Patient-reported outcomes in metastatic renal cell carcinoma trials using combinations versus sunitinib as first-line treatment.

Over the past 5 years, several new immunotherapy treatments have been tested for metastatic renal cell carcinoma (mRCC). Clinical trials assessing combinations of different immunotherapies, or of an immunotherapy with a tyrosine kinase inhibitor (TKI), have reported improved clinical outcomes compared with the standard of care - that is, treatments using TKIs alone. However, to understand the holistic impact of new treatments on patients, physicians must also consider effects on health-related quality of life (HRQoL). As patient-reported outcome measures (PROMs) on HRQoL are often treated as a secondary outcome in clinical trials, their collection and reporting are non-standardized and, therefore, difficult to compare and interpret. However, results from six clinical trials indicate that two immunotherapy treatments overwhelmingly outperform sunitinib in HRQoL measurements: nivolumab plus cabozantinib (CheckMate 9ER) and atezolizumab plus bevacizumab (IMmotion151). An additional two treatments generally outperform sunitinib: nivolumab plus ipilimumab (CheckMate 214) and lenvatinib plus pembrolizumab (CLEAR). Of three studies that reported no difference from sunitinib, two suffered design flaws that might have obscured HRQoL benefits (JAVELIN Renal 101 and KEYNOTE-426). To ensure future HRQoL data are of the highest quality and comparable across trials, future studies should adopt best practices for the design, analysis and reporting of PROMs.