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Reference values for the EORTC QLQ-C30 in early and metastatic breast cancer.
European Journal of Cancer ( IF 8.4 ) Pub Date : 2019-12-12 , DOI: 10.1016/j.ejca.2019.10.031
Justyna Mierzynska 1 , Mekdes Taye 1 , Madeline Pe 1 , Corneel Coens 1 , Francesca Martinelli 1 , Katarzyna Pogoda 2 , Galina Velikova 3 , Vesna Bjelic-Radisic 4 , Fatima Cardoso 5 , Etienne Brain 6 , Michail Ignatiadis 7 , Martine Piccart 7 , Geertjan Van Tienhoven 8 , Robert Mansel 9 , Hans Wildiers 10 , Andrew Bottomley 1 ,
Affiliation  

BACKGROUND Considering the worldwide incidence of breast cancer (BC) and the importance of health-related quality of life (HRQoL) assessment, there is a growing need to have accurate and up-to-date reference values (RVs). RVs are useful for the design of randomised controlled trials (RCTs) and as benchmarks for comparison of cancer RCTs and health care interventions. This study aimed to provide RVs for the QLQ-C30 in early BC (EBC) and metastatic BC (MBC). General patterns of main results from the EORTC dataset (main dataset) were compared with the PDS dataset (comparison dataset) to see whether they would be consistent across pre-defined covariates. METHODS European Organization for Research and Treatment of Cancer (EORTC) (main dataset) and Project Data Sphere (PDS) (comparison dataset) were searched to identify BC RCTs where baseline HRQoL (before treatment) was assessed with the QLQ-C30. RVs were calculated and stratified by disease stage, age, and when available, performance status (PS), comorbidity and region. RVs were reported using descriptive statistics. RESULTS Data from three EORTC (n = 4115) and three PDS RCTs (n = 1406) were included in the analysis. While EBC patients presented better HRQoL with high baseline functioning scores and low prevalence of symptoms, MBC patients reported worse HRQoL with lower functioning scores and more prevalence of symptoms. In MBC, poor PS and presence of comorbidities reflected worse baseline HRQoL. No consistent differences were found for age and countries. CONCLUSION These up-to-date RVs for the EORTC QLQ-C30 in BC show differences in HRQoL scores between stages, PS, and comorbidities. These findings, supported by an independent dataset, will help the clinical interpretation of scores for BCpatients.

中文翻译:

EORTC QLQ-C30在早期和转移性乳腺癌中的参考值。

背景技术考虑到全世界乳腺癌(BC)的发病率和健康相关的生活质量(HRQoL)评估的重要性,对准确和最新的参考值(RV)的需求日益增长。RV可用于设计随机对照试验(RCT),并可作为比较癌症RCT和医疗保健干预措施的基准。这项研究旨在为早期BC(EBC)和转移性BC(MBC)的QLQ-C30提供RV。将EORTC数据集(主要数据集)的主要结果的一般模式与PDS数据集(比较数据集)进行了比较,以了解它们在预定义的协变量之间是否一致。方法检索了欧洲癌症研究和治疗组织(EORTC)(主要数据集)和项目数据领域(PDS)(比较数据集),以鉴定使用QLQ-C30评估基线HRQoL(治疗前)的BC RCT。根据疾病的阶段,年龄以及表现状态(PS),合并症和区域对RV进行计算和分层。RV是使用描述性统计数据报告的。结果分析中包含了三个EORTC(n = 4115)和三个PDS RCT(n = 1406)的数据。EBC患者表现出较高的HRQoL,基线功能评分较高,症状发生率较低,而MBC患者报告的HRQoL较差,功能评分较低,症状发生率较高。在MBC中,PS差和合并症的存在反映出基线HRQoL较差。没有发现年龄和国家的一致差异。结论BC的EORTC QLQ-C30的这些最新RV表现出各阶段,PS和合并症之间HRQoL评分的差异。这些结果得到独立数据集的支持,将有助于对BC患者的评分进行临床解释。
更新日期:2019-12-12
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