Adding external beam to intra-luminal brachytherapy improves palliation in obstructive squamous cell oesophageal cancer: A prospective multi-centre randomized trial of the International Atomic Energy Agency

Background: Whether the combination of high dose-rate brachytherapy (HDRBT) and External Beam Radiation Therapy (EBRT) is superior to HDRBT alone for the palliation of oesophageal cancer has only been explored in a previous IAEA pilot randomized trial. Methods: Two hundred and nineteen patients were randomized to adding EBRT or not, after receiving two fractions of HDRBT within 1 week. Each HDRBT consisted of 8 Gy prescribed at 1 cm from source centre. Patients randomized to EBRT received 30 Gy in 10 fractions. The primary outcome was dysphagia-relief experience (DRE). Additional outcomes included various scores, performance status, weight and adverse events. A majority of charts, imaging and radiotherapy plans were externally audited. Results: Median follow-up was 197 days, with a median OS of 188 days and an 18% survival rate at 1 year. DRE was significantly improved with combined therapy, for an absolute benefit of +18% at 200 days from randomization (p = 0.019). In longitudinal regression analyses, scores for dysphagia (p = 0.00005), odynophagia (p = 0.006), regurgitation (p = 0.00005), chest pain (p = 0.0038) and performance status (p = 0.0015) were all significantly improved. In contrast, weight, toxicities and overall survival were not different between study arms. Conclusion: Symptom improvement occurs with the addition of EBRT to standard HDRBT. The combination is well tolerated and relatively safe.