The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer.
A study has assessed the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer.
In this multicentre, single-blind, randomised, phase 3 trial, patients with unresectable oesophageal cancer from 16 hospitals in China were enrolled. Researchers have included adult patients ( aged greater than or equal to 20 years ) with progressive dysphagia, unresectable tumours due to extensive lesions, metastases, or poor medical condition, and with clear consciousness, cooperation, and an Eastern Cooperative Oncology Group ( ECOG ) performance status score of 0-3.
Eligible patients were randomly assigned ( in 1:1 ratio, no stratification ) to receive either a stent loaded with 125Iodine radioactive seeds ( irradiation group ) or a conventional oesophageal stent ( control group ).
The primary endpoint was overall survival.
Survival analyses were done in a modified intention-to-treat group.
During the period 2009-2012, 160 patients were randomly assigned to receive treatment with either an irradiation stent ( n=80 ) or a conventional stent ( n=80 ).
During a median follow-up of 138 days, 148 stents ( 73 in the irradiation group and 75 in the control group ) were successfully placed into the diseased oesophagus in 148 participants.
Median overall survival was 177 days in the irradiation group versus 147 days in the control group ( p=0.0046 ).
Major complications and side-effects of the treatment were severe chest pain ( 17 [ 23% ] of 73 patients in the irradiation group vs 15 [ 20% ] of 75 patents in the control group ), fistula formation ( 6 [ 8% ] vs 5 [ 7% ] ), aspiration pneumonia ( 11 [ 15% ] vs 14 [ 19% ] ), haemorrhage ( 5 [ 7% ] vs 5 [ 7% ] ), and recurrent dysphagia ( 21 [ 28% ] vs 20 [ 27% ] ).
In conclusion, in patients with unresectable oesophageal cancer, the insertion of an oesophageal stent loaded with 125Iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent. ( Xagena )
Zhu HD et al, The Lancet Oncology 2014; 15: 612-619