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What is the effect of a single oral dose of aspirin prior to fecal immunochemical testing on test sensitivity for detecting advanced colorectal neoplasms?
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).
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.
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.
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).
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).
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.
Deutsches Register Klinischer Studien Identifier: DRKS00003252; EudraCT Identifier: 2011-005603-32/DE
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Corresponding Author: Hermann Brenner, MD, MPH, Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Im Neuenheimer Feld 581, 69120 Heidelberg, Germany (email@example.com)
Accepted for Publication: March 29, 2019.
Author Contributions: Drs Brenner and Calderazzo had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Czock and Tikk contributed equally.
Concept and design: Brenner, Czock, Tikk.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Brenner.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Calderazzo, Kopp-Schneider.
Obtained funding: Brenner.
Administrative, technical, or material support: Seufferlein, Ludwig, Dikopoulos, Stolz, Eisenbach, Block, Tikk.
Supervision: Brenner, Block, Czock.
Conflict of Interest Disclosures: Dr Brenner reported receiving grants from the German Federal Ministry of Education and Research, the German Cancer Aid, the European Commission, the US National Institutes of Health, Applied Proteomics, Roche Diagnostics, Volition, and Goodgut during the conduct of the study. Dr Calderazzo reported receiving grants from the German Federal Ministry of Education and Research and Deutsche Forschungsgemeinschaft during the conduct of the study. Dr Seufferlein reported receiving grants and personal fees from Celgene and Sanofi-Genzyme; personal fees from Roche, Bayer, Merck-Serono, and Novartis; and grants from Amgen and Boehringer Ingelheim outside the submitted work. Dr Kopp-Schneider reported receiving grants from the Deutsche Forschungsgemeinschaft and the German Federal Ministry of Education and Research during the conduct of the study. No other disclosures were reported.
Funding/Support: The ASTER trial was conducted in the context of the German Cancer Consortium (DKTK), funded by the German Federal Ministry of Education and Research.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank all the gastroenterology practices and clinics for their excellent cooperation in patient recruitment and the Labor Limbach (Heidelberg, Germany) for the analyses of the quantitative fecal immunochemical test. We thank the Coordinating Center for Clinical Trials (University of Heidelberg, Heidelberg, Germany) for its great support during the whole trial. We also thank Katarina Cuk, PhD, Romana Kimmel, Sabine Eichenherr, and Ulrike Schlesselmann (Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany) for their excellent work in the laboratory and Jason Hochhaus, Utz Benscheid, PhD, and Natalia Zumkeller, MD (Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany) for their contribution in data collection, monitoring, and documentation. These organizations and individuals were compensated for their contributions.
Data Sharing Statement: See Supplement 4.
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