Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial
Single-dose brachytherapy versus metal stent placement for the palliation of dysphagia from oesophageal cancer: multicentre randomised trial
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DOI：
10.1016/s0140-6736(04)17272-3
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发表时间：
2004-10-23
期刊：
影响因子：
168.9
通讯作者：
Siersema, PD
中科院分区：
文献类型：
--
作者：
Homs, MYV;Steyerberg, EW;Siersema, PD
背景单次近距离放射治疗和自膨式金属支架置入术都是不能手术的癌症所致的食道梗阻的常用姑息性治疗方法，但各自的优缺点尚不清楚。我们进行了一项随机试验，比较近距离放射治疗和支架置入术对食道癌患者的疗效。自1999年12月至2002年6月，209例不能手术的食道癌或食管胃交界处患者被随机分为支架置入组(108例)和单次剂量(12Gy)近距离放射治疗组(101例)，治疗后进行随访。主要结果是在随访期间吞咽困难缓解，次要结果是并发症、持续性或复发性吞咽困难的治疗、与健康相关的生活质量和费用。根据治疗意向进行分析。发现9名患者(6名[近距离放射治疗]对3名[支架放置])没有接受分配的治疗。没有人因此而失去后续行动。吞咽困难在支架置入后比近距离治疗后改善得更快，但吞咽困难的长期缓解在近距离治疗后更好。支架置入术的并发症比近距离放射治疗多(108例中36例(33%)对101例中21例(21%)；p=0.02)，这主要是由于晚期出血的发生率增加(108例中14例(13%)对101例中5例(5%)；p=0.05)。两组在持续性或复发性吞咽困难(p=0.81)或中位生存期(p=0.23)方面没有差异。与支架置入术相比，生活质量评分更倾向于近距离放射治疗。支架置入(SIC)8215和近距离放射治疗(SIC)8135的总医疗费用也大致相同。尽管改善缓慢，但单剂近距离放射治疗对吞咽困难的长期缓解效果好于金属支架置入。由于近距离放射治疗的并发症也比支架置入术少，我们建议将其作为缓解食道癌吞咽困难的主要治疗方法。
Background Both single-dose brachytherapy and self-expanding metal stent placement are commonly used for palliation of oesophageal obstruction due to inoperable cancer, but their relative merits are unknown. We under-took a randomised trial to compare the outcomes of brachytherapy and stent placement in patients with oesophageal cancer.Methods Nine hospitals in the Netherlands participated in our study. Between December, 1999, and June, 2002, 209 patients with dysphagia from inoperable carcinoma of the oesophagus or oesophagogastric junction were randomly assigned to stent placement (n=108) or single-dose (12 Gy) brachytherapy (n=101), and were followed up after treatment. Primary outcome was relief of dysphagia during follow-up, and secondary outcomes were complications, treatment for persistent or recurrent dysphagia, health-related quality of life, and costs. Analysis was by intention to treat.Findings Nine patients (six [brachytherapy] vs three [stent placement]) did not receive their allocated treatments. None was lost to follow-up. Dysphagia improved more rapidly after stent placement than after brachytherapy, but long-term relief of dysphagia was better after brachytherapy. Stent placement had more complications than brachytherapy (36[33%] of 108 vs 21 [21%] of 101; p=0.02), which was mainly due to an increased incidence of late haemorrhage (14 [13%] of 108 vs five [5%] of 101; p=0.05). Groups did not differ for persistent or recurrent dysphagia (p=0.81), or for median survival (p=0.23). Quality-of-life scores were in favour of brachytherapy compared with stent placement. Total medical costs were also much the same for stent placement ((sic)8215) and brachytherapy ((sic)8135).Interpretation Despite slow improvement, single-dose brachytherapy gave better long-term relief of dysphagia than metal stent placement. Since brachytherapy was also associated with fewer complications than stent placement, we recommend it as the primary treatment for palliation of dysphagia from oesophageal cancer.