Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: International, partially blinded, randomized phase III trial

Bergein F. Overholt, Charles J. Lightdale, Kenneth K. Wang, Marcia Canto, Steven Burdick, Roger C. Haggitt, Mary P. Bronner, Shari L. Taylor, Michael G A Grace, Michelle Depot

Research output: Contribution to journalArticle

Abstract

Background: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma. Methods: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period. Results: There was a significant difference (p <0.0001) in favor of PORPDT (106/138 [77%]) compared with OM (27/70 [39%]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13%) (n = 18) was significantly lower (p <0.006) compared with the OM group (20%) (n = 20). The safety profile showed 94% of patients in the PORPDT group and 13% of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment. Conclusions: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.

Original languageEnglish (US)
Pages (from-to)488-498
Number of pages11
JournalGastrointestinal Endoscopy
Volume62
Issue number4
DOIs
StatePublished - Oct 2005
Externally publishedYes

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Dihematoporphyrin Ether
Barrett Esophagus
Photochemotherapy
Omeprazole
Adenocarcinoma
Therapeutics
Safety
Incidence
Population
Randomized Controlled Trials
Pathology
Physicians

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus : International, partially blinded, randomized phase III trial. / Overholt, Bergein F.; Lightdale, Charles J.; Wang, Kenneth K.; Canto, Marcia; Burdick, Steven; Haggitt, Roger C.; Bronner, Mary P.; Taylor, Shari L.; Grace, Michael G A; Depot, Michelle.

In: Gastrointestinal Endoscopy, Vol. 62, No. 4, 10.2005, p. 488-498.

Research output: Contribution to journalArticle

Overholt, Bergein F. ; Lightdale, Charles J. ; Wang, Kenneth K. ; Canto, Marcia ; Burdick, Steven ; Haggitt, Roger C. ; Bronner, Mary P. ; Taylor, Shari L. ; Grace, Michael G A ; Depot, Michelle. / Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus : International, partially blinded, randomized phase III trial. In: Gastrointestinal Endoscopy. 2005 ; Vol. 62, No. 4. pp. 488-498.
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abstract = "Background: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma. Methods: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period. Results: There was a significant difference (p <0.0001) in favor of PORPDT (106/138 [77{\%}]) compared with OM (27/70 [39{\%}]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13{\%}) (n = 18) was significantly lower (p <0.006) compared with the OM group (20{\%}) (n = 20). The safety profile showed 94{\%} of patients in the PORPDT group and 13{\%} of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment. Conclusions: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.",
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T1 - Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus

T2 - International, partially blinded, randomized phase III trial

AU - Overholt, Bergein F.

AU - Lightdale, Charles J.

AU - Wang, Kenneth K.

AU - Canto, Marcia

AU - Burdick, Steven

AU - Haggitt, Roger C.

AU - Bronner, Mary P.

AU - Taylor, Shari L.

AU - Grace, Michael G A

AU - Depot, Michelle

PY - 2005/10

Y1 - 2005/10

N2 - Background: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma. Methods: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period. Results: There was a significant difference (p <0.0001) in favor of PORPDT (106/138 [77%]) compared with OM (27/70 [39%]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13%) (n = 18) was significantly lower (p <0.006) compared with the OM group (20%) (n = 20). The safety profile showed 94% of patients in the PORPDT group and 13% of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment. Conclusions: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.

AB - Background: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma. Methods: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period. Results: There was a significant difference (p <0.0001) in favor of PORPDT (106/138 [77%]) compared with OM (27/70 [39%]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13%) (n = 18) was significantly lower (p <0.006) compared with the OM group (20%) (n = 20). The safety profile showed 94% of patients in the PORPDT group and 13% of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment. Conclusions: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.

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