medwireNews: Patients with previously untreated intermediate- or poor-risk advanced renal cell carcinoma (RCC) derive greater health-related quality of life (HRQoL) benefits from nivolumab plus ipilimumab than from sunitinib, CheckMate 214 data show.
David Cella (Northwestern University, Chicago, Illinois, USA) and co-investigators say their findings “lend further support to the benefit-risk profile of nivolumab plus ipilimumab over sunitinib as a new standard of care for first-line, advanced renal cell carcinoma.”
Cella and team explain that efficacy results from the ongoing phase III CheckMate 214 trial showed a significantly reduced risk for death and a significantly higher objective response rate with nivolumab plus ipilimumab than with sunitinib in previously untreated patients with intermediate or poor risk advanced RCC.
In the current analysis, the researchers demonstrated that patient-reported outcomes (PROs), assessed using the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), the Functional Assessment of Cancer Therapy-General (FACT-G), and EuroQol five dimensional three level (EQ-5D-3L) instruments, were consistently higher among the 425 patients who received nivolumab plus ipilimumab than among the 422 who received sunitinib.
Specifically, the FKSI-19 total score, which measures tumor specific outcomes, improved by a mean 4.00 points from baseline to week 103 with nivolumab plus ipilimumab but declined by 3.14 points with sunitinib, a difference that was statistically significant between the two treatment groups.
The between-group difference was also significant for the FACT-G, with a mean improvement of 4.77 points observed at week 103 among the patients who received nivolumab plus ipilimumab versus a deterioration of 4.32 points among those who received sunitinib.
For the EQ-5D-3L, which measures general health status, there was generally a greater mean improvement with nivolumab plus ipilimumab than with sunitinib throughout the study, but the difference was not significant at week 103 (10.07 vs 6.40).
When each HRQoL measure was broken down into its specific domains, the team observed significant improvements in four of the five FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional wellbeing, but not emotional disease-related symptoms) and two of the four FACT-G domains (physical and functional wellbeing but not family or emotional wellbeing).
Writing in The Lancet Oncology, Cella and co-authors note that more patients receiving nivolumab plus ipilimumab than sunitinib discontinued treatment due to drug-related adverse events, which raised “some concerns regarding the safety and tolerability of nivolumab plus ipilimumab despite the demonstrated superior efficacy.”
In spite of this, “nivolumab plus ipilimumab had a more favourable effect on HRQoL than sunitinib did, suggesting a positive overall risk-benefit profile for the combination treatment,” they remark.
The researchers conclude: “We believe these results will be important in clinical treatment decisions for patients with advanced renal cell carcinoma.”
By Laura Cowen
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