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首页> 外文期刊>Thoracic cancer. >Trends in endpoint selection and result interpretation in advanced non‐small cell lung cancer clinical trials published between 2000 and 2012: A retrospective cohort study
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Trends in endpoint selection and result interpretation in advanced non‐small cell lung cancer clinical trials published between 2000 and 2012: A retrospective cohort study

机译：终点选择的趋势和结果解释在2000年至2012年期初发布的晚期非小细胞肺癌临床试验：回顾性队列研究

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The objective of this review was to investigate trends in clinical trial design, specifically, the primary outcomes used, interpretation of results, and the magnitude of the benefits described in phase III controlled clinical trials in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). Seventy-six trials published between 2000 and 2012 were selected from a total of 122 identified in a structured search. Overall survival (OS) was evaluated as the primary study endpoint in 50 (65.8%) trials, followed by progression-free survival (PFS) in 15 (19.7%), and other variables, such as toxicity, quality of life (QoL), and response rate in 11 (14.5%). Ten (66.7%) out of 15 clinical trials using PFS as the primary endpoint were published between 2010 and 2012. Median overall survival (mOS) was 9.90?months (interquartile range: 3.5) with an increase of 0.384?months per year of publication (P 0.001). A statistically significant improvement in mOS was obtained in only 13 (18.8%) trials. A total of 41 (53.9%) studies concluded that the result was positive. Of these, only 16 (39.1%) showed a statistically significant benefit in OS. QoL was assessed in 46 trials (60.5%) and of these, 10 (21.7%) reported significant improvements. These findings raise important questions about how clinical benefits are measured in clinical trials in advanced NSCLC. Appropriate clinically relevant outcome variables should be established and validated, and post-marketing studies should be requested by regulatory authorities to ensure meaningful clinical benefits in OS and QoL. ? 2019 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.
机译：本综述的目的是调查临床试验设计的趋势，具体地，使用的主要结果，对结果的初级结果以及在第一线治疗前进的患者中描述的临床临床试验中描述的益处的程度小细胞肺癌（NSCLC）。 2000年至2012年间发布的七十六项试验选自在结构化搜索中的总共122名。整体存活（OS）被评估为50（65.8％）试验中的主要研究终点，其次是15（19.7％）和其他变量（如毒性，生活质量）（如毒性）的进展存活率（PFS） ，11（14.5％）的响应率。在2010年至2012年间，使用PFS出版的15名临床试验中的十（66.7％）。中位数总生存（MOS）为9.90？月（四分位数：3.5），每年增加0.384个月（P <0.001）。仅在13（18.8％）试验中获得MOS的统计学上显着的改进。共有41项（53.9％）的研究得出结论，结果是阳性的。其中，只有16个（39.1％）在OS中显示出统计学上显着的益处。 QoL在46项试验中评估（60.5％），其中10例（21.7％）报告了显着的改进。这些发现提出了关于临床效益如何在高级NSCLC中的临床试验中测量的重要问题。应建立和验证适当的临床相关结果变量，监管机构应要求营销后的研究，以确保在OS和QOL中有意义的临床效益。 ？ 2019年的作者。中国肺部肿瘤集团和约翰瓦里和儿子澳大利亚发表的胸癌

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