An updated analysis of a randomized phase III trial showed that taking a high dose of esomeprazole with low-dose aspirin for at least 7 years may moderately reduce the risk of developing high-grade dysplasia or esophageal cancer and may delay death from any cause in people with Barrett’s esophagus. The findings were featured in a press briefing and presented by Janusz Jankowski, MD, PhD, Deputy Vice Chancellor, Royal College of Surgeons, Ireland, and Consultant Clinical Adviser, National Institute for Health and Care Excellence, United Kingdom, at the 2018 ASCO Annual Meeting.1
Janusz Jankowski, MD, PhD
The authors estimate that development of these adverse outcomes could be delayed by using these medicines, both available without prescription, but emphasize patients with Barrett’s esophagus should speak to their doctor’s first. “Based on these data, we believe people with heartburn should talk with their doctor about their risk of Barrett’s esophagus, but they should not self-medicate with these medications,” said Dr. Jankowski.
The ASPECT trial randomly assigned 2,563 people with Barrett’s esophagus to 4 treatment groups: high-dose proton pump inhibitor esomeprazole; high-dose esomeprazole with low-dose aspirin; standard-dose (eg, low-dose) esomeprazole, or standard-dose (eg, low-dose) esomeprazole with low-dose aspirin. The primary endpoint was time to death from any cause, diagnosis of esophageal cancer, or diagnosis of high-grade dysplasia. The analysis was adjusted for patient age and duration of Barrett’s esophagus.
Patients were followed for a median of 8.9 years, and high-dose esomeprazole had a statistically significant benefit on the combined endpoint compared to standard-dose esomeprazole (P = .05). The most effective treatment was high-dose esomeprazole with low-dose aspirin.
“The risk of esophageal cancer weighs on patients with Barrett’s esophagus. For these patients, this regimen reduces serious complications of acid reflux disease and the risk of dying from all causes, including esophageal cancer, and with little to no side effects. It’s an approach that people with Barrett’s should consider and discuss with their doctors,” said ASCO expert Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York.
The treatments were safe overall, with serious side effects reported in 1% of patients. The most common side effect of proton pump inhibitors is diarrhea. People with heart disease should be aware that these drugs can interact with various heart medications. Other, much rarer risks include Clostridium difficile infection and osteoporosis.
The most serious side effects of aspirin include allergic reactions, bleeding in the stomach, and bleeding in the brain (particularly for people with hypertension). In addition, people who are already taking another nonsteroidal anti-inflammatory drug should not be taking aspirin.
This was reportedly the largest chemoprevention randomized controlled trial in Barrett’s esophagus and it had the longest follow-up, but more research is needed, noted Dr. Jankowski. The research was conducted in five countries with mostly white populations, so it is not known whether this chemoprevention strategy would be as effective in black and Asian patients, as genetic ancestry can affect treatment efficacy. In addition, the researchers would like to follow patients on this study to see whether 9 to 10 years of chemoprevention is even more effective and whether there is an increased risk for side effects with longer treatment. ■
DISCLOSURE: Dr. Jankowski has received honoraria from Takeda and research funding from AstraZeneca. Dr. Epstein reported no conflicts of interest.
1. Jankowski J, et al: Chemoprevention of esophageal cancer with esomeprazole and aspirin therapy. 2018 ASCO Annual Meeting. Abstract LBA4008. Presented June 4, 2018.