Department of Oncology, Oslo University Hospital, Norway.
Radiother Oncol. 2013 Jun;107(3):428-33. doi: 10.1016/j.radonc.2013.04.008. Epub 2013 May 3.
To investigate whether a combination of self-expanding metal stent (SEMS) and brachytherapy provided more rapid and prolonged effect on dysphagia without increased pain compared to brachytherapy alone in patients with incurable oesophageal cancer.
41 Patients were randomised to SEMS followed by brachytherapy, 8 Gy×3 (n=21) or brachytherapy alone, 8 Gy×3 (n=20). Change in dysphagia and pain three and seven weeks after randomisation (FU1 and FU2) was assessed by patient-reported outcome. Dysphagia, other symptoms and health-related quality of life were assessed every four weeks thereafter. The study was closed before the estimated patient-number was reached due to slow recruitment.
Patients receiving SEMS followed by brachytherapy had significantly improved dysphagia at FU1 compared to patients receiving brachytherapy alone (n=35). Difference in pain was not observed. At FU2, patients in both arms (n=21) had less dysphagia. Four patients in the combined treatment arm experienced manageable complications, no complications occurred after brachytherapy alone.
For the relief of dysphagia, SEMS followed by brachytherapy is preferable and safe for patients in need of immediate alleviation, while brachytherapy with or without preceding SEMS provides relief within a few weeks after treatment.
研究在无法治愈的食管癌患者中，与单纯近距离放疗相比，自膨式金属支架（SEMS）联合近距离放疗是否能更快、更持久地缓解吞咽困难，且不会增加疼痛。
41 名患者被随机分为 SEMS 后行近距离放疗组（n=21）和单纯近距离放疗组（n=20）。在随机分组后 3 周（FU1）和 7 周（FU2），通过患者报告的结局评估吞咽困难和疼痛的变化。此后每 4 周评估一次吞咽困难、其他症状和健康相关的生活质量。由于招募缓慢，研究在预计的患者人数达到之前提前关闭。
与单纯近距离放疗组相比，接受 SEMS 后行近距离放疗的患者在 FU1 时吞咽困难明显改善（n=35）。疼痛差异无统计学意义。在 FU2 时，两组患者（n=21）的吞咽困难均有所减轻。联合治疗组有 4 例患者出现可管理的并发症，单纯近距离放疗后无并发症发生。
对于需要立即缓解的患者，SEMS 联合近距离放疗在缓解吞咽困难方面是优选且安全的，而单纯近距离放疗或在近距离放疗前放置 SEMS 均可在治疗后数周内缓解吞咽困难。
