Identification of key symptoms impacting HRQOL in advanced renal cell carcinoma: nivolumab plus cabozantinib versus sunitinib in CheckMate 9ER
Cristiane Bergerot, Shengsheng Yu, Min Yang, Bruno Martins, Mengtian Du, Jose Perez Torrealba, Tasha Hall, Navendu Samant, Robert J Motzer, David CellaAbstract
Background
Nivolumab plus cabozantinib demonstrated significantly better clinical and patient-reported outcomes (PROs) compared with sunitinib as first-line therapy for advanced renal cell carcinoma (aRCC) in CheckMate 9ER. This post-hoc analysis identified key factors contributing to improvements in health-related quality of life (HRQOL) in these patients.
Materials and Methods
Mediation analyses were conducted using first-year CheckMate 9ER data to delineate treatment effects as reflected by HRQOL improvements measured with the EuroQoL 5-Dimension 3-Level questionnaire (EQ-5D-3L) and 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) Functional Well-Being Subscale (FKSI-FWB). The incremental benefits of nivolumab plus cabozantinib over sunitinib were partitioned into mediated effects through symptom and emotional well-being improvements (FKSI-19 scales).
Results
Nivolumab plus cabozantinib (n=323) resulted in significantly greater improvement in EQ-5D utility versus sunitinib (n=328; difference=0.08 [95% confidence interval [CI], 0.05–0.12]) and numerically greater FKSI-FWB improvement (difference=0.22 [95% CI, −0.19 to 0.63]), both primarily driven by greater reductions in fatigue, pain, shortness of breath, and cough, and improvements in emotional well-being (all P<0.05). Reduced fatigue was the largest contributor to gains in both scales (24.0% and 21.1% of total mediated effect, respectively); improvement in emotional well-being accounted for 5.0% and 17.2% of the total mediated effect.
Conclusion
These findings highlight underlying pathways contributing to HRQOL improvement in patients with aRCC receiving nivolumab plus cabozantinib. These data suggest that treatment with nivolumab plus cabozantinib is associated with an improvement in symptoms that can be quantified using PRO measures, supporting the utility of incorporating patient-centric outcomes into treatment decision making.
ClinicalTrials.gov
NCT03141177