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Updated: Aug 6, 2025
A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Patient-reported outcomes in metastatic renal cell carcinoma trials using combinations versus sunitinib as first-line
Kyle Nolla1, David J Benjamin2, David Cella3
1Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. kylenolla@northwestern.edu.
Abstract:
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.
Insights
New immunotherapy combinations significantly improve health-related quality of life (HRQoL) for metastatic renal cell carcinoma (mRCC) patients compared to standard treatments. Standardized collection of patient-reported outcome measures (PROMs) is crucial for future research.
Area of Science:
- Oncology
- Clinical Trials
- Health-Related Quality of Life Research
Background:
- Metastatic renal cell carcinoma (mRCC) treatments have evolved with new immunotherapy options.
- While clinical outcomes improve, the impact on patients' health-related quality of life (HRQoL) requires thorough evaluation.
- Current patient-reported outcome measures (PROMs) for HRQoL lack standardization, hindering comparative analysis.
Purpose of the Study:
- To evaluate and compare the HRQoL outcomes of various immunotherapy combinations versus standard tyrosine kinase inhibitor (TKI) monotherapy in mRCC.
- To identify immunotherapy regimens that demonstrate superior HRQoL benefits for mRCC patients.
- To highlight the need for standardized PROMs in clinical trials for reliable HRQoL assessment.
Main Methods:
- Analysis of HRQoL data from six clinical trials involving immunotherapy combinations in mRCC.
- Comparison of HRQoL results between treatments like nivolumab plus cabozantinib, atezolizumab plus bevacizumab, nivolumab plus ipilimumab, and lenvatinib plus pembrolizumab against sunitinib.
- Assessment of potential design flaws in trials that reported no HRQoL difference.
Main Results:
- Nivolumab plus cabozantinib (CheckMate 9ER) and atezolizumab plus bevacizumab (IMmotion151) significantly outperformed sunitinib in HRQoL.
- Nivolumab plus ipilimumab (CheckMate 214) and lenvatinib plus pembrolizumab (CLEAR) generally showed better HRQoL than sunitinib.
- Two trials (JAVELIN Renal 101, KEYNOTE-426) with potential design flaws reported no HRQoL difference.
Conclusions:
- Certain immunotherapy combinations offer significant HRQoL advantages for mRCC patients over sunitinib.
- Standardized PROMs and rigorous trial design are essential for accurate and comparable HRQoL assessment in mRCC clinical trials.
- Future research must prioritize robust HRQoL data collection and reporting to guide holistic treatment decisions.
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