Offering patients a combination of fecal immunochemical testing (FIT) and primary colonoscopy as a sequential or active choice strategy was found to significantly increase participation in colorectal cancer (CRC) screening, although increased participation in strategies with FIT was not found to lead to higher detection of advanced neoplasia, according to a study in Gastroenterology.
Researchers conducted the multicenter, randomized study (Participation in Competing Strategies for Colorectal Cancer Screening – a Randomized Health Services Study Within the National Screening Program in Poland [PICCOLINO]; ClinicalTrials.gov Identifier: NCT03790475) from January 2019 to March 2020 to determine the best strategy for offering population-wide CRC screening. They invited screening-naive persons to be assigned to 1 of 3 competing strategies: screening colonoscopy only (control); primary colonoscopy and FIT for initial nonresponders (sequential); or choice of colonoscopy or FIT (choice). The primary outcome was participation in CRC screening within 18 weeks after enrollment, and the secondary outcome was diagnostic yield for advanced neoplasia.
Among 12,485 candidates who were eligible for randomization, 4161 were assigned to the control group, 4161 were assigned to the sequential strategy group, and 4163 were assigned to the choice strategy group. After exclusions due to the death of participants and colonoscopy performed in the last 10 years (among other exclusion criteria), 3878 participants remained in the control group, 3908 remained in the sequential strategy group, and 3999 remained in the choice strategy group. Participants’ mean age was 58 years, and 46.7% were men.
The investigators found that the participation rate in the control group (17.5%) was significantly lower compared with the rate in the sequential (25.8%) and choice strategy (26.5%) groups (P < .001 for both comparisons). Colonoscopy rates for participants with a positive FIT were 70.0% for the sequential group and 73.3% for the choice group.
“This pragmatic randomized trial shows that screening strategies [that] combine FIT and colonoscopy can result in 60% to 70% higher participation rates relative to the strategy of offering primary colonoscopy screening alone,” the researchers commented. “In the sequential strategy the majority of participants completed primary screening colonoscopy, whereas in the choice strategy, the majority performed a FIT test. In absolute terms, the increase in participation rates [was] only 8% to 10% points higher, which was insufficient to increase advanced neoplasia detection rates in the intention to screen analysis (1.1%, 1.1%, and 1.2% in the control, choice, and sequential groups, respectively).”
The investigators noted several limitations to their findings. Because screening colonoscopy is offered every 10 years and FIT has to be repeated annually or biennially, the comparison between one-off primary screening colonoscopy and one-off combined strategy could be flawed. In addition, the study was nearly concluded when the coronavirus disease 2019 pandemic began and thus the results may not reflect the current epidemiologic situation in which the need for less-invasive testing is emphasized.
“The advantage of the choice strategy over sequential strategy is that it yielded comparable overall participation rates but with significantly lower proportion of individuals who underwent expensive and resource intensive colonoscopy (8.5% vs 14.9%, respectively, P = .001),” stated the study authors.
Disclosure: Some of the authors reported affiliations with pharmaceutical and medical device companies, and the study was supported in part by Eiken Chemical Co. Ltd. Please see the original reference for a full list of disclosures.
Pilonis ND, Bugajski M, Wieszczy P, et al. Participation in competing strategies for colorectal cancer screening—a randomized health services study (PICCOLINO study. Gastroenterology. Published online December 8, 2020. doi:https://doi.org/10.1053/ j.gastro.2020.11.049