Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial

Cancer research · Colorectal cancer

The SCREESCO trial found that primary colonoscopy and FIT screening increase the detection of stage I–II colorectal cancer—indicating a screening benefit—while also raising early‑phase adverse events, underscoring an initial harm.

There is a need to quantify the benefits and harms of colorectal cancer (CRC) screening using primary colonoscopy or fecal immunochemical testing (FIT) compared with usual care with no screening. Guidelines recommend screening in individuals aged 50–75 years using colonoscopy or FIT, and many screening programs use one‑sample biennial FIT. Here we compare incidence of diagnosed CRCs and gastrointestinal and cardiovascular events between screening and usual care during the diagnostic phase of the SCREESCO trial. A randomized block method (no masking) assigned 278,280 individuals aged 60 years to once‑only colonoscopy, 2 rounds of two‑stool FIT with a low cutoff (10 µg g−1 feces) or usual care (control group) in a ratio of 1:6 for colonoscopy versus control and 1:2 for FIT versus control. After a median follow‐up of 4.8 years, the incidence rate of CRC was 107.9 in the colonoscopy arm and 99.9 in controls per 100,000 person‑years (IRR 1.08, 95% CI 0.91–1.28) and 96.0 in the FIT arm and 103.9 in controls (IRR 0.92, 95% CI 0.81–1.05). Rates of stage I–II CRC were higher in the colonoscopy arm (IRR 1.38, 95% CI 1.09–1.74) and in the FIT arm (IRR 1.19, 95% CI 0.99–1.43) versus controls. Rates of cardiovascular and gastrointestinal events were slightly higher in the intervention arms during the first year and were subsequently more similar to controls.

The study demonstrates that screening with colonoscopy or FIT increases early‑stage CRC detection, supporting current screening guidelines. It also highlights a modest rise in short‑term adverse events, informing risk–benefit discussions for clinicians and patients.

Evidence level: Megerősített klinikai bizonyíték. Több vagy erősebb humán vizsgálat támogatja.

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