Department of Oncology-Hematology, University Hospital of Modena, Modena, Italy; Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC), Italy.
Department of Bio-Statistics, RCCS Regina Elena National Cancer Institute, Italy.
Breast. 2021 Oct;59:232-238. doi: 10.1016/j.breast.2021.07.008. Epub 2021 Jul 12.
In recent years, the number of trials incorporating health-related quality of life (HRQoL) data has increased. The impact of HRQoL on regulatory decision making in the European context and on clinical practice is not well established. We conducted an analysis of the role of QoL data extracted from the clinical trials of the drugs approved for hormone receptor positive/HER2-negative advanced/metastatic breast cancer (mBC). The results from the HRQoL were collected and a meta-analysis was performed to evaluate the impact of experimental drugs compared to standard treatments. The results showed a non-detrimental effect in HRQoL from the new treatments. As regards the approval process, from an examination of the European Medicine Agency (EMA) documents, HRQoL was reported nonextensively and contained and discussed in the European assessment reports (EPARs) for eleven trials in the approval process and cited in three cases in the EPARs and summary of medicinal product characteristics (SmPC). An effort should be made by all the stakeholders to increase the visibility of the HRQoL results in order to allow increased consideration in the approval process to make QoL data more easily and visibly available for the clinician and the patients. The evaluation should be reflected in the SmPC in order to increase the amount of information provided to the physician.
近年来，纳入健康相关生活质量（HRQoL）数据的试验数量有所增加。HRQoL 对欧洲监管决策和临床实践的影响尚未得到充分确立。我们分析了从批准用于激素受体阳性/HER2 阴性晚期/转移性乳腺癌（mBC）的药物临床试验中提取的 QoL 数据的作用。收集了 HRQoL 的结果，并进行了荟萃分析，以评估与标准治疗相比实验药物的影响。结果表明，新治疗方法对 HRQoL 没有不利影响。关于批准程序，从对欧洲药品管理局（EMA）文件的审查来看，HRQoL 的报告并不广泛，在批准程序中的十一项试验的欧洲评估报告（EPAR）中包含并讨论了该报告，并在三份 EPAR 和药品特性摘要（SmPC）中引用了该报告。所有利益相关者都应努力提高 HRQoL 结果的可见度，以便在批准过程中更多地考虑这些结果，使 QoL 数据更容易为临床医生和患者获得。评估应反映在 SmPC 中，以增加向医生提供的信息量。
