Bascoul-Mollevi C, Gourgou S, Galais M-P, Raoul J-L, Bouché O, Douillard J-Y, Adenis A, Etienne P-L, Juzyna B, Bedenne L, Conroy T
Biometrics Unit - CTD INCa and French National Platform Quality of Life and Cancer, Institut Du Cancer Montpellier, Montpellier, France; Institut de Recherche en Cancérologie de Montpellier INSERM U1194, Montpellier, France.
Biometrics Unit - CTD INCa and French National Platform Quality of Life and Cancer, Institut Du Cancer Montpellier, Montpellier, France.
Eur J Cancer. 2017 Oct;84:239-249. doi: 10.1016/j.ejca.2017.07.038. Epub 2017 Aug 19.
A recent prospective randomised trial did not reveal significant differences in median progression-free survival between two chemoradiotherapy (CRT) regimens for inoperable non-metastatic oesophageal cancer patients. This secondary analysis aimed to describe the impact of CRT on health-related quality of life (HRQOL), physical functioning, dysphagia, fatigue and pain and to evaluate whether baseline HRQOL domains can predict overall survival.
A total of 267 patients were randomly assigned to receive with 50 Gy of radiotherapy in 25 fractions six cycles of FOLFOX or four cycles of fluorouracil and cisplatin on day 1. HRQOL was prospectively assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire version 3.0 with the oesophageal cancer module (QLQ-OES18).
Both groups showed high baseline compliance. Subsequently, compliance reduced to 41% at the 6-month follow-up. Baseline HRQOL scores showed no statistical differences between treatment arms. During treatment, both groups exhibited lower physical and social functioning and increased fatigue and dyspnoea, although dysphagia moderately improved in the fluorouracil-cisplatin arm only (p = 0.047). During follow-up, HRQOL scores revealed no significant differences between chemotherapy regimens. Linear mixed model exhibited a treatment-by-time interaction effect for dysphagia (p = 0.017) with a greater decrease in dysphagia in the fluorouracil-cisplatin group. Time until definitive deterioration analysis showed no significant differences in global HRQOL, functional or main symptom domains. However, time until definitive deterioration was significantly longer for the fluorouracil and cisplatin arm compared with FOLFOX for appetite loss (p = 0.002), QLQ-OES-18 pain (p = 0.008), trouble swallowing saliva (p = 0.011) and trouble talking (p = 0.020).
Analyses of HRQOL scores revealed no statistically significant differences between patients with inoperable non-metastatic oesophageal cancer treated by FOLFOX versus those treated with a fluorouracil-cisplatin regimen as part of definitive CRT.
最近一项前瞻性随机试验未显示，对于无法手术的非转移性食管癌患者，两种放化疗（CRT）方案在无进展生存期的中位数上存在显著差异。这项二次分析旨在描述放化疗对健康相关生活质量（HRQOL）、身体功能、吞咽困难、疲劳和疼痛的影响，并评估基线HRQOL领域是否能预测总生存期。
总共267例患者被随机分配，一组接受25次分割、共50Gy的放疗，同时在第1天接受六个周期的FOLFOX方案，另一组接受四个周期的氟尿嘧啶和顺铂方案。使用欧洲癌症研究与治疗组织核心生活质量问卷第3.0版食管癌模块（QLQ-OES18）对HRQOL进行前瞻性评估。
两组在基线时的依从性都很高。随后，在6个月的随访中，依从性降至41%。基线HRQOL评分在治疗组之间无统计学差异。在治疗期间，两组的身体和社会功能均下降，疲劳和呼吸困难增加，不过仅氟尿嘧啶-顺铂组的吞咽困难有中度改善（p = 0.047）。在随访期间，HRQOL评分显示化疗方案之间无显著差异。线性混合模型显示吞咽困难存在治疗与时间的交互作用（p = 0.017），氟尿嘧啶-顺铂组的吞咽困难下降幅度更大。直至最终恶化时间分析显示，在总体HRQOL、功能或主要症状领域无显著差异。然而，与FOLFOX组相比，氟尿嘧啶和顺铂组在食欲丧失（p = 0.002）、QLQ-OES-18疼痛（p = 0.008）、吞咽唾液困难（p = 0.011）和说话困难（p = 0.020）方面直至最终恶化的时间显著更长。
HRQOL评分分析显示，对于作为确定性CRT一部分接受FOLFOX治疗的无法手术的非转移性食管癌患者与接受氟尿嘧啶-顺铂方案治疗的患者之间，无统计学上的显著差异。
