Radiotherapy after Oesophageal Cancer Stenting (ROCS): a randomised controlled trial of palliative radiotherapy in preventing post stent dysphagia deterioration in patients with advanced oesophageal cancer

Douglas Adamson, Anthony Byrne*, Catharine Porter, Jane M Blazeby, Gareth Griffiths, Annmarie Nelson, Bernadette Sewell, Mari Jones, Martina Svobodova, Deborah Fitzsimmons, Lisette Nixon, Jim Fitzgibbon, Stephen Thomas, Anthony Millen, Tom Crosby, John Staffurth, Christopher Hurt

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Abstract Background Patients with advanced oesophageal cancer have a median survival of 3-6 months, and most require intervention for dysphagia. Self expanding metal stent (SEMS) insertion is the commonest form of palliation but dysphagia deterioration, and re-intervention, is common. This study examined the effectiveness of post-stent adjuvant external beam radiotherapy (EBRT) compared to usual care (UC) alone in preventing dysphagia deterioration and reducing service use. Methods This was a multi-centre, open-label, randomised controlled trial (ISRCTN12376468; Clinicaltrials.gov: NCT01915693). Patients with incurable oesophageal carcinoma (histological confirmation excluding small cell carcinoma) receiving stent insertion as primary management of dysphagia were randomised 1:1 to UC or EBRT (20Gy in five fractions or 30Gy in ten fractions) using the method of minimisation stratified by: treating centre, stage at diagnosis (I-III vs IV), histology (squamous or other) and MDT intent to give chemotherapy (yes or no). Radiotherapy dose was 20Gy in five fractions or 30 Gy in ten fractions, pre-specified by centre. Usual care (UC) was implemented according to need as identified by the local MDT including dietetic advice, palliative and supportive care interventions, and community based health and social care follow up. Primary outcome was difference in proportions of participants with dysphagia deterioration (EORTC QLQ-OG25) by 12 weeks in a modified intention to treat population analysed when the trial closed to follow up. Cost-effectiveness was assessed at 12 weeks with exploratory cost-utility analysis at 12 months.
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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.
Original languageEnglish
JournalLancet Gastroenterology and Hepatology
Publication statusAccepted/In press - 18 Dec 2020

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