Irradiated Stents Prolong Survival and Reduce Dysphagia Compared With Conventional Stents as Palliative Treatment in Unresectable Esophageal Cancer
In a single-blind phase III trial reported in The Lancet Oncology, Zhu et al compared the use of 125iodine seed–loaded vs conventional covered stents along with single high-dose brachytherapy as palliative treatment in patients with unresectable esophageal cancer. Use of the irradiated stents was associated with a small but statistically significant improvement in overall survival and reduced dysphagia during follow-up.
Study Details
In the study, 160 patients aged ≥ 20 years with progressive dysphagia and unresectable tumors due to extensive lesions, metastases, or poor medical condition from 16 hospitals in China were randomly assigned between November 2009 and October 2012 to receive an irradiation stent (n = 80) or conventional stent (n = 80). Totals of 73 and 75 patients were evaluable in a modified intent-to-treat analysis. Stent placement was successful in all of these patients.
Baseline characteristics were genrally balanced in the two groups except for a greater proportion of male patients (84% vs 71%) in the irradiation stent group and differences in tumor location (superior segment in 10% vs 20%, middle segment in 66% vs 45%, inferior segment in 35% vs 25%).
Increased Overall Survival
Median follow-up was 138 days in the irradiation group and 123 days in the control group. Median overall survival was 177 vs 147 days (P = .0046). On multivariate analysis including tumor location, sex, stent type, and previous chemoradiation, stent type was the sole independent predictor of death (hazard ratio [HR] = 0.595, P = .0060).
Effect on Dysphagia
Dysphagia was scored as 0 for none, 1 for a normal diet that avoided certain foods (such as raw apple and steak), 2 for semisolid diet, 3 for fluids only, and 4 for complete dysphagia. Dysphagia was relieved 1 day after stent insertion in both groups, with mean dysphagia scores decreasing from 3.3 to 1.4 in the irradiation group and from 3.4 to 1.3 in the control group. Mean dysphagia sores were significantly lower in the irradiation group at 1 month after the procedure and remained so for the duration of follow-up (up to approximately 480 days in the irradiation group and 390 days in the control group).
Adverse Events
Major complications and adverse events in the irradiation vs control group were recurrent dysphagia (28% vs 27%), severe chest pain (23% vs 20%), aspiration pneumonia (15% vs 19%), fistula formation (8% vs 7%), and hemorrhage (7% vs 7%).
The investigators concluded, “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.”
Gao-Jun Teng, MD, of Southeast University, Nanjing, is the corresponding author for the Lancet Oncology article.
The study was funded by the National High-Tech Research Foundation of China, National Basic Research Program of China, Jiangsu Provincial Special Program of Medical Science, National Scientific and Technical Achievement Translation Foundation, and National Natural Science Foundation of China. The study authors reported no potential conflicts of interest.
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