Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A case series of 29 patients (18 with moderate‑grade squamous intra‑epithelial neoplasia, 10 with high‑grade squamous intra‑epithelial neoplasia and 1 with early squamous cell carcinoma) treated by radiofrequency ablation reported complete response (defined as absence of disease from any biopsy in the treatment area) in 86% (25/29) of patients at 3 months and 97% (28/29) of patients at 12‑month follow‑up.
4.2 A case series of 20 patients (12 with squamous high‑grade dysplasia and 8 with early squamous cell carcinoma confined to the mucosa) treated by radiofrequency ablation reported that in 50% (10/20) of patients, there was complete reversal of dysplasia at 12 months after a median of 1 treatment. Of these patients, 80% (8/10) remained free of dysplasia at a median follow‑up of 24 months.
4.3 The case series of 20 patients reported that 20% (2/10) of patients had a recurrence after initial successful radiofrequency ablation. In 1 patient this progressed to invasive cancer. The other patient had multifocal low‑grade dysplasia and after 4 further radiofrequency ablation procedures still had low‑grade dysplasia at 41‑month follow‑up.
4.4 The case series of 29 patients reported that there was no neoplastic progression (defined as detection of early oesophageal cell neoplasia of a more severe histological grade) at 12‑month follow‑up.
4.5 The case series of 20 patients reported that in 30% (6/20) of patients, dysplasia progressed to invasive squamous cell cancer (defined as infiltration into the submucosal layer or beyond) at 1‑year follow‑up.
4.6 The specialist advisers listed key efficacy outcomes as eradication of squamous dysplasia and reduction in development of squamous carcinoma of the oesophagus.