title: Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia.
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).
  
  
  METHODS
  Five-year follow-up of a randomized, multicenter, multinational, pathology-blinded HGD trial.
  
  
  METHODS
  30 sites in 4 countries.
  
  
  METHODS
  208.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Thompson Cancer Survival Center, Knoxville, Tennessee 37909, USA.
authors.forename: Bergein F
authors.initials: BF
authors.lastname: Overholt
authors.forename: Kenneth K
authors.initials: KK
authors.lastname: Wang
authors.forename: J Steven
authors.initials: JS
authors.lastname: Burdick
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lightdale
authors.forename: Michael
authors.initials: M
authors.lastname: Kimmey
authors.forename: Hector R
authors.initials: HR
authors.lastname: Nava
authors.forename: Michael V
authors.initials: MV
authors.lastname: Sivak
authors.forename: Norman
authors.initials: N
authors.lastname: Nishioka
authors.forename: Hugh
authors.initials: H
authors.lastname: Barr
authors.forename: Norman
authors.initials: N
authors.lastname: Marcon
authors.forename: Marcos
authors.initials: M
authors.lastname: Pedrosa
authors.forename: Mary P
authors.initials: MP
authors.lastname: Bronner
authors.forename: Michael
authors.initials: M
authors.lastname: Grace
authors.forename: Michelle
authors.initials: M
authors.lastname: Depot
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001471:Barrett Esophagus / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D001706:Biopsy; D003131:Combined Modality Therapy; D017323:Dihematoporphyrin Ether; D018450:Disease Progression; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004947:Esophagus / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006414:Hematoporphyrin Photoradiation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011230:Precancerous Conditions / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012449:Safety; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D017323:Dihematoporphyrin Ether; D009853:Omeprazole