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Radiofrequency ablation reduced risk for esophageal adenocarcinoma
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Endoscopic radiofrequency ablation decreased the risk for high-grade esophageal adenocarcinoma in patients diagnosed with Barrett’s esophagus, according to results of a multicenter, randomized trial.
K. Nadine Phoa, MD, of the University of Amsterdam, and colleagues enrolled 136 patients with Barrett’s esophagus diagnosed at nine European sites from June 2007 to June 2011. Follow-up was 3 years.
Researchers randomly assigned 68 patients to endoscopic treatment with a maximum of five sessions of radiofrequency ablation. The other 68 patients were assigned endoscopic surveillance.
Neoplastic progression to high-grade dysplasia or adenocarcinoma served as the primary endpoint. Complete eradication of dysplasia and intestinal metaplasia, as well as incidence of adverse events, served as secondary outcomes.
An analysis of biopsy specimens demonstrated that ablation was associated with a considerably lower rate of neoplastic progression to high-grade dysplasia or adenocarcinoma compared with endoscopic surveillance (1.5% vs. 26.5%; 95% CI, 14.1%-35.9%), with a number needed to treat of four. Ablation also reduced the risk for progression to adenocarcinoma (1.5% for ablation vs. 8.8% for endoscopic surveillance; 95% CI, 0%-14.7%), with an number needed to treat of 13.6.
Researchers reported higher rates of complete eradication of dysplasia (92.6% vs. 27.9%) and complete eradication of intestinal metaplasia (88.2% vs. 0%) in the ablation arm (P<.001).
Ablation appeared generally safe, with 19.1% of patients experiencing treatment-related adverse event (P<.001). The most common adverse event was stricture (11.8%), which was treated with endoscopic dilation. One patient in the ablation group progressed to adenocarcinoma, which was treated with endoscopic resection, resulting in eradication of dysplasia.
The data and safety monitoring board recommended that the trial terminate early due to the superiority of ablation, as well as the potential for potential safety issues if the trial continued.
In an accompanying editorial, Klaus Mönkemüller, MD, PhD, director of the Basil I. Hirschowitz Endoscopic Center of Excellence at the University of Alabama and Birmingham, said the study is significant for determining treatment options for patients with Barrett’s esophagus and low-grade dysplasia.
“The study by Phoa et al has important implications for the treatment of low-grade dysplasia in patients with Barrett’s esophagus, supporting a proactive rather than watchful waiting approach,” Mönkemüller said. “A proactive endoscopic approach to eliminate dysplasia may result in reduced morbidity and mortality related to the progression of this disease.”
Disclosure: The researchers report funding from AstraZeneca, BEST-academia and the Fund for Scientific Research Flanders. Mönkemüller reports grant funding from Covidien.
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