@article{46d816b0bd164f8fb505f82a93d3a138,
title = "Durability of radiofrequency ablation in Barrett's esophagus with dysplasia",
abstract = "Background & Aims: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE. Methods: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events. Results: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). KaplanMeier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years). Conclusions: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.",
keywords = "Cancer, Endoscopic Therapy, Esophagus, Prevention",
author = "Shaheen, {Nicholas J.} and Overholt, {Bergein F.} and Sampliner, {Richard E.} and Wolfsen, {Herbert C.} and Wang, {Kenneth K.} and Fleischer, {David E.} and Sharma, {Virender K.} and Eisen, {Glenn M.} and Fennerty, {M. Brian} and Hunter, {John G.} and Bronner, {Mary P.} and Goldblum, {John R.} and Bennett, {Ana E.} and Hiroshi Mashimo and Rothstein, {Richard I.} and Gordon, {Stuart R.} and Edmundowicz, {Steven A.} and Madanick, {Ryan D.} and Peery, {Anne F.} and Muthusamy, {V. Raman} and Chang, {Kenneth J.} and Kimmey, {Michael B.} and Spechler, {Stuart J.} and Siddiqui, {Ali A.} and Souza, {Rhonda F.} and Anthony Infantolino and Dumot, {John A.} and Falk, {Gary W.} and Galanko, {Joseph A.} and Jobe, {Blair A.} and Hawes, {Robert H.} and Hoffman, {Brenda J.} and Prateek Sharma and Amitabh Chak and Lightdale, {Charles J.}",
note = "Funding Information: Funding This study was supported by funding from B{\^A}RRX Medical, Inc. Study medication was provided through the investigator-sponsored study program of AstraZeneca. Statistical analysis and data management were supported by NIH P30 DK034987. Funding Information: Conflicts of interest The authors disclose the following: Drs Chang and Lightdale received additional grant support from B{\^A}RRX Medical . Drs Chang, Infantolino, and Lightdale received consulting fees from B{\^A}RRX Medical. Drs Chang, Edmundowicz, Infantolino, Madanick, Muthasamy, and Overholt received lecture fees from B{\^A}RRX Medical. Dr Chang has equity ownership in B{\^A}RRX Medical and received consulting fees from B{\^A}RRX Medical and royalties from the B{\^A}RRX Medical Halo 90 device. Drs Eisen, Falk, Hoffman, Shaheen, Spechler, and Souza received grant support from AstraZeneca . Drs Eisen, Falk, Fennerty, Infantolino, Lightdale, Shaheen, Sharma, Souza, and Spechler received consulting fees from AstraZeneca. Drs Eisen, Falk, Infantolino, Madanick, and Shaheen received lecture fees from AstraZeneca. Dr Edmundowicz received consulting fees from Boston Scientific. Dr Eisen received consulting fees from Pfizer and lecture fees from Takeda. Drs Eisen, Shaheen, and Spechler received grant support from Takeda . Drs Edmundowicz and Falk received consulting fees from Olympus. Drs Eisen and Hoffman received lecture fees from Given Imaging. Dr Falk received consulting fees from Nycomed and Ethicon Endosurgery. Drs Falk and Sharma report receiving grant support from Given Imaging . Dr Fennerty received consulting fees from Novartis and Merck. Dr Hoffman received grant support from Bristol Myers Squibb , Salix , Lantheus Medical Imaging , and Otsuka Medical Research . Drs Fennerty, Infantolino, and Sharma received consulting fees from Santarus. Dr Infantolino received lecture fees from Santarus, Abbott, UCB, Centocor, and CSA Medical. Dr Infantolino also received consulting fees from Abbott, UCB, and Centocor. Drs Infantolino and Shaheen received consulting fees from CSA Medical. Dr Shaheen received consulting fees from NeoGenomics. Dr Lightdale received grant support from Boston Scientific . Drs Sampliner, Shaheen, Sharma, Souza, and Spechler received consulting fees from TAP/Takeda. Dr Shaheen received grant support from CSA Medical and NeoGenomics . Dr Sharma received grant support from Olympus . Dr Jobe received grant support from EndoGastric Solutions . The remaining authors disclose no conflicts. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",
year = "2011",
month = aug,
doi = "10.1053/j.gastro.2011.04.061",
language = "English (US)",
volume = "141",
pages = "460--468",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "2",
}