Palliative Stenting With or Without Radiotherapy for Inoperable Esophageal Carcinoma: A Randomized Trial

Abstract

A majority of patients with esophageal cancer present with inoperable disease and require rapid and long-lasting palliation of dysphagia. To compare the duration of relief of dysphagia in patients with inoperable esophageal cancer treated with esophageal stenting alone or a combination of esophageal stenting and external beam radiotherapy (EBRT), and to assess overall survival, treatment-related complications, and quality of life (QOL) in the two groups. Patients with inoperable esophageal cancer and with high grade dysphagia were randomized to receive esophageal stenting with self-expandable metal stent (Ultraflex) alone (Group I), versus a combination of stenting followed by EBRT (30 gray in ten divided fractions over 2 weeks) (Group II). Dysphagia relief, overall survival, QOL (using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, version 3), and treatment-related complications were assessed in the two groups. From April 2007 to March 2009, 84 patients were randomized to receive esophageal stent alone (42 patients) or a combination of stent and EBRT (42 patients). The two groups were comparable in demographics, tumor characteristics, indications for palliative treatment, and pretreatment dysphagia score. Dysphagia scores improved significantly in both groups following stent insertion. However, dysphagia relief was more sustained in Group II than in Group I (7 vs. 3 months, p = 0.002). Overall median survival was significantly higher in Group II than in Group I (180 vs. 120 days, p = 0.009). Addition of radiotherapy following stenting prolonged the mean dysphagia-free survival (118.6 ± 55.8 vs. 96.8 ± 43.0 days, p = 0.054). There was significant improvement in all QOL parameters at 1 week after stenting. The QOL, however, significantly declined immediately after radiotherapy. There was no treatment-related mortality, and the incidence of complications was similar in the two groups. Post-stenting EBRT effectively prolongs duration of dysphagia relief and improves overall survival in inoperable esophageal cancer.