Barrett's esophagus may lead to high-grade dysplasia and adenocarcinoma.
Dr Bergein Overholt and colleagues examined the impact of treating patients with Barrett's esophagus and with high grade dysplasia.
The researchers used porfimer sodium and photodynamic therapy for ablating high grade dysplasia and reducing the incidence of esophageal adenocarcinoma.
The research team designed a multicenter, partially blinded, randomized clinical trial conducted in these patients from 30 contributing centers.
The researchers reported that patients and the physicians were not blinded to the treatment.
A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population.
|Cancer occurred in 13% with the combination treatment vs 20% with omeprazole only|
The researchers randomized patients on a 2 to 1 basis to compare photodynamic therapy with porfimer sodium plus omeprazole, and omeprazole only.
The main outcome measurement was complete high grade dysplasia ablation occurring at any time during the study period.
The team found a difference in favor of photodynamic therapy with porfimer sodium plus omeprazole vs omeprazole only in complete ablation of high grade dysplasia.
This finding was consistent at any time during the study period.
The occurrence of adenocarcinoma in the photodynamic therapy with porfimer sodium plus omeprazole group was 13%, lower than the omeprazole group at 20%.
The safety profile showed 94% of patients in the photodynamic therapy with porfimer sodium plus omeprazole group had treatment-related adverse effects.
The research team noted that 13% of patients in the omeprazole only group had treatment-related adverse effects.
The limitations of the study were that photodynamic therapy may have had to be applied more than once and that patients spent more time in treatment.
Dr Overholt's team reported, “Photodynamic therapy with porfimer sodium in conjunction with omeprazole is an effective therapy for ablating high grade dysplasia in patients with Barrett's esophagus and in reducing the incidence of esophageal adenocarcinoma.”