肺癌患者生活质量分析：2012 年至 2018 年间发表的 III 期临床试验的系统评价。
Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018.
机构信息
Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, TO, Italy.
Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Torino, Italy.
出版信息
Lung Cancer. 2020 Jan;139:47-54. doi: 10.1016/j.lungcan.2019.10.022. Epub 2019 Oct 31.
OBJECTIVES
We previously reported that quality of life (QoL) is not included among trial endpoints and QoL results are underreported in a significant proportion of phase III oncology trials. Here we describe QoL adoption, reporting and methodology of QoL analysis in lung cancer trials.
MATERIALS AND METHODS
We selected all primary publications of lung cancer phase III trials assessing anticancer drugs published between 2012 and 2018 by 11 major journals.
RESULTS
122 publications were included. In 39 (32.0%) publications, QoL was not listed among endpoints: in 10/17 (58.8%) early stage/locally advanced NSCLC, in 15/54 (27.8%) first-line of advanced NSCLC; in 10/41 (24.4%) second and further lines of advanced NSCLC, in 4/10 (40.0%) SCLC. Proportion of trials not including QoL was similar over time: 32.9% publications in 2012-2015 vs. 30.6% in 2016-2018. Out of 83 trials including QoL among endpoints, QoL results were absent in 36 primary publications (43.4%). Proportion of trials without QoL results in primary publication increased over time (30.6% 2012-2015 vs. 61.8% 2016-2018, p = 0.005). Overall, QoL data were not available in 75/122 (61.5%) primary publications, due to the absent endpoint or unpublished results. QoL data were lacking in 48/68 (70.6%) publications of trials with overall survival as primary endpoint, 27/54 (50.0%) with other primary endpoints and 28/54 (51.9%) publications with a positive result. For trials including QoL among endpoints but lacking QoL results in primary publication, probability of secondary publication was 6.3%, 30.1% and 49.8% after 1, 2 and 3 years respectively, without evidence of improvement comparing 2012-2015 vs. 2016-2018.
CONCLUSION
QoL is not assessed or published in many phase III lung cancer trials, a setting where QoL value should be highly considered, due to high symptom burden and generally limited life expectancy. Timely inclusion of results in primary publications is worsening in recent years.
目的
我们之前曾报道过，生活质量（QoL）并不包含在试验终点中，而且在很大一部分 III 期肿瘤学试验中，QoL 结果的报告率很低。在此，我们描述了肺癌试验中 QoL 的采用、报告和分析方法。
材料和方法
我们选择了 11 种主要期刊在 2012 年至 2018 年期间发表的所有原发性肺癌 III 期试验的主要出版物。
结果
共纳入 122 篇出版物。在 39 篇（32.0%）出版物中，QoL 未被列为终点之一：在 10/17（58.8%）早期/局部晚期 NSCLC 中，在 15/54（27.8%）晚期 NSCLC 一线治疗中；在 10/41（24.4%）晚期二线及进一步治疗中，在 4/10（40.0%）小细胞肺癌中。随着时间的推移，未纳入 QoL 的试验比例相似：2012-2015 年有 32.9%的出版物，2016-2018 年有 30.6%。在 83 项将 QoL 作为终点的试验中，36 篇主要出版物（43.4%）未报告 QoL 结果。在主要出版物中未报告 QoL 结果的试验比例随着时间的推移而增加（2012-2015 年为 30.6%，2016-2018 年为 61.8%，p=0.005）。总体而言，75/122（61.5%）篇主要出版物中没有 QoL 数据，原因是终点缺失或结果未发表。在以总生存为主要终点的 68 项试验中有 48/68（70.6%）的出版物缺乏 QoL 数据，在其他主要终点的 54 项试验中有 27/54（50.0%）的出版物缺乏 QoL 数据，在有阳性结果的 54 项试验中有 28/54（51.9%）的出版物缺乏 QoL 数据。对于将 QoL 作为终点纳入试验但在主要出版物中未报告 QoL 结果的试验，在 1、2 和 3 年后二次发表的可能性分别为 6.3%、30.1%和 49.8%，与 2012-2015 年相比，2016-2018 年并无改善迹象。
结论
在许多 III 期肺癌试验中，并未评估或报告生活质量，而在这种情况下，由于症状负担高且总体预期寿命有限，生活质量的价值应该得到高度重视。近年来，及时将结果纳入主要出版物的情况有所恶化。
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