participants having positive-FIT and negative-QRA results were more willing to accept colonoscopy, with odds ratios (OR) of 1.25
Summary
Colorectal cancer (CRC) emerged as the third most frequently diagnosed cancer worldwide in 2018 [1]. Given the long sojourn time and relatively high survival rate for patients with localized tumor stage, studies have demonstrated screening as the most effective strategy to reduce the mortality in colorectal cancer patients [3,4,5]. The benefits of CRC screening are well acknowledged, designing risk-adapted CRC screening strategies to improve their yield and cost-effectiveness is still a major challenge. A recently published metaanalysis demonstrated that the sensitivities of FIT for CRC and advanced adenoma were 0.91 [95% confidence interval (95% CI): 0.84−0.95] and 0.40 (95% CI: 0.33−0.47), respectively, at a positivity threshold of 10 μg Hb/g [8]. FIT has strengths such as low cost, ease of use, and high compliance rate, its low sensitivity for detecting advanced adenoma may limit its potential to reduce the incidence of CRC [9]. Only a few significant biomarkers have been successfully translated into clinical use because of high cost, technical barrier, or deficiency of prospective validation using a large sample size [12]
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