The Colorectal Cancer-Adenoma Incidence and Mortality (CRC-AIM) model is a microsimulation model based on the Cancer Intervention and Surveillance Modeling Network (CISNET) model and Colorectal Cancer-Simulated Population model for Incidence and Natural history (CRC-SPIN) and includes natural history and colorectal cancer (CRC) screening components.1 CRC-AIM has been cross-validated against CISNET models.1 Predicted outcomes were simulated for 4 million individuals born in 1975 who were undiagnosed with CRC at age 40 and screened between ages 45–75 years or 50–75 years.1
At real-world adherence rates, multi-target stool DNA (mt-sDNA) resulted in an 8.4% to 19.1% increase in the number of life-years gained (LYG) compared with fecal immunochemical test (FIT) for screening ages 50-75 years, with similar results for ages 45-75 years1
At equivalent numbers of completed tests over the screening window, mt-sDNA resulted in greater LYG and reductions in CRC-related mortality and incidence compared with FIT2
With a 12, 18, and 24-month screening delay, reduction in CRC-related incidence and mortality and increase in LYG was greater with triennial mt-sDNA than annual FIT3
ESTIMATING THE IMPACT OF IMPERFECT ADHERENCE TO STOOL-BASED COLORECTAL CANCER SCREENING STRATEGIES ON COMPARATIVE EFFECTIVENESS USING THE CRC-AIM MODEL1,a
- At real-world adherence rates of 71%b for mt-sDNA4 and 40-50% for FIT,5,6 mt-sDNA resulted in an 8.4 to 19.1% increase in the number of LYG compared with FIT for screening ages 50-75 years. Similar results were observed for screening ages 45-75 years
- At imperfect adherence rates in individuals screened between ages 50–75 or 45–75, the reduction in CRC-related incidence and mortality was higher for mt-sDNA than FIT (at 70% vs 40-50% real-world adherence rates, respectively)
- At equivalent adherence rates, mt-sDNA resulted in a higher number of total required colonoscopies and a lower number of tests per 1000 individuals compared with FIT
MICROSIMULATION STUDY OF LIFE-YEARS GAINED FROM SCREENING VERSUS FOLLOW-UP COLONOSCOPY USING THE CRC-AIM MODEL7
The estimated LYG/colonoscopy was ~3x higher overall in patients ages 50-75, and ~5x in ages 65-75 for procedures performed in follow-up of a positive stool-based screening test vs colonoscopy performed for a screening indication
MORE FIT TESTS WERE NEEDED TO MATCH THE CLINICAL BENEFIT OF EQUIVALENT NUMBERS OF mt-sDNA TESTS2
| LYG & CRC Incidence/Mortality Reduction by Screening Strategy | |||
| Screening Strategy | Randomly Assigned Number of Tests | CRC Incidence Reduction | CRC Mortality Reduction |
| mt-sDNA, 50-75 | Up to 1 | 15.5% | 19.4% |
| FIT, 50-75 | Up to 1 | 8.2% | 11.3% |
| mt-sDNA, 50-75 | Up to 5 | 48.7% | 56.9% |
| FIT, 50-75 | Up to 5 | 30.6% | 39.1% |
| mt-sDNA, 50-75 | Up to 9 | 63.4% | 71.3% |
| FIT, 50-75 | Up to 9 | 43.8% | 53.3% |
- The reductions in CRC-related incidence and CRC-related mortality were greater with up to 1, up to 5, or up to 9 mt- sDNA tests compared with equivalent numbers of FIT tests
- At equivalent numbers of completed tests over the screening window, mt-sDNA resulted in greater LYG, reductions in CRC-related mortality and incidence compared with FIT
Learn more about the full Indications/Contraindications for the mt-sDNA test.
Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure
References
1 Piscitello A, Saoud L, Fendrick AM, et al. Estimating the impact of differential adherence to stool-based colorectal cancer screening strategies on comparative effectiveness using the CRC-AIM microsimulation model. PLoS One. 2020;15(12):e0244431.
2 Saoud L, Fendrick AM, Piscitello A, et al. More fecal immunochemical tests are needed to match the clinical benefit of equivalent numbers of multitarget stool DNA tests. Gastroenterol. 2020;158(6):S642-S643.
3 Limburg P, Saoud L, Borah B, et al. Higher impact on clinical outcomes from delays in colorectal cancer screening with the fecal immunochemical test vs multitarget stool DNA: CRC-AIM microsimulation model results. Gastroenterol. 2020;158(6):S-1176.
4 Weiser E, Parks PD, Swartz RK, et al. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: Real-world data from a large cohort of older adults. J Med Screen. 2021;28(1):18-24.
5 Hassan C, Rigori Rossi PG, Camilloni L, et al. Meta-analysis: adherence to colorectal cancer screening and the detection rate for advanced neoplasia, according to the type of screening test. Aliment Pharmacol Ther. 2012;36:929-940.
6 Jensen CD, Corley DA, Quinn VP, et al. Fecal immunochemical test program performance over 4 rounds of annual screening: A retrospective cohort study. Ann Intern Med. 2016;164(7):456-463.
7 Fendrick AM, Piscitello A, Borah B, et al. Microsimulation study of life-years gained from screening versus follow-up colonoscopy using the CRC-AIM Model. Gastroenterol. 2020;158(6):S372.
Footnotes
a Assumptions: All CRC screening test performance assumptions (sensitivity, specificity, and complications) were intentionally unchanged from the CISNET modeling analyses used to inform recent guideline recommendations. CRC microsimulation models used to inform CRC screening guidelines assume perfect (100%) adherence with all CRC screening, follow-up, and surveillance procedures over each individual’s lifetime. Adherence was set by assuming a fixed annual likelihood to comply with each stool-based screening strategy ranging from 0% to 100%, in 10% increments. It was assumed that patients were offered a stool-based screening test yearly unless they were not due for screening. Real-world first-round differential adherence rates of 40%–50% for annual fecal immunochemical test (FIT) and 70% for triennial multitarget stool DNA (mt-sDNA) were considered likely imperfect rates. Limitations: None reported.
b 71% mt-sDNA adherence rate in Medicare Beneficiaries cohort.
c Assumptions: All CRC screening test performance assumptions (sensitivity, specificity, and complications) were intentionally unchanged from the CISNET modeling analyses used to inform recent guideline recommendations. Assumed that recommended triennial mt-sDNA or annual FIT was delayed by 12, 18, or 24 months every time screening was due. For example, with a 12-month delay for triennial mt-sDNA, an individual would complete their first test at age 51 instead of 50 and their second test at age 55 instead of 53 (age 51 + 3-year interval + 12 months delay=age 55). Limitations: None reported.
d Assumptions: All CRC screening test performance assumptions (sensitivity, specificity, and complications) were intentionally unchanged from the CISNET modeling analyses used to inform recent guideline recommendations. Limitations: Only average-risk screening colonoscopies and follow-up colonoscopies after a positive mt-sDNA or FIT test were taken into account, with no surveillance colonoscopies for the primary analysis.
e Assumptions: All CRC screening test performance assumptions (sensitivity, specificity, and complications) were intentionally unchanged from the CISNET modeling analyses used to inform recent guideline recommendations. The CISNET model-derived acceptable threshold for incremental ratios (ΔCOL/ ΔLYG) for a 10-year benchmark colonoscopy when the screening window is 50–75 is between 39-653. Limitations: None reported.
Last updated: 04/22/2023