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Impact of neoadjuvant chemoradiotherapy on health-related quality of life in long-term survivors of esophageal or junctional cancer: results from the randomized CROSS trial.
Annals of Oncology ( IF 50.5 ) Pub Date : 2018-02-01 , DOI: 10.1093/annonc/mdx726
B J Noordman 1 , M G E Verdam 2 , S M Lagarde 1 , J Shapiro 1 , M C C M Hulshof 3 , M I van Berge Henegouwen 4 , B P L Wijnhoven 1 , G A P Nieuwenhuijzen 5 , J J Bonenkamp 6 , M A Cuesta 7 , J Th M Plukker 8 , E J Spillenaar Bilgen 9 , E W Steyerberg 10 , A van der Gaast 11 , M A G Sprangers 2 , J J B van Lanschot 1 ,
Affiliation  

Background Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard of care for patients with esophageal or junctional cancer, but the long-term impact of nCRT on health-related quality of life (HRQOL) is unknown. The purpose of this study is to compare very long-term HRQOL in long-term survivors of esophageal cancer who received nCRT plus surgery or surgery alone. Patients and methods Patients were randomly assigned to receive nCRT (carboplatin/paclitaxel with 41.4-Gy radiotherapy) plus surgery or surgery alone. HRQOL was measured using EORTC-QLQ-C30, EORTC-QLQ-OES24 and K-BILD questionnaires after a minimum follow-up of 6 years. To allow for examination over time, EORTC-QLQ-C30 and QLQ-OES24 questionnaire scores were compared with pretreatment and 12 months postoperative questionnaire scores. Physical functioning (QLQ-C30), eating problems (QLQ-OES24) and respiratory problems (K-BILD) were predefined primary end points. Predefined secondary end points were global quality of life and fatigue (both QLQ-C30). Results After a median follow-up of 105 months, 123/368 included patients (33%) were still alive (70 nCRT plus surgery, 53 surgery alone). No statistically significant or clinically relevant differential effects in HRQOL end points were found between both groups. Compared with 1-year postoperative levels, eating problems, physical functioning, global quality of life and fatigue remained at the same level in both groups. Compared with pretreatment levels, eating problems had improved (Cohen's d -0.37, P = 0.011) during long-term follow-up, whereas physical functioning and fatigue were not restored to pretreatment levels in both groups (Cohen's d -0.56 and 0.51, respectively, both P < 0.001). Conclusions Although physical functioning and fatigue remain reduced after long-term follow-up, no adverse impact of nCRT is apparent on long-term HRQOL compared with patients who were treated with surgery alone. In addition to the earlier reported improvement in survival and the absence of impact on short-term HRQOL, these results support the view that nCRT according to CROSS can be considered as a standard of care. Trial registration number Netherlands Trial Register NTR487.

中文翻译:

新辅助放化疗对食道癌或结节癌长期幸存者健康相关生活质量的影响:来自随机CROSS试验的结果。

背景技术新辅助放化疗+手术是食道癌或结节癌患者的标准治疗方法,但是nCRT对健康相关生活质量(HRQOL)的长期影响尚不清楚。这项研究的目的是比较接受nCRT加手术或仅接受手术的长期食管癌幸存者的长期HRQOL。患者和方法患者被随机分配接受nCRT(卡铂/紫杉醇联合41.4-Gy放疗)加手术或仅接受手术。在至少随访6年后,使用EORTC-QLQ-C30,EORTC-QLQ-OES24和K-BILD问卷对HRQOL进行了测量。为了允许随时间进行检查,将EORTC-QLQ-C30和QLQ-OES24问卷评分与治疗前和术后12个月的问卷评分进行了比较。物理功能(QLQ-C30),饮食问题(QLQ-OES24)和呼吸问题(K-BILD)是预先定义的主要终点。预定义的次要终点是全球生活质量和疲劳程度(均为QLQ-C30)。结果在中位随访105个月后,有123/368名患者(33%)仍然活着(70 nCRT加手术,仅53例手术)。两组之间在HRQOL终点均未发现统计学上显着或临床相关的差异作用。与术后一年的水平相比,两组的进食问题,身体机能,整体生活质量和疲劳程度均保持在相同水平。与预处理水平相比,长期随访期间进食问题有所改善(Cohen d -0.37,P = 0.011),而两组的身体功能和疲劳均未恢复至预处理水平(Cohen d -0)。分别为56和0.51,均P <0.001)。结论尽管长期随访后身体机能和疲劳仍然减轻,但是与仅接受手术治疗的患者相比,nCRT对长期HRQOL没有明显的不良影响。除了较早报道的生存改善和对短期HRQOL的影响外,这些结果还支持以下观点:根据CROSS的nCRT可被视为护理标准。试用注册号荷兰试用注册号NTR487。除了较早报道的生存改善和对短期HRQOL的影响外,这些结果还支持以下观点:根据CROSS,nCRT可被视为护理标准。试用注册号荷兰试用注册号NTR487。除了较早报道的生存改善和对短期HRQOL的影响外,这些结果还支持以下观点:根据CROSS的nCRT可被视为护理标准。试用注册号荷兰试用注册号NTR487。
更新日期:2018-02-02
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