title: Squamous overgrowth is not a safety concern for photodynamic therapy for Barrett's esophagus with high-grade dysplasia.
abstract: OBJECTIVE
  Photodynamic therapy with porfimer sodium combined with acid suppression (PHOPDT) is used to treat patients with Barrett's esophagus (BE) with high-grade dysplasia (HGD). A 5-year phase 3 trial was conducted to determine the extent of squamous overgrowth of BE with HGD after PHOPDT.
  
  
  METHODS
  Squamous overgrowth was compared in patients with BE with HGD randomly assigned (2:1) to receive PHOPDT (n=138) or 20 mg omeprazole twice daily (n=70). Patients underwent 4-quadrant jumbo esophageal biopsies every 2 cm throughout the pretreatment length of BE until 4 consecutive quarterly follow-up results were negative for HGD and then biannually up to 5 years or treatment failure. Endoscopies were reviewed by blinded gastroenterology pathologists.
  
  
  RESULTS
  Histologic assessment of 33,658 biopsies showed no significant difference (P> .05) in squamous overgrowth between groups when compared per patient (30% vs 33%) or per biopsy (0.5% vs 1.3%), or when the average number of biopsies with squamous overgrowth were compared per patient (0.48 vs 0.66). The highest grade of neoplasia per endoscopy was not found exclusively beneath squamous mucosa in any patient.
  
  
  CONCLUSIONS
  No difference was observed in squamous overgrowth between patients given PHOPDT plus omeprazole compared with only omeprazole. Squamous overgrowth did not obscure the most advanced neoplasia in any patient. Treatment of HGD with PHOPDT in patients with BE does not present a long-term risk of failure to detect subsquamous dysplasia or carcinoma.
authors.affiliation: Cleveland Clinic, Cleveland, Ohio 44195, USA. bronnem@ccf.org
authors.forename: Mary P
authors.initials: MP
authors.lastname: Bronner
authors.forename: Bergein F
authors.initials: BF
authors.lastname: Overholt
authors.forename: Shari L
authors.initials: SL
authors.lastname: Taylor
authors.forename: Rodger C
authors.initials: RC
authors.lastname: Haggitt
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: Marcia I
authors.initials: MI
authors.lastname: Canto
authors.forename: Norman
authors.initials: N
authors.lastname: Marcon
authors.forename: Marcos
authors.initials: M
authors.lastname: Pedrosa
authors.forename: Michael
authors.initials: M
authors.lastname: Grace
authors.forename: Michelle
authors.initials: M
authors.lastname: Depot
mesh_terms: D000368:Aged; D001471:Barrett Esophagus / Q000188:drug therapy* / Q000473:pathology; D001706:Biopsy; D017323:Dihematoporphyrin Ether / Q000627:therapeutic use; D004947:Esophagus / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010778:Photochemotherapy / Q000009:adverse effects*
chemical_list: D017323:Dihematoporphyrin Ether; D009853:Omeprazole