Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni15, Bologna, 40138, Italy.
Department of Medical Oncology, Azienda USL of Bologna, Bologna, 40139, Italy.
Future Oncol. 2021 Jul;17(20):2671-2681. doi: 10.2217/fon-2021-0069. Epub 2021 Apr 21.
Quality of life (QoL) assessment is frequently not included among the end points of clinical trials (CTs) on renal cell carcinoma. Herein we aimed to describe the assessment and reporting of QoL in Phase II and Phase III CTs published between 2010 and 2020. A total of 25 CTs were included; 76% of trials included were conducted in metastatic renal cell carcinoma patients, while 20% of studies evaluated adjuvant systemic treatments. In 13/25 publications, QoL was not listed among the end points, with secondary publications dedicated to QoL present in a minority of cases. QoL was not included among the end points of a large percentage of CTs. Implementing the inclusion of QoL represents an urgent need.
生活质量（QoL）评估通常不包括在肾癌的临床试验（CT）终点中。在此，我们旨在描述 2010 年至 2020 年期间发表的 II 期和 III 期 CT 中 QoL 的评估和报告。共纳入 25 项 CT；76%的试验包括转移性肾细胞癌患者，而 20%的研究评估了辅助全身治疗。在 25 篇出版物中，有 13 篇未将 QoL 列为终点，仅有少数情况下会有专门针对 QoL 的二次出版物。很大一部分 CT 未将 QoL 作为终点。实施 QoL 的纳入是当务之急。
Future Oncol. 2021-2
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