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

Gastrointest Endosc. 2007 Sep;66(3):460-8. doi: 10.1016/j.gie.2006.12.037. Epub 2007 Jul 23.


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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / pathology
  • Aged
  • Anti-Ulcer Agents / therapeutic use*
  • Barrett Esophagus / drug therapy*
  • Barrett Esophagus / mortality
  • Barrett Esophagus / pathology
  • Biopsy
  • Combined Modality Therapy
  • Dihematoporphyrin Ether
  • Disease Progression
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / mortality
  • Esophageal Neoplasms / pathology
  • Esophagus / pathology
  • Female
  • Follow-Up Studies
  • Hematoporphyrin Photoradiation*
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / therapeutic use*
  • Precancerous Conditions / drug therapy*
  • Precancerous Conditions / mortality
  • Precancerous Conditions / pathology
  • Safety
  • Single-Blind Method
  • Survival Analysis
  • Treatment Outcome


  • Anti-Ulcer Agents
  • Dihematoporphyrin Ether
  • Omeprazole