ORLANDO — Early findings from the Aspirin Esomeprazole Chemoprevention Trial indicate that therapy with aspirin and esomeprazole is safe and well tolerated for preventing the progression of Barrett's esophagus to adenocarcinoma.
Since the start of the randomized Aspirin Esomeprazole Chemoprevention Trial (AspECT) in September 2005, 1,192 (83%) of the 1,436 patients have remained on their medication, and just 33 adverse events have been reported, said lead investigator Dr. Janusz Jankowski, professor of medicine, Oxford University (England), at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.
AspECT is an ambitious, 10-year clinical trial being conducted in the United Kingdom. The trial's primary aim is to determine whether treatment with the proton pump inhibitor esomeprazole (Nexium, AstraZeneca) and aspirin can stop Barrett's metaplasia from progressing to adenocarcinoma. The investigators are also trying to determine whether this therapy will prevent or reduce myocardial infarction.
The United Kingdom is fertile ground for such a study, Dr. Jankowski said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.
“The U.K. has the highest incidence of esophageal adenocarcinoma in the world—up to four times greater than that of other countries in Europe,” he said in an interview.
Being able to show that aspirin “is incredibly well tolerated” is very gratifying, Dr. Jankowski said, because many people were skeptical that it could be done. “People thought we were mad and dangerous, and that we would kill patients with low-dose aspirin.”
The first planned efficacy analysis is scheduled for 2010, and the final analysis is due in 2016. The trial is funded by Cancer Research UK, Oxford University, and AstraZeneca. Dr. Jankowski disclosed that he is a consultant to and receives research funding from AstraZeneca.