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

Bergein F. Overholt, Kenneth K. 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

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284 Scopus citations

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 1 2007

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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    Overholt, B. F., Wang, K. K., Burdick, J. S., Lightdale, C. J., Kimmey, M., Nava, H. R., Sivak, M. V., Nishioka, N., Barr, H., Marcon, N., Pedrosa, M., Bronner, M. P., Grace, M., & Depot, M. (2007). Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. Gastrointestinal endoscopy, 66(3), 460-468. https://doi.org/10.1016/j.gie.2006.12.037