Palliative radiotherapy after oesophageal cancer stent insertion: a multicentre, phase 3, randomised controlled trial (ROCS)
Session type: E-poster/poster
Median survival with advanced oesophageal cancer is 3–6 months. Self-expanding metal stent (SEMS) insertion palliates dysphagia but symptoms return within 3 months. ROCS examined whether adjuvant palliative external beam radiotherapy (pEBRT) following SEMS improved dysphagia outcomes at 12 weeks compared with usual care (UC) alone.
A multicentre, phase 3 randomised controlled trial in 23 UK centres. Adults with incurable oesophageal carcinoma were eligible if the multidisciplinary team (MDT) identified SEMS for primary management of dysphagia. Participants were randomized (1:1) to receive UC or pEBRT (20Gy/5# or 30Gy/10# to tumour/stent at risk) stratified by centre, cancer stage, histology, MDT chemotherapy-intent. The primary outcome was participant-reported dysphagia deterioration [QLQ-OG25] (>11 points), and dysphagia-related events consistent with deterioration or death by 12 weeks. Secondary outcomes included overall survival, quality of life (QoL), morbidities (including bleeding events), and cost-effectiveness. An integrated qualitative study examined trial experiences.
220 patients (n=199 modified ITT) recruited between 2013-2018. pEBRT did not reduce dysphagia deterioration: adjusted odds ratio 0·82 [95% CI 0·40–1·68], p=0·59 in those with complete data for the primary endpoint.
The pEBRT group had fewer bleeding events and longer time to first bleeding event. No time versus treatment interaction was observed for pre-specified QoL outcomes or time to first stent complication or re-intervention. Cost-utility analysis showed pEBRT was more expensive and less efficacious.
Patients with incurable oesophageal cancer having SEMS for primary management of dysphagia did not gain benefit from pEBRT. Participants in both arms reported difficulty in managing the physical and psychosocial aspects of eating restrictions. Whilst adding radiotherapy to SEMS did not improve survival, for a minority of patients at very high risk of tumour bleeding, pEBRT after SEMS might reduce bleeding risk and the need for associated interventions.
Radiotherapy in patients with incurable oesophageal cancer having SEMS for management of dysphagia, decreases quality of life without improving survival.