Patients with progressive dysphagia and unresectable esophageal cancer who received stents loaded with 125iodine radioactive seeds demonstrated improved OS compared with patients who received conventional metallic stents, according to phase 3 study results.
The analysis included 160 patients aged at least 20 years from 16 hospitals in China. Patients had unresectable tumors due to extensive lesions, metastases or poor medical condition, and each patient had an ECOG performance status score of 0 to 3.
Researchers randomly assigned patients the 125iodine seed irradiation stent (n=80) or the conventional covered self-expandable metallic stent (n=80) with single high-dose brachytherapy between 2009 and 2012.
Median follow-up was 138 days (interquartile range, 72-207).
Researchers successfully placed stents in 148 patients, which included 73 patients in the irradiation arm and 75 patients in the conventional arm.
Median OS among patients in the irradiation arm was 177 days (95% CI, 153-201), which was significantly longer than the 147-day (95% CI, 124-170) median OS observed in the conventional-stent arm.
More patients in the irradiation arm experienced recurrent dysphagia (28% vs. 27%), severe chest pain (23% vs. 20%) and fistula formation (8% vs. 7%). More patients in the control arm experienced aspiration pneumonia (19% vs. 15%). Hemorrhage was observed among 7% of patients in both arms.
“The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable esophageal cancer,” the researchers wrote. “The insertion of an esophageal stent loaded with 125iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent.”
Disclosure: The study was funded by the Jiangsu Provincial Special Program of Medical Science, National Basic Research Program of China, National High-tech Research Foundation of China, National Natural Science Foundation of China and the National Scientific and Technical Achievement Translation Foundation.