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新辅助放化疗与单纯化疗对食管癌患者吞咽困难缓解的影响:一项随机试验的次要终点分析。

Effects of neoadjuvant chemoradiotherapy vs chemotherapy alone on the relief of dysphagia in esophageal cancer patients: secondary endpoint analysis in a randomized trial.

机构信息

Division of Surgery, Department of Clinical Science Intervention and Technology, Karolinska Institutet and Department of Upper Abdominal Diseases.

Department of Gastrointestinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim.

出版信息

Dis Esophagus. 2019 Feb 1;32(2). doi: 10.1093/dote/doy069.

Abstract

Dysphagia is the most significant symptom in patients with esophageal cancer. There are different therapeutic interventions designed to relieve dysphagia, but few studies have addressed the effects of neoadjuvant therapy. The aim of this study is to compare the effects on dysphagia of neoadjuvant chemotherapy (nCT) versus neoadjuvant chemoradiotherapy (nCRT) and further to study the association between dysphagia response and histological response. Patient reported swallowing function was a secondary endpoint in the NeoRes trial, in which patients were randomized between neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy. Patients completed dysphagia questionnaires before the start and after neoadjuvant therapy, using the European Organization for Research and Treatment of Cancer (EORTC) esophageal cancer modules QLQ-OES24/OG25. Chirieac tumor regression grade (TRG) was used to assess the histological response. Out of 181 patients were randomized, of whom 87% completed the dysphagia questionnaires before and 73% after neoadjuvant treatment. Patient characteristics were similar between the treatment arms. Among patients reporting dysphagia at baseline, neoadjuvant therapy improved dysphagia in both arms. The mean dysphagia score after neoadjuvant treatment was significantly lower after nCT compared to after nCRT (P = 0.022). The reported dysphagia did not differ between those with a complete histological response (TRG 1) and those without any response at all (TRG 4) (P = 0. 583).

摘要

吞咽困难是食管癌患者最显著的症状。有不同的治疗干预措施旨在缓解吞咽困难,但很少有研究涉及新辅助治疗的效果。本研究旨在比较新辅助化疗(nCT)与新辅助放化疗(nCRT)对吞咽困难的影响,并进一步研究吞咽困难缓解与组织学反应之间的关系。NeoRes 试验将患者随机分为新辅助化疗组或新辅助放化疗组,患者报告的吞咽功能是该试验的次要终点,在该试验中,患者在新辅助治疗前后完成了欧洲癌症研究与治疗组织(EORTC)食管癌模块 QLQ-OES24/OG25 的吞咽困难问卷。Chirieac 肿瘤消退分级(TRG)用于评估组织学反应。在随机分配的 181 例患者中,有 87%的患者在新辅助治疗前完成了吞咽困难问卷,73%的患者在新辅助治疗后完成了问卷。治疗组之间的患者特征相似。在基线时有吞咽困难报告的患者中,新辅助治疗在两组中均改善了吞咽困难。与 nCRT 相比,nCT 治疗后的平均吞咽困难评分显著降低(P=0.022)。完全组织学缓解(TRG 1)和无任何反应(TRG 4)患者的报告吞咽困难无差异(P=0.583)。

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