There was an association between health-related quality of life (HRQoL) and clinical outcomes in patients with advanced renal cell carcinoma (RCC) in the CheckMate 214 study, according to an analysis presented at the 2022 ASCO Annual Meeting (Abstract 4502).
CheckMate 214 was a phase-3 clinical trial comparing treatment with sunitinib versus nivolumab plus ipilimumab in patients with advanced RCC with intermediate/poor-risk disease. The trial showed superior overall survival and response benefits with the nivolumab/ipilimumab combination compared with sunitinib.
David Cella, PhD, of Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, presented results of an analysis looking at the direct association between HRQoL and clinical outcomes among patients with intermediate/poor-risk disease in the nivolumab/ipilimumab (425 patients) and sunitinib (422 patients) arms.
HRQoL was assessed using the FKSI-19 (Total Score and Disease Related Symptoms [DRS]). Cella and colleagues did three separate analyses looking at changes in individual item scores from baseline to last assessment prior to progression, multivariable Cox regression to evaluate prognostic significance of baseline and time-dependent HRQoL scores, and the association between HRQoL change status and overall survival using a landmark analysis at the 6-month landmark.
They found that items related to fatigue and perceived bother of the side effects of treatment had the largest percentage of patients worsening prior to progression.
In both the baseline and time-dependent HRQoL analyses, overall survival was associated with both HRQoL measures. Specifically, higher baseline scores were associated with reduced risk of death (hazard ratio [HR] for FKSI-19 Total Score and DRS=0.83; 95% CI, 0.80-0.87 and 0.80; 95% CI, 0.76-0.84).
Each 5-point increase in the FKSI-19 Total Score and each 3-point increase in the DRS score was associated with a 31% decreased risk of death (P<.01), the researchers reported in the abstract.
HRQoL change status at the 6-month landmark analysis was also associated with survival. The researchers found that 301 patients had improvement on maintenance of HRQoL. Those with improved or stable HRQoL had a 52% reduction in risk for death compared with those who had worsened HRQoL (HR=048; 95% CI, 0.39-0.59).
Based on these results, Cella and colleagues concluded that baseline HRQoL scores may be a potential predictor of survival in advanced RCC.