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Conventional stents versus stents loaded with 125iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial - 06/05/14

Doi : 10.1016/S1470-2045(14)70131-7 
Hai-Dong Zhu, MD a, †, Jin-He Guo, MD a, †, Ai-Wu Mao b, †, Wei-Fu Lv, MD c, †, Jian-Song Ji, MD d, †, Wen-Hui Wang, MD e, Bin Lv, MD f, Rui-Min Yang, MD g, Wei Wu, MD h, Cai-Fang Ni, MD i, Jie Min, MD j, Guang-Yu Zhu, MD a, Li Chen, MD a, Mei-Ling Zhu, MD k, Zhen-Yu Dai, MD l, Peng-Fei Liu, MD m, Jian-Ping Gu, MD n, Wei-Xin Ren, MD o, Rui-Hua Shi, MD p, Gao-Feng Xu, MD q, Shi-Cheng He, MD a, Gang Deng, MD a, Gao-Jun Teng, ProfMD a, ⁎
a Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, Nanjing, China 
b Department of Interventional Radiology, Shanghai St Luke’s Hospital, Shanghai, China 
c Department of Interventional Radiology, Imaging Center, Anhui Provincial Hospital, Hefei, China 
d Department of Radiology, Lishui Central Hospital, Wenzhou Medical College, Lishui, China 
e Department of Interventional Radiology, The First Hospital, Lanzhou University, Lanzhou, China 
f Department of Gastroenterology, The Affiliated Hospital of Zhejiang Traditional Chinese Medicine College, Hangzhou, China 
g Department of Interventional Radiology, First Affiliated Hospital of Xinxiang Medical College, Weihui, China 
h Department of Gastroenterology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China 
i Department of Interventional Radiology, First Affiliated Hospital of Soochow University, Suzhou, China 
j Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, China 
k Department of Gastroenterology, Suqian People’s Hospital, Drum Tower Hospital Group, Nanjing, Suqian, China 
l Department of Radiology, The Affiliated Yancheng hospital of Southeast University Medical College, Yancheng, China 
m Department of Gastroenterology, The Affiliated Jiangyin People’s Hospital of Southeast University Medical College, Jiangyin, China 
n Department of Interventional Radiology, Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, China 
o Department of Interventional Radiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China 
p Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 
q Department of Radiology, The First People’s Hospital of Yancheng, Yancheng 224001, China 

* Correspondence to: Prof Gao-Jun Teng, Department of Radiology, Zhong-da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China

Summary

Background

The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer.

Methods

In this multicentre, single-blind, randomised, phase 3 trial, we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China. We included adult patients (aged ≥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. This study is registered with ClinicalTrials.gov, number NCT01054274.

Findings

Between Nov 1, 2009, and Oct 31, 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 (IQR 72–207), 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 (95% CI 153–201) in the irradiation group versus 147 days (124–170) 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 (six [8%] vs five [7%]), aspiration pneumonia (11 [15%] vs 14 [19%]), haemorrhage (five [7%] vs five [7%]), and recurrent dysphagia (21 [28%] vs 20 [27%]).

Interpretation

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.

Funding

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.

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Vol 15 - N° 6

P. 612-619 - mai 2014 Retour au numéro
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