May 07, 2019
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Single-dose aspirin fails to improve FIT results

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A single dose of aspirin did not help improve the sensitivity of fecal immunochemical testing for adults undergoing colorectal cancer screening, according to a study published in JAMA.

Hermann Brenner, MD, MPH, of the division of clinical epidemiology and aging research at the German Cancer Research Center, and colleagues wrote that a previous observational study found that low-dose aspirin helped enhance sensitivity of FITs for detecting advanced adenomas, and they wanted to expand this research into a randomized, controlled trial.

“A plausible explanation might be that aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT,” they wrote. “This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity.”

Researchers conducted the trial at 14 gastroenterology practices and four hospitals in Germany. They recruited 2,422 patients aged 40 to 80 years who were scheduled for colonoscopy and had no recent use of aspirin or other drugs with antithrombotic effects.

Investigators randomly assigned patients to receive either a single tablet containing 300 mg of aspirin (n = 1,208) or placebo (n = 1,214) two days before fecal sampling for FIT. After follow-up, they included 2,134 patients in their analysis.

Brenner and colleagues identified advanced neoplasms in 224 patients (10.5%), including 8 with CRC (0.4%) and 216 with advanced adenomas (10.5%).

Researchers determined that the sensitivity in the aspirin group was 40.2% compared with 30.4% in the placebo group (difference 9.8%; 95% CI, –3.1% to 22.2%, P = .14) when the cutoff was 10.2 µg HB/g stool. When they changed the cutoff to 17 µg HB/g stool, they found that the sensitivity in the aspirin group was 28.6% compared with 22.5% in the placebo group (6%; 95% CI, –5.7% to 17.5%).

Although the trial did not support their original hypothesis, Brenner and colleagues wrote that their findings still leave room for further exploration.

“Taken together, results from these observational studies and this trial suggest that further research is needed to assess whether low-dose aspirin may have an effect on FIT test performance, such as in a larger well-powered trial,” they wrote. “This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems.” – by Alex Young

Disclosures: Brenner reports receiving grants from Applied Proteomics, the European Commission, the German Cancer Aid, the German Federal Ministry of Education and Research, Goodgut, Roche Diagnostics, the United States National Institutes of Health and Volition. Please see the full study for all other authors’ relevant financial disclosures.