Aims: 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. Methods: 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. Results: In 13/25 publications, QoL was not listed among the end points, with secondary publications dedicated to QoL present in a minority of cases. Conclusions: QoL was not included among the end points of a large percentage of CTs. Implementing the inclusion of QoL represents an urgent need.
Lay abstract Recent years have seen growing attention toward quality of life (QoL) in medical oncology clinical trials and statistical measurement of this aspect of cancer treatment. Nonetheless, although most clinicians and researchers agree that QoL should represent a fundamental component of clinical trials, the inclusion of QoL results is still inadequate, and our systematic review confirms that implementing the inclusion of QoL remains an urgent need.
Future oncology (London, England). 2021 Apr 21 [Epub ahead of print]
Alessandro Rizzo, Veronica Mollica, Filippo Gustavo Dall'Olio, Angela Dalia Ricci, Ilaria Maggio, Andrea Marchetti, Matteo Rosellini, Matteo Santoni, Andrea Ardizzoni, Francesco Massari
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni15, Bologna, 40138, Italy., Department of Medical Oncology, Azienda USL of Bologna, Bologna, 40139, Italy., Oncology Unit, Macerata Hospital, Macerata, 62100, Italy.