Quality-of-life reporting in randomized controlled trials shaping the EAU Renal Cell Carcinoma Guidelines

Quality-of-life (QoL) metrics' importance in patient care has been increasingly recognized and has led oncological societies to issue clinical guidances on their collection. We aim to describe how current RCTs shaping the EAU RCC Guidelines collect QoL metrics and how long they report them.

We searched EAU Renal Cell Carcinoma Guidelines' references for phase 3 clinical trials. Data related to if, for how long and how QoL metrics were collected and/or reported were obtained.

Over 35 identified trials, with 16 (46 %) having complete information, being included on our study. Among the analyzed studies, 11 (69 %) were on metastasized/advanced disease setting and 5 (31 %) in adjuvant therapy after surgery; none included QoL as a primary outcome, and 13 (81 %) reported positive QoL results. Regarding timings, all (100 %) studies reported QoL during intervention, and at end of treatment, 9 (56 %) until progression and none (0 %) until death. Median OS was reached in 11 (69 %) studies. Across all studies, the median QoL reporting time was of 7.6 (5.0-12.0) months and the median observation time of 27.1 (22.5-53.1) months. As such, trials reported QoL metrics for a of 28.0 % of the possible time at time of their publications.

We found that only 46 % of RCTs reported on QoL metrics and most of these evaluated QoL during an insufficient timeframe. Most studies in this field are not adequately informing on QoL metrics, even when they are reported.