Findings 220 patients were randomised between December 2013 and August 2018 from 23 UK centres. There was no clinically or statistically significant evidence that radiotherapy reduced dysphagia deterioration: 36/74 (48·6%) with UC vs 34/75 (45·3%) with EBRT (adjusted OR 0·82; 95%CI 0·40-1·68; p=0·59) in those with complete data. There was no clinically or statistically significant difference in overall survival (weeks): median 19·7 (95%CI 14·4-27·7) with UC and 18·9 (95%CI 14·7-25·6) with EBRT (adjusted HR 1·06; 95%CI 0·78-1·45; p=0·70; n=199). Median time to first bleeding event (weeks) was longer with EBRT: 49·0 (95%CI 33·3-not reached) vs 65·9 (95%CI 52·7-not reached) (adjusted sub-hazard ratio 0·52; 95%CI 0·28-0·97; p=0·038; n=199). No time-treatment interaction was found for WHO performance status or the pre-specified quality of life scales of secondary interest. There was no evidence of differences in stent complications. The most common (grade 3-4) adverse events was fatigue: 19/102 (18.6%) with UC and 22/97 (22.7%) with EBRT. EBRT was dominated by UC (i.e. more expensive and less effective). Interpretation Patients with advanced oesophageal cancer having SEMS insertion as primary management of their dysphagia will not gain additional benefit from concurrent palliative radiotherapy and it should not be routinely offered. For a minority clinically considered to be at high risk of tumour bleeding, concurrent palliative radiotherapy may reduce bleeding risk and associated interventions.
|Journal||Lancet Gastroenterology and Hepatology|
|Publication status||Accepted/In press - 18 Dec 2020|