The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia.
Barrett’s Esophagus
Esophageal Adenocarcinoma
High-Grade Dysplasia
Tissue Systems Pathology test (TSP-9)
TissueCypher
Journal
Gastroenterology
ISSN: 1528-0012
Titre abrégé: Gastroenterology
Pays: United States
ID NLM: 0374630
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
received:
19
10
2022
revised:
10
07
2023
accepted:
12
07
2023
pubmed:
2
9
2023
medline:
2
9
2023
entrez:
1
9
2023
Statut:
ppublish
Résumé
Low-grade dysplasia (LGD) is associated with an increased risk of progression in Barrett's esophagus (BE); however, the diagnosis of LGD is limited by substantial interobserver variability. Multiple studies have shown that an objective tissue systems pathology test (TissueCypher Barrett's Esophagus Test, TSP-9), can effectively predict neoplastic progression in patients with BE. This study aimed to compare the risk stratification performance of the TSP-9 test vs benchmarks of generalist and expert pathology. A blinded cohort study was conducted in the screening cohort of a randomized controlled trial of patients with BE with community-based LGD. Biopsies from the first endoscopy with LGD were assessed by the TSP-9 test and independently reviewed by 30 pathologists from 5 countries per standard practice. The accuracy of the test and the diagnoses in predicting high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) were compared. A total of 154 patients with BE (122 men), mean age 60.9 ± 9.8 years were studied. Twenty-four patients progressed to HGD/EAC within 5 years (median time of 1.7 years) and 130 did not progress to HGD/EAC within 5 years (median 7.8 years follow-up). The TSP-9 test demonstrated higher sensitivity (71% vs mean 63%, range 33%-88% across 30 pathologists), than the pathology review in detecting patients who progressed (P = .01186). The TSP-9 test outperformed the pathologists in risk stratifying patients with BE with LGD. Care guided by the test can provide an effective solution to variable pathology review of LGD, improving health outcomes by upstaging care to therapeutic intervention for patients at high risk for progression, while reducing unnecessary interventions in low-risk patients.
Sections du résumé
BACKGROUND & AIMS
OBJECTIVE
Low-grade dysplasia (LGD) is associated with an increased risk of progression in Barrett's esophagus (BE); however, the diagnosis of LGD is limited by substantial interobserver variability. Multiple studies have shown that an objective tissue systems pathology test (TissueCypher Barrett's Esophagus Test, TSP-9), can effectively predict neoplastic progression in patients with BE. This study aimed to compare the risk stratification performance of the TSP-9 test vs benchmarks of generalist and expert pathology.
METHODS
METHODS
A blinded cohort study was conducted in the screening cohort of a randomized controlled trial of patients with BE with community-based LGD. Biopsies from the first endoscopy with LGD were assessed by the TSP-9 test and independently reviewed by 30 pathologists from 5 countries per standard practice. The accuracy of the test and the diagnoses in predicting high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) were compared.
RESULTS
RESULTS
A total of 154 patients with BE (122 men), mean age 60.9 ± 9.8 years were studied. Twenty-four patients progressed to HGD/EAC within 5 years (median time of 1.7 years) and 130 did not progress to HGD/EAC within 5 years (median 7.8 years follow-up). The TSP-9 test demonstrated higher sensitivity (71% vs mean 63%, range 33%-88% across 30 pathologists), than the pathology review in detecting patients who progressed (P = .01186).
CONCLUSIONS
CONCLUSIONS
The TSP-9 test outperformed the pathologists in risk stratifying patients with BE with LGD. Care guided by the test can provide an effective solution to variable pathology review of LGD, improving health outcomes by upstaging care to therapeutic intervention for patients at high risk for progression, while reducing unnecessary interventions in low-risk patients.
Identifiants
pubmed: 37657759
pii: S0016-5085(23)04960-0
doi: 10.1053/j.gastro.2023.07.029
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1168-1179.e6Investigateurs
John Goldblum
(J)
Elizabeth Montgomery
(E)
Jon Davison
(J)
Jagjit Singh
(J)
Jared Szymanski
(J)
Anthony Perry
(A)
Kees Seldenrijk
(K)
Fiebo Ten Kate
(FT)
G Johan A Offerhaus
(GJA)
Paul Drillenberg
(P)
Casper Jansen
(C)
Natalja Leeuwis-Fedorovic
(N)
Runjan Chetty
(R)
Roger Feakins
(R)
Marnix Jansen
(M)
Catherine Chinyama
(C)
Edwin Cooper
(E)
Reza Vaziri
(R)
Gustavo Baretton
(G)
Andrea Tannapfel
(A)
Michael Vieth
(M)
Balint Melcher
(B)
Ildiko Mesteri
(I)
Heiko Müller
(H)
Philipp Wetzel
(P)
Gert de Hertogh
(G)
Anne Hoorens
(A)
Stepanie Verschuere
(S)
An Tamsin
(A)
Kevin Wetzels
(K)
Marie-Astrid van Caillie
(MV)
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.