CheckMate 9ER HRQoL data support first-line nivolumab–cabozantinib in advanced RCC
People receiving nivolumab plus cabozantinib for advanced renal cell carcinoma (RCC) report less decline in health-related quality of life (HRQoL) during treatment than those given sunitinib, show data from the phase 3 CheckMate 9ER trial.
The primary analysis of the study showed that first-line nivolumab plus cabozantinib significantly improves progression-free survival (PFS) relative to sunitinib.
When taken together with the current analysis of patient-reported outcomes (PROs), David Cella (Northwestern University, Chicago, Illinois, USA) and co-investigators say that the data “further support the use of nivolumab plus cabozantinib over sunitinib.”
The study included 651 individuals with treatment-naïve advanced RCC with a clear-cell component who were randomly assigned to receive nivolumab 240 mg every 2 weeks plus cabozantinib 40 mg daily (n=323), or to receive sunitinib 50 mg daily for 4 weeks in 6-week cycles (n=328).
At baseline, the patient-reported symptom burden was low in both groups, with mean Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) disease-related symptoms version 1 scores of 30.24 and 30.06 points in the combination and monotherapy arms, respectively.
The researchers report in The Lancet Oncology that, during a median 23.5 months of follow-up, “patients receiving combination nivolumab plus cabozantinib treatment experienced maintenance or improvement in PRO scores, while those receiving sunitinib experienced a decline.”
The least-squares mean change from baseline for nivolumab plus cabozantinib versus sunitinib was 2.38 points for FKSI-19 total score and 1.33 points for FKSI-19 disease-related symptoms version 1. The difference was 3.48 points for the three-level EQ-5D visual analog scale (EQ-5D-3L VAS), which describes global health status, and 0.04 points for the EQ-5D-3L UK utility index, which assesses the societal value of a respondent’s health state. In all cases, the differences were nominally significant in favor of the combination therapy.
Cella and team also found that the median time to first deterioration in FKSI-19 total score was significantly longer with nivolumab plus cabozantinib than with sunitinib, at 6.24 versus 3.48 months, as was the time to first deterioration of EQ-5D-3L VAS (13.86 vs 4.67 months).
The investigators note that fatigue, pain, weight loss, appetite, and sleep-related symptoms were the biggest contributors to deterioration in PROs in post-hoc analyses.
“With the advent of multiple efficacious options for renal cell carcinoma, selecting the optimal first-line therapy can be challenging,” Cella et al remark.”
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