Prognostic tool may identify those with BE at higher risk for developing esophageal cancer
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Key takeaways:
- The odds of disease progression were 6.4-times higher among patients categorized as higher risk via Esopredict.
- The assay may provide critical information to guide treatment decisions for patients with BE.
The biomarker-based Esopredict determined that patients with Barrett’s esophagus who were stratified as higher risk were 6.4-times more likely to progress to high-grade dysplasia or esophageal adenocarcinoma within 5 years, research showed.
“Esopredict is a prognostic assay based on DNA methylation levels that stratifies future progression risk in BE patients using biopsies already obtained during surveillance EGD,” Sarah E. Laun, PhD, vice president of research and development at Previse, and colleagues wrote in The American Journal of Gastroenterology, noting that Esopredict incorporates age plus four key, previously validated biomarkers.
They continued: “This assay measures the level of methylation changes of each biomarker which often occurs early, before significant shifts in clinical phenotype, which is an important advantage for early detection and prognostication.”
In a retrospective, case-control study designed to clinically validate Esopredict in determining risk for disease progression, Laun and colleagues collected biopsies from 240 patients with BE at six U.S. medical sites between May 2021 and January 2023.
The researchers included 209 eligible patients, who had a histological diagnosis of nondysplastic or indefinite or low-grade dysplastic BE, and divided them into testing (n = 99) and validation (n = 110) cohorts. Of these, 78 patients progressed to high-grade dysplasia or esophageal adenocarcinoma within 5 years and 131 did not progress in 5 years or more. They also independently tested a cohort of 31 patients who progressed at time intervals exceeding 5 years.
According to analysis, the area under the ROC curve for predicting disease progression was 0.76 and 0.73 in the training and validation cohorts, respectively. The odds of progression within 5 years were 6.4-times higher among patients stratified as higher risk vs. lower risk via Esopredict.
After further stratifying patients into four risk levels, the researchers reported the low-risk group had a four times below-average risk for progression (1.85%) and the low to moderate-risk group had a slightly lower than average risk (4.47%). Conversely, those in the high to moderate-risk and high-risk groups had a slightly higher than average risk (8.12%) and a “more than four times” above average risk (21.46%) for progression, respectively.
Overall, high-risk patients were 15.2-times more likely to progress to high-grade dysplasia or esophageal adenocarcinoma within 5 years vs. low-risk patients.
“Esopredict provides critical information for guiding preventative treatment decisions,” Laun and colleagues wrote. “Clinicians will be able to use Esopredict’s risk-stratification system with an individualized probability of progression score to determine the most appropriate management for their patients with BE, to either lengthen future endoscopic surveillance intervals and avoid endoscopic eradication therapies (low risk), build confidence around current care management (low-moderate risk) or consider increasing surveillance or endoscopic eradication therapies to prevent the development of one of the most lethal cancers in patients at higher risk.”
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