Van Der Weijst Lotte, Lievens Yolande, Schrauwen Wim, Surmont Veerle
Department of Radiotherapy-Oncology, Ghent University Hospital, Ghent, Belgium.
Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
Front Oncol. 2019 Aug 12;9:715. doi: 10.3389/fonc.2019.00715. eCollection 2019.
The majority of lung cancer patients are diagnosed with advanced non-small cell lung cancer (NSCLC), the bulk of which receive palliative systemic treatment with the goal to provide effective symptom palliation and safeguard health-related quality of life (HRQoL). Advanced NSCLC trials with HRQoL endpoints face methodological constraints limiting interpretability. We provide a comprehensive overview of recent clinical trials evaluating the impact of systemic therapies on HRQoL in advanced NSCLC, focusing on the methodological quality, with the ultimate goal to improve interpretation, comparison and reporting of HRQoL data. A systematic literature review was performed. Prospective studies published over the last decade evaluating the impact of systemic treatments on HRQoL in advanced NSCLC were included. Methodological quality of HRQoL reporting was assessed with the CONSORT-PRO extension. Hundred-twelve manuscripts describing 85 trials met all criteria. No formal conclusion can be drawn regarding the impact on HRQoL of different treatments. We report an important variety in methodological quality in terms of definitions of HRQoL, missing data points, lack of standardization of analyzing and presenting HRQoL and no standard follow-up time. The quality of HRQoL data reporting varies substantially between studies but improves over time. This review shows that in the heterogeneous landscape of trials addressing HRQoL in advanced stage NSCLC. Methodology reporting remains generally poor. Adequate reporting of HRQoL outcome data is equally important to support clinical decision-making as to correctly inform health policy regarding direct approval and reimbursement of the new drugs and combinations that will come online.
大多数肺癌患者被诊断为晚期非小细胞肺癌（NSCLC），其中大部分接受姑息性全身治疗，目的是有效缓解症状并保障健康相关生活质量（HRQoL）。以HRQoL为终点的晚期NSCLC试验面临方法学上的限制，影响了结果的可解释性。我们全面概述了近期评估全身治疗对晚期NSCLC患者HRQoL影响的临床试验，重点关注方法学质量，最终目标是改善HRQoL数据的解释、比较和报告。我们进行了一项系统的文献综述。纳入了过去十年发表的评估全身治疗对晚期NSCLC患者HRQoL影响的前瞻性研究。使用CONSORT-PRO扩展版评估HRQoL报告的方法学质量。112篇描述85项试验的手稿符合所有标准。关于不同治疗对HRQoL的影响无法得出正式结论。我们报告了在HRQoL定义、缺失数据点、HRQoL分析和呈现缺乏标准化以及无标准随访时间方面方法学质量存在重要差异。HRQoL数据报告的质量在不同研究之间差异很大，但随时间有所改善。本综述表明，在晚期NSCLC中针对HRQoL的试验的异质性环境中，方法学报告总体上仍然较差。充分报告HRQoL结果数据对于支持临床决策以及正确告知卫生政策有关即将上市的新药和联合用药的直接批准和报销同样重要。
