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Original Investigation
May 7, 2019

Effect of a Single Aspirin Dose Prior to Fecal Immunochemical Testing on Test Sensitivity for Detecting Advanced Colorectal Neoplasms: A Randomized Clinical Trial

Author Affiliations
  • 1Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany
  • 2Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany
  • 3German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany
  • 4Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany
  • 5Department of Internal Medicine I, Ulm University, Ulm, Germany
  • 6Practice of Gastroenterology, Dornstadt, Germany
  • 7Practice of Internal Medicine, Ulm, Germany
  • 8Practice of Gastroenterology, Völklingen, Germany
  • 9Practice of Gastroenterology, Leverkusen, Germany
  • 10Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Heidelberg, Germany
JAMA. 2019;321(17):1686-1692. doi:10.1001/jama.2019.4755
Visual Abstract.
Visual Abstract.
Effect of Aspirin Prior to Fecal Immunochemical Testing on Test Sensitivity for Detecting Colorectal Neoplasms
Effect of Aspirin Prior to Fecal Immunochemical Testing on Test Sensitivity for Detecting Colorectal Neoplasms
Key Points

Question  What is the effect of a single oral dose of aspirin prior to fecal immunochemical testing on test sensitivity for detecting advanced colorectal neoplasms?

Findings  In this randomized clinical trial involving 2422 adults aged 40 to 80 years not using aspirin or other antithrombotic medications, there was no statistically significant difference in fecal immunochemical test sensitivity for detecting advanced colorectal neoplasms with administration of a single tablet of 300-mg aspirin, compared with placebo, 2 days before fecal testing (sensitivity at 2 prespecified positivity thresholds: 40.2% vs 30.4%, and 28.6% vs 22.5%, respectively).

Meaning  Administration of a single dose of oral aspirin prior to fecal immunochemical testing, compared with placebo, did not significantly increase test sensitivity for detecting advanced colorectal neoplasms at 2 predefined cutoffs of a quantitative fecal immunochemical test.

Abstract

Importance  Fecal immunochemical tests for hemoglobin are widely used for colorectal cancer (CRC) screening. Observational studies suggested that sensitivity of fecal immunochemical tests for detecting advanced neoplasms could be increased by acetylsalicylic acid (aspirin), especially among men.

Objective  To evaluate the potential to increase sensitivity of fecal immunochemical tests by administering a single 300-mg oral aspirin dose 2 days before stool sampling.

Design, Setting, and Participants  A randomized, placebo-controlled, double-blind trial was conducted in 14 gastroenterology practices and 4 hospitals in Germany, and included 2422 men and women aged 40 to 80 years scheduled for colonoscopy, with no recent use of aspirin or other drugs with antithrombotic effects (enrollment from June 2013 to November 2016, and final follow-up January 27, 2017).

Interventions  Administration of a single tablet containing 300 mg of aspirin (n = 1208) or placebo (n = 1214) 2 days before fecal sampling for fecal immunochemical test.

Main Outcome and Measures  The primary outcome was sensitivity of a quantitative fecal immunochemical test at 2 predefined cutoffs (10.2 and 17-μg Hb/g stool) for detecting advanced neoplasms (colorectal cancer or advanced adenoma).

Results  Among 2422 randomized patients (mean [SD] age, 59.6 [7.9] years; 1219, 50%, men), 2134 were included in the analysis (78% for primary screening colonoscopy, 22% for diagnostic colonoscopy). Advanced neoplasms were identified in 224 participants (10.5%), including 8 participants (0.4%) with CRC and 216 participants (10.1%) with advanced adenoma. Sensitivity was 40.2% in the aspirin group and 30.4% in the placebo group (difference 9.8%, 95% CI, −3.1% to 22.2%, P = .14) at cutoff 10.2-μg Hb/g stool and 28.6% in the aspirin and 22.5% in the placebo group (difference 6.0%, 95% CI, −5.7% to 17.5%, P = .32) at cutoff 17-μg Hb/g stool.

Conclusions and Relevance  Among adults aged 40 to 80 years not using aspirin or other antithrombotic medications, administration of a single dose of oral aspirin prior to fecal immunochemical testing, compared with placebo, did not significantly increase test sensitivity for detecting advanced colorectal neoplasms at 2 predefined cutoffs of a quantitative fecal immunochemical test.

Trial registration  Deutsches Register Klinischer Studien Identifier: DRKS00003252; EudraCT Identifier: 2011-005603-32/DE

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