Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia

Bergein F. Overholt, Kenneth Ke Ning Wang, J. Steven Burdick, Charles J. Lightdale, Michael Kimmey, Hector R. Nava, Michael V. Sivak, Norman Nishioka, Hugh Barr, Norman Marcon, Marcos Pedrosa, Mary P. Bronner, Michael Grace, Michelle Depot

Research output: Contribution to journalArticle

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Abstract

Background: Barrett's esophagus (BE) with high-grade dysplasia (HGD) is a risk factor for development of esophageal carcinoma. Photodynamic therapy (PDT) with Photofrin (PHO) has been used to eliminate HGD in BE. Objective: Our purpose was to compare PHOPDT plus omeprazole with omeprazole only (OM). Design: Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial. Setting: 30 sites in 4 countries. Patients: 208. Interventions: Patients with BE and HGD were randomized (2:1) to PHOPDT (n = 138) or OM (n = 70) into a 2-year trial followed up for 3 more years. PHOPDT patients received 2 mg/kg PHO intravenously followed by endoscopic laser light exposure of Barrett's mucosa at a wavelength of 630 nm within 40 to 50 hours to a maximum of 3 courses at least 90 days apart. Both groups received 20 mg of OM twice daily. Pathologists at one center assessed biopsy specimens in a blinded fashion. Main Outcome Measurement: HGD ablation status over 5 years of follow-up. Results: At 5 years PHOPDT was significantly more effective than OM in eliminating HGD (77% [106/138] vs 39% [27/70], P < .0001). A secondary outcome measure preventing progression to cancer showed a significant difference (P = .027) with about half the likelihood of cancer occurring in PHOPDT (21/138 [15%]) compared with OM (20/70 [29%]), with a significantly (P = .004) longer time to progression to cancer favoring PHOPDT. Limitations: Not all patients were available for follow-up. Conclusions: This 5-year randomized trial of BE patients with HGD demonstrates that PHOPDT is a clinically and statistically effective therapy in producing long-term ablation of HGD and reducing the potential impact of cancer compared with OM.

Original languageEnglish (US)
Pages (from-to)460-468
Number of pages9
JournalGastrointestinal Endoscopy
Volume66
Issue number3
DOIs
StatePublished - Sep 2007
Externally publishedYes

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Dihematoporphyrin Ether
Photochemotherapy
Barrett Esophagus
Safety
Omeprazole
Neoplasms
Mucous Membrane
Lasers
Outcome Assessment (Health Care)
Pathology
Carcinoma
Biopsy
Light

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. / Overholt, Bergein F.; Wang, Kenneth Ke Ning; Burdick, J. Steven; Lightdale, Charles J.; Kimmey, Michael; Nava, Hector R.; Sivak, Michael V.; Nishioka, Norman; Barr, Hugh; Marcon, Norman; Pedrosa, Marcos; Bronner, Mary P.; Grace, Michael; Depot, Michelle.

In: Gastrointestinal Endoscopy, Vol. 66, No. 3, 09.2007, p. 460-468.

Research output: Contribution to journalArticle

Overholt, BF, Wang, KKN, Burdick, JS, Lightdale, CJ, Kimmey, M, Nava, HR, Sivak, MV, Nishioka, N, Barr, H, Marcon, N, Pedrosa, M, Bronner, MP, Grace, M & Depot, M 2007, 'Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia', Gastrointestinal Endoscopy, vol. 66, no. 3, pp. 460-468. https://doi.org/10.1016/j.gie.2006.12.037
Overholt, Bergein F. ; Wang, Kenneth Ke Ning ; Burdick, J. Steven ; Lightdale, Charles J. ; Kimmey, Michael ; Nava, Hector R. ; Sivak, Michael V. ; Nishioka, Norman ; Barr, Hugh ; Marcon, Norman ; Pedrosa, Marcos ; Bronner, Mary P. ; Grace, Michael ; Depot, Michelle. / Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. In: Gastrointestinal Endoscopy. 2007 ; Vol. 66, No. 3. pp. 460-468.
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abstract = "Background: Barrett's esophagus (BE) with high-grade dysplasia (HGD) is a risk factor for development of esophageal carcinoma. Photodynamic therapy (PDT) with Photofrin (PHO) has been used to eliminate HGD in BE. Objective: Our purpose was to compare PHOPDT plus omeprazole with omeprazole only (OM). Design: Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial. Setting: 30 sites in 4 countries. Patients: 208. Interventions: Patients with BE and HGD were randomized (2:1) to PHOPDT (n = 138) or OM (n = 70) into a 2-year trial followed up for 3 more years. PHOPDT patients received 2 mg/kg PHO intravenously followed by endoscopic laser light exposure of Barrett's mucosa at a wavelength of 630 nm within 40 to 50 hours to a maximum of 3 courses at least 90 days apart. Both groups received 20 mg of OM twice daily. Pathologists at one center assessed biopsy specimens in a blinded fashion. Main Outcome Measurement: HGD ablation status over 5 years of follow-up. Results: At 5 years PHOPDT was significantly more effective than OM in eliminating HGD (77{\%} [106/138] vs 39{\%} [27/70], P < .0001). A secondary outcome measure preventing progression to cancer showed a significant difference (P = .027) with about half the likelihood of cancer occurring in PHOPDT (21/138 [15{\%}]) compared with OM (20/70 [29{\%}]), with a significantly (P = .004) longer time to progression to cancer favoring PHOPDT. Limitations: Not all patients were available for follow-up. Conclusions: This 5-year randomized trial of BE patients with HGD demonstrates that PHOPDT is a clinically and statistically effective therapy in producing long-term ablation of HGD and reducing the potential impact of cancer compared with OM.",
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T1 - Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia

AU - Overholt, Bergein F.

AU - Wang, Kenneth Ke Ning

AU - Burdick, J. Steven

AU - Lightdale, Charles J.

AU - Kimmey, Michael

AU - Nava, Hector R.

AU - Sivak, Michael V.

AU - Nishioka, Norman

AU - Barr, Hugh

AU - Marcon, Norman

AU - Pedrosa, Marcos

AU - Bronner, Mary P.

AU - Grace, Michael

AU - Depot, Michelle

PY - 2007/9

Y1 - 2007/9

N2 - Background: Barrett's esophagus (BE) with high-grade dysplasia (HGD) is a risk factor for development of esophageal carcinoma. Photodynamic therapy (PDT) with Photofrin (PHO) has been used to eliminate HGD in BE. Objective: Our purpose was to compare PHOPDT plus omeprazole with omeprazole only (OM). Design: Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial. Setting: 30 sites in 4 countries. Patients: 208. Interventions: Patients with BE and HGD were randomized (2:1) to PHOPDT (n = 138) or OM (n = 70) into a 2-year trial followed up for 3 more years. PHOPDT patients received 2 mg/kg PHO intravenously followed by endoscopic laser light exposure of Barrett's mucosa at a wavelength of 630 nm within 40 to 50 hours to a maximum of 3 courses at least 90 days apart. Both groups received 20 mg of OM twice daily. Pathologists at one center assessed biopsy specimens in a blinded fashion. Main Outcome Measurement: HGD ablation status over 5 years of follow-up. Results: At 5 years PHOPDT was significantly more effective than OM in eliminating HGD (77% [106/138] vs 39% [27/70], P < .0001). A secondary outcome measure preventing progression to cancer showed a significant difference (P = .027) with about half the likelihood of cancer occurring in PHOPDT (21/138 [15%]) compared with OM (20/70 [29%]), with a significantly (P = .004) longer time to progression to cancer favoring PHOPDT. Limitations: Not all patients were available for follow-up. Conclusions: This 5-year randomized trial of BE patients with HGD demonstrates that PHOPDT is a clinically and statistically effective therapy in producing long-term ablation of HGD and reducing the potential impact of cancer compared with OM.

AB - Background: Barrett's esophagus (BE) with high-grade dysplasia (HGD) is a risk factor for development of esophageal carcinoma. Photodynamic therapy (PDT) with Photofrin (PHO) has been used to eliminate HGD in BE. Objective: Our purpose was to compare PHOPDT plus omeprazole with omeprazole only (OM). Design: Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial. Setting: 30 sites in 4 countries. Patients: 208. Interventions: Patients with BE and HGD were randomized (2:1) to PHOPDT (n = 138) or OM (n = 70) into a 2-year trial followed up for 3 more years. PHOPDT patients received 2 mg/kg PHO intravenously followed by endoscopic laser light exposure of Barrett's mucosa at a wavelength of 630 nm within 40 to 50 hours to a maximum of 3 courses at least 90 days apart. Both groups received 20 mg of OM twice daily. Pathologists at one center assessed biopsy specimens in a blinded fashion. Main Outcome Measurement: HGD ablation status over 5 years of follow-up. Results: At 5 years PHOPDT was significantly more effective than OM in eliminating HGD (77% [106/138] vs 39% [27/70], P < .0001). A secondary outcome measure preventing progression to cancer showed a significant difference (P = .027) with about half the likelihood of cancer occurring in PHOPDT (21/138 [15%]) compared with OM (20/70 [29%]), with a significantly (P = .004) longer time to progression to cancer favoring PHOPDT. Limitations: Not all patients were available for follow-up. Conclusions: This 5-year randomized trial of BE patients with HGD demonstrates that PHOPDT is a clinically and statistically effective therapy in producing long-term ablation of HGD and reducing the potential impact of cancer compared with OM.

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