Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia.
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.
Overholt
Bergein F
BF
Thompson Cancer Survival Center, Knoxville, Tennessee 37909, USA.
Wang
Kenneth K
KK
Burdick
J Steven
JS
Lightdale
Charles J
CJ
Kimmey
Michael
M
Nava
Hector R
HR
Sivak
Michael V
MV
Nishioka
Norman
N
Barr
Hugh
H
Marcon
Norman
N
Pedrosa
Marcos
M
Bronner
Mary P
MP
Grace
Michael
M
Depot
Michelle
M
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
D000897:Anti-Ulcer Agents; D017323:Dihematoporphyrin Ether; D009853:Omeprazole