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Aspirin Plus PPI Prevents Esophageal Cancer.

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Combined use of aspirin and a high-dose proton pump inhibitor (PPI) protects against the development of esophageal cancer in people who are at elevated risk for the malignancy, according to the results of a major phase 3 chemoprevention trial from the United Kingdom, the Aspirin and Esomeprazole Chemoprevention in Barrett’s Metaplasia (AspECT) trial.

Dr Janusz Jankowski

However, as the trial continues, there are looming risks from the ongoing use of aspirin in aging study participants. These risks may negate the survival benefit that has been demonstrated in the trial, principal investigator Janusz Jankowski, MD, of the Royal College of Surgeons, Ireland.

The magnitude of the overall benefits seen in the trial were “surprising” and were greater than expected, said Jankowski while discussing the results with reporters during a press conference here at the American Society of Clinical Oncology (ASCO) 2018 annual meeting.

Before enrollment, 2563 of the study patients already had Barrett’s esophagus, which increases the risk for esophageal cancer and is predominantly caused by acid reflux.

Notably, the study participants were already taking a PPI (esomeprazole [multiple brands]) for Barrett’s when they were recruited into the trial during otherwise routine physician office visits at 85 centers in the United Kingdom.

The trial, which began in 2003, uses a 2×2 randomized design to assign participants to one of four study groups:

High-dose esomeprazole (80 mg daily)

High-dose esomeprazole with low-dose aspirin (300 mg daily)

Low-dose esomeprazole (40 mg daily)

Low-dose esomeprazole with low-dose aspirin

A placebo control was not used because it was considered unethical to withhold a PPI in the trial, Jankowski explained. Aspirin was included for its anti-inflammatory effect.

The primary endpoint was a composite of three events (and the related time to their occurrence): death from any cause; diagnosis of esophageal adenocarcinoma or diagnosis of high-grade dysplasia; a high-risk precancerous condition.

The composite endpoint was necessary because only 2% to 3% of patients with Barrett’s esophagus subsequently develop esophageal cancer, said Jankowski.

The median follow-up was 8.9 years. The investigators report that there was a 27% delay in the time to the composite endpoint with high-dose vs low-dose esomeprazole (P = .037).

The investigators also report that there was no significant difference for the composite endpoint between aspirin vs no aspirin, said Jankowski. However, when the investigators censored some patients for use of other nonsteroidal anti-inflammatory drugs outside the protocol, there appeared to be some benefit. “The benefit from aspirin seems borderline,” he summarized.

GDMeds, an India Pharmacy Service company

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