Hospital Universitario del Río Hortega, Valladolid, Spain.
Universidad de Valladolid, Valladolid, Spain.
Curr Oncol. 2020 Apr;27(2):e100-e105. doi: 10.3747/co.27.5365. Epub 2020 May 1.
In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components.
We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012-2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc.
Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%.
Most clinical trials registered during 2012-2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.
2012 年，通过共识声明定义了 11 项描述晚期癌症临床试验中最佳支持治疗（bsc）的标准。共识包括 15 个关键组成部分。我们的目的是分析涉及晚期癌症患者且至少在一个臂中包含 bsc 的临床试验是否符合标准并包含关键组成部分。
我们回顾了 2012-2018 年在 ClinicalTrials.gov、isrctn（国际标准随机对照试验编号）注册处、欧盟临床试验注册处和国际临床试验注册平台上注册的临床试验。我们仅选择了至少在一个臂中包含 bsc 的晚期癌症患者的 III 期研究。我们描述了试验的特征，以及 bsc 的定义和组成部分。我们分析了试验如何符合标准并采用了 bsc 的关键组成部分。
在检索到的 193 项试验中，只有 64 项符合纳入标准；其中 36 项试验（56%）没有 bsc 的定义。不到 7%的试验甚至包括 8 项 bsc 标准中的 3 项，这些标准被定义为纳入试验设计。此外，试验仅提到了共识定义为基本的 15 个关键组成部分中的 5 个，其中症状管理出现在 22%的试验中，而其他 4 个组成部分出现在不到 8%的试验中。
2012-2018 年期间注册的涉及癌症患者和 bsc 臂的大多数临床试验都没有定义 bsc 概念。因此，这些试验的设计不符合共识建议。
