Rees J, Hurt C N, Gollins S, Mukherjee S, Maughan T, Falk S J, Staffurth J, Ray R, Bashir N, Geh J I, Cunningham D, Roy R, Bridgewater J, Griffiths G, Nixon L S, Blazeby J M, Crosby T
1] Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK [2] Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Wales Cancer Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.
Br J Cancer. 2015 Aug 11;113(4):603-10. doi: 10.1038/bjc.2015.258. Epub 2015 Jul 23.
Limited data describe patient-reported outcomes (PROs) of localised oesophageal cancer treated with definitive chemoradiotherapy(CRT). The phase 2/3 SCOPE-1 trial assessed the effectiveness of CRT±cetuximab. The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here.
Patients undergoing CRT±cetuximab within the SCOPE-1 trial (258 patients from 36 UK centres) completed generic-, disease- and treatment-specific health-related quality of life (HRQL) questionnaires (EORTC QLQ-C30, QLQ-OES18, Dermatology Life-Quality Index (DLQI)) at baseline and at 7, 13, 24, 52 and 104 weeks. Mean EORTC functional scale scores (>15 point change significant), DLQI scores (>4 point change significant) and proportions of patients (>15% significant) with 'minimal' or 'severe' symptoms are presented.
Questionnaire response rates were good. At baseline, EORTC functional scores were high (>75%) and few symptoms were reported except for severe problems with fatigue, insomnia and eating-related symptoms (e.g., appetite loss, dysphagia, dry mouth) in both groups(>15%). Functional aspects of health deteriorated and symptoms increased with treatment and by week 13 global quality of life, physical, role and social function significantly deteriorated and more problems with fatigue, dyspnoea, appetite loss and trouble with taste were reported. Recovery occurred by 6 months (except severe fatigue and insomnia in >15% of patients) and maintained at follow-up with no differences between groups.
CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL; however, recovery is achieved by 6 months and maintained with the exception of persisting problems with severe fatigue and insomnia. The data suggest that the HRQL recovery after definitive CRT is quicker, and there is little lasting deficit compared with treatment including surgery. These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer.
关于接受根治性放化疗(CRT)的局限性食管癌患者报告结局(PROs)的数据有限。2/3期SCOPE-1试验评估了CRT±西妥昔单抗的有效性。该试验首次提供了一个机会来描述一组接受CRT治疗的多中心患者的PROs,内容如下。
在SCOPE-1试验中接受CRT±西妥昔单抗治疗的患者(来自英国36个中心的258例患者)在基线以及第7、13、24、52和104周完成了通用、疾病和治疗特异性的健康相关生活质量(HRQL)问卷(欧洲癌症研究与治疗组织QLQ-C30、QLQ-OES18、皮肤病生活质量指数(DLQI))。呈现了欧洲癌症研究与治疗组织功能量表的平均得分(变化>15分有显著意义)、DLQI得分(变化>4分有显著意义)以及有“轻微”或“严重”症状的患者比例(>15%有显著意义)。
问卷回复率良好。在基线时,欧洲癌症研究与治疗组织的功能得分较高(>75%),除两组中严重的疲劳、失眠和饮食相关症状(如食欲减退、吞咽困难、口干)(>15%)外,报告的症状较少。随着治疗的进行,健康的功能方面恶化,症状增加,到第13周时,总体生活质量、身体、角色和社会功能显著恶化,报告了更多的疲劳、呼吸困难、食欲减退和味觉问题。6个月时恢复(>15%的患者严重疲劳和失眠除外),随访时维持,两组之间无差异。
局限性食管癌的CRT对HRQL的许多方面有显著的不利影响;然而,6个月时可实现恢复,除了持续存在的严重疲劳和失眠问题外可维持。数据表明,根治性CRT后的HRQL恢复更快,与包括手术在内的治疗相比,几乎没有持久的缺陷。这些数据需要与评估包括食管癌手术在内的治疗的研究中的HRQL数据进行比较。