Koller Michael, Warncke Sophie, Hjermstad Marianne J, Arraras Juan, Pompili Cecilia, Harle Amelie, Johnson Colin D, Chie Wei-Chu, Schulz Christian, Zeman Florian, van Meerbeeck Jan P, Kuliś Dagmara, Bottomley Andrew
Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
Regional Centre for Excellence in Palliative Care, Department of Oncology, Oslo University Hospital and European Palliative Care Research Centre, Department of Cancer and Molecular Medicine, Norwegian University of Science and Technology, Norway.
Cancer. 2015 Dec 15;121(24):4300-23. doi: 10.1002/cncr.29682. Epub 2015 Oct 9.
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) covers 13 typical symptoms of lung cancer patients and was the first module developed in conjunction with the EORTC core quality-of-life (QL) questionnaire. This review investigates how the module has been used and reported in cancer clinical trials in the 20 years since its publication. Thirty-six databases were searched with a prespecified algorithm. This search plus an additional hand search generated 770 hits, 240 of which were clinical studies. Two raters extracted data using a coding scheme. Analyses focused on the randomized controlled trials (RCTs). Of the 240 clinical studies that were identified using the LC13, 109 (45%) were RCTs. More than half of the RCTs were phase 3 trials (n = 58). Twenty RCTs considered QL as the primary endpoint, and 68 considered it as a secondary endpoint. QL results were addressed in the results section of the article (n = 89) or in the abstract (n = 92); and, in half of the articles, QL results were presented in the form of tables (n = 53) or figures (n = 43). Furthermore, QL results had an impact on the evaluation of the therapy that could be clearly demonstrated in the 47 RCTs that yielded QL differences between treatment and control groups. The EORTC QLQ-LC13 fulfilled its mission to be used as a standard instrument in lung cancer clinical trials. An update of the LC13 is underway to keep up with new therapeutic trends and to ensure optimized and relevant QL assessment in future trials.
欧洲癌症研究与治疗组织(EORTC)肺癌生活质量问卷-13(QLQ-LC13)涵盖了肺癌患者的13种典型症状,是与EORTC核心生活质量(QL)问卷联合开发的首个模块。本综述调查了该模块自发表以来20年在癌症临床试验中的使用和报告情况。使用预先指定的算法搜索了36个数据库。该搜索加上额外的手工搜索共产生770条命中记录,其中240条为临床研究。两名评分者使用编码方案提取数据。分析重点关注随机对照试验(RCT)。在使用LC13识别出的240项临床研究中,109项(45%)为RCT。超过一半的RCT为3期试验(n = 58)。20项RCT将QL作为主要终点,68项将其作为次要终点。QL结果在文章的结果部分(n = 89)或摘要(n = 92)中有所提及;并且,在一半的文章中,QL结果以表格(n = 53)或图表(n = 43)的形式呈现。此外,QL结果对治疗评估产生了影响,这在47项治疗组与对照组之间出现QL差异的RCT中得到了明确证明。EORTC QLQ-LC13完成了其作为肺癌临床试验标准工具的使命。目前正在对LC13进行更新,以跟上新的治疗趋势,并确保在未来试验中进行优化且相关的QL评估。
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