article213

COLONPREV

"Comparative Effectiveness of Colonoscopy vs Fecal Immunochemical Testing for Colorectal Cancer Screening".The New England Journal of Medicine. Date undisclosed.PubMed•ClinicalTrials.gov•PDF

Clinical Question

Does fecal immunochemical testing (FIT) every 2 years have a similar effectiveness compared to one-time colonoscopy in colorectal cancer screening among average-risk adults?

Bottom Line

In a randomized controlled trial, FIT was found to have higher participation rates and the detection of colorectal cancer was similar for FIT every 2 years and one-time colonoscopy screening, although more adenomas were identified with colonoscopy.

Major Points

Colorectal cancer screening can improve outcomes but the relative benefits of different strategies, such as FIT versus colonoscopy, are debated. This trial compared participation rates, diagnostic findings, and major complications between one-time colonoscopy and FIT every 2 years for colorectal cancer screening.

Guidelines

Current guidelines vary, but generally include both FIT and colonoscopy as acceptable colorectal cancer screening strategies.

Design

- Multicenter, randomized, controlled, noninferiority trial
- N=53,302 adults (26,703 colonoscopy, 26,599 FIT)
- Setting: 8 Spanish regions
- Enrollment: 2008-2011
- Analysis: Intention-to-treat and as-screened
- Primary outcome: Death from colorectal cancer at 10 years

Population

- Inclusion Criteria: Asymptomatic adults aged 50-69 years
- Exclusion Criteria: History of colorectal cancer, adenoma, inflammatory bowel disease, significant family history of colorectal cancer, severe concurrent illness, previous colectomy
- Baseline Characteristics: Similar mean age (~59 years) and gender distribution (women 53.5% colonoscopy, 54.3% FIT)

Interventions

- One-time colonoscopy group or FIT every 2 years group

Outcomes

- Primary Outcome: Participation rates higher in FIT group than colonoscopy (34.2% vs. 24.6%)
- Secondary Outcomes: Similar detection rates of colorectal cancer (0.1% in both); more adenomas detected in colonoscopy group (advanced adenomas 1.9% vs. 0.9%; nonadvanced adenomas 4.2% vs. 0.4%)
- Additional Analyses: No significant difference in cancer tumor stage detection; superior diagnostic yield of colonoscopy for both advanced and nonadvanced adenomas, particularly in proximal colon
- Adverse Events: Major complications higher in colonoscopy group (0.5% vs. 0.1%)

Criticisms

- Generalizability is limited due to varying participation rates geographically.
- Lower than expected participation rates compared to other screening programs.

Funding

Supported by grants from national and regional health authorities in Spain; FIT supplies and analyzers donated by Eiken Chemical, Palex Medical, and Biogen Diagnóstica.