Durability of radiofrequency ablation in Barrett's esophagus with dysplasia

Nicholas J. Shaheen; Bergein F. Overholt; Richard E. Sampliner; Herbert C. Wolfsen; Kenneth K. Wang; David E. Fleischer; Virender K. Sharma; Glenn M. Eisen; M. Brian Fennerty; John G. Hunter; Mary P. Bronner; John R. Goldblum; Ana E. Bennett; Hiroshi Mashimo; Richard I. Rothstein; Stuart R. Gordon; Steven A. Edmundowicz; Ryan D. Madanick; Anne F. Peery; V. Raman Muthusamy; Kenneth J. Chang; Michael B. Kimmey; Stuart J. Spechler; Ali A. Siddiqui; Rhonda F. Souza; Anthony Infantolino; John A. Dumot; Gary W. Falk; Joseph A. Galanko; Blair A. Jobe; Robert H. Hawes; Brenda J. Hoffman; Prateek Sharma; Amitabh Chak; Charles J. Lightdale

doi:10.1053/j.gastro.2011.04.061

Durability of radiofrequency ablation in Barrett's esophagus with dysplasia

Nicholas J. Shaheen, Bergein F. Overholt, Richard E. Sampliner, Herbert C. Wolfsen, Kenneth K. Wang, David E. Fleischer, Virender K. Sharma, Glenn M. Eisen, M. Brian Fennerty, John G. Hunter, Mary P. Bronner, John R. Goldblum, Ana E. Bennett, Hiroshi Mashimo, Richard I. Rothstein, Stuart R. Gordon, Steven A. Edmundowicz, Ryan D. Madanick, Anne F. Peery, V. Raman MuthusamyKenneth J. Chang, Michael B. Kimmey, Stuart J. Spechler, Ali A. Siddiqui, Rhonda F. Souza, Anthony Infantolino, John A. Dumot, Gary W. Falk, Joseph A. Galanko, Blair A. Jobe, Robert H. Hawes, Brenda J. Hoffman, Prateek Sharma, Amitabh Chak, Charles J. Lightdale

Research output: Contribution to journal › Article › peer-review

390 Scopus citations

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.

Original language	English (US)
Pages (from-to)	460-468
Number of pages	9
Journal	Gastroenterology
Volume	141
Issue number	2
DOIs	https://doi.org/10.1053/j.gastro.2011.04.061
State	Published - Aug 2011

Keywords

Cancer
Endoscopic Therapy
Esophagus
Prevention

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2011.04.061

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Shaheen, N. J., Overholt, B. F., Sampliner, R. E., Wolfsen, H. C., Wang, K. K., Fleischer, D. E., Sharma, V. K., Eisen, G. M., Fennerty, M. B., Hunter, J. G., Bronner, M. P., Goldblum, J. R., Bennett, A. E., Mashimo, H., Rothstein, R. I., Gordon, S. R., Edmundowicz, S. A., Madanick, R. D., Peery, A. F., ... Lightdale, C. J. (2011). Durability of radiofrequency ablation in Barrett's esophagus with dysplasia. Gastroenterology, 141(2), 460-468. https://doi.org/10.1053/j.gastro.2011.04.061

Shaheen, NJ, Overholt, BF, Sampliner, RE, Wolfsen, HC, Wang, KK, Fleischer, DE, Sharma, VK, Eisen, GM, Fennerty, MB, Hunter, JG, Bronner, MP, Goldblum, JR, Bennett, AE, Mashimo, H, Rothstein, RI, Gordon, SR, Edmundowicz, SA, Madanick, RD, Peery, AF, Muthusamy, VR, Chang, KJ, Kimmey, MB, Spechler, SJ, Siddiqui, AA, Souza, RF, Infantolino, A, Dumot, JA, Falk, GW, Galanko, JA, Jobe, BA, Hawes, RH, Hoffman, BJ, Sharma, P, Chak, A & Lightdale, CJ 2011, 'Durability of radiofrequency ablation in Barrett's esophagus with dysplasia', Gastroenterology, vol. 141, no. 2, pp. 460-468. https://doi.org/10.1053/j.gastro.2011.04.061

@article{b911807d82484cdebfa21be8dc816562,

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. ",

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",

}

TY - JOUR

T1 - Durability of radiofrequency ablation in Barrett's esophagus with dysplasia

AU - Shaheen, Nicholas J.

AU - Overholt, Bergein F.

AU - Sampliner, Richard E.

AU - Wolfsen, Herbert C.

AU - Wang, Kenneth K.

AU - Fleischer, David E.

AU - Sharma, Virender K.

AU - Eisen, Glenn M.

AU - Fennerty, M. Brian

AU - Hunter, John G.

AU - Bronner, Mary P.

AU - Goldblum, John R.

AU - Bennett, Ana E.

AU - Mashimo, Hiroshi

AU - Rothstein, Richard I.

AU - Gordon, Stuart R.

AU - Edmundowicz, Steven A.

AU - Madanick, Ryan D.

AU - Peery, Anne F.

AU - Muthusamy, V. Raman

AU - Chang, Kenneth J.

AU - Kimmey, Michael B.

AU - Spechler, Stuart J.

AU - Siddiqui, Ali A.

AU - Souza, Rhonda F.

AU - Infantolino, Anthony

AU - Dumot, John A.

AU - Falk, Gary W.

AU - Galanko, Joseph A.

AU - Jobe, Blair A.

AU - Hawes, Robert H.

AU - Hoffman, Brenda J.

AU - Sharma, Prateek

AU - Chak, Amitabh

AU - Lightdale, Charles J.

N1 - Funding Information: Funding This study was supported by funding from BÂRRX 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.

PY - 2011/8

Y1 - 2011/8

N2 - 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.

AB - 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.

KW - Cancer

KW - Endoscopic Therapy

KW - Esophagus

KW - Prevention

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Durability of radiofrequency ablation in Barrett's esophagus with dysplasia

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