New Assay Predicts Cancer Risk in Barrett’s Esophagus

TOPLINE:

A new epigenetic assay is able to stratify patients with Barrett’s esophagus into lower-risk and higher-risk categories for progression to high-grade dysplasia or esophageal adenocarcinoma within 5 years, aiding in clinical decision-making.

METHODOLOGY:

• Researchers aimed to validate Esopredict (Previse), a polymerase chain reaction–based laboratory test that considers DNA methylation levels of four biomarkers, along with age, to predict the risk for progression in patients with Barrett’s esophagus.
• For this case-control study, researchers collected existing biopsies from 240 patients who were diagnosed with Barrett’s esophagus and no or low-grade dysplasia or were identified as indefinite for dysplasia. Follow-up histologic results were required for all patients, who were selected from six participating US sites.
• Data of the first 99 patients were used in the training set, and those of the next 110 patients were used in the validation set.
• Patients were categorized as progressors if they developed high-grade dysplasia or esophageal adenocarcinoma within 5 years and as nonprogressors if they did not. The algorithm also was tested in an additional cohort of 31 progressors who progressed at time intervals greater than 5 years.
• Cut points were established to determine if patients had a lower-than-average risk (low and low moderate) or higher-than-average risk (high and high moderate) for progression on the basis of prevalence.

TAKEAWAY:

• Patients categorized in the two higher-than-average risk categories (high and high moderate) by the assay were 6.4 times more likely to progress to high-grade dysplasia or esophageal adenocarcinoma within 5 years than those in the two lower-than-average risk categories (low and low moderate).
• An analysis across all four risk subcategories found that patients in the high-risk category were 15.2 times more likely to progress to high-grade dysplasia or esophageal adenocarcinoma than those in the low-risk category.
• The higher-than-average risk category had a greater percentage of progressors, whereas the lower-than-average risk category had a greater percentage of nonprogressors.
• The predictive performance of the assay in the additional set of 31 patients who progressed at time intervals greater than 5 years was comparable to its performance in those with follow-up within 5 years.

IN PRACTICE:

“An advantage of the Esopredict assay is that it adds complementary value to the current standard of care, incorporating epigenetic data without the need for additional biopsies to advance the personalized management of patients with BE [Barrett’s esophagus]. More patients who are high risk and would benefit from preventative EET [endoscopic eradication therapies] or increased surveillance can be identified beyond the current method, while reducing biopsies in patients at low risk for progression,” the authors wrote.

SOURCE:

The study, led by Sarah E. Laun, PhD, Previse, Baltimore, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

One limitation is that instead of a central pathology review, the study relied on the pathologic diagnosis from each clinical center, which could result in variability in histologic diagnosis. The relatively small sample size of patients comprising those with index biopsies of low-grade dysplasia or those identified as indefinite for dysplasia, as well as the predominance of Caucasian patients, may have limited the generalizability of the findings.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. Some authors reported being paid employees, paid consultants, and/or equity holders of Previse and/or inventors of Esopredict.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.