Patient-Reported Outcomes With Nivolumab Plus Ipilimumab vs Sunitinib in Advanced Renal Cell Carcinoma


Key Points

  • Significant improvements in patient-reported outcomes were observed for nivolumab/ipilimumab vs sunitinib.
  • Nivolumab/ipilimumab was associated with reduced risk of deterioration in health-related quality of life measures. 

As reported in The Lancet Oncology by Cella et al, patient-reported outcomes were better with nivolumab plus ipilimumab vs sunitinib in the phase III CheckMate 214 trial among patients with intermediate- or poor-risk advanced renal cell carcinoma. The ongoing trial showed significantly improved overall survival—but not progression-free survival—with nivolumab plus ipilimumab in this patient population.

Study Details

In the open-label trial, patients with previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component from 175 sites in 28 countries were randomly assigned between October 2014 and February 2016 to receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab 3 mg/kg every 2 weeks or sunitinib 50 mg/day for 4 weeks of each 6-week cycle. Among the 1,096 randomized patients, 847 (77%) were at intermediate or poor risk, including 425 in the nivolumab/ipilimumab group and 422 in the sunitinib group.

Patient-reported outcomes, an exploratory endpoint, were assessed using the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G), and EuroQol five dimensional three level (EQ-5D-3L; five domains = mobility, self-care, usual activities, pain and discomfort, and depression and anxiety).  

Patient-Reported Outcomes

Median follow-up was 25.2 months. At week 103, significant improvements in the nivolumab/ipilimumab group vs sunitinib group were observed for FKSI-19 total score (mean change = +4.00 vs −3.14 (P < .0001) and FACT-G total score (mean change = +4.77 vs −4.32 (P = .0005), with no significant difference observed in EQ-5D-3L visual analogue rating scale score (mean change = +10.07 vs +6.40, P = .45).  Significant differences in favor of nivolumab/ipilimumab were observed in 4 of 5 FKSI-19 domains (disease-related symptoms, physical disease-related symptoms, treatment side-effects, and functional well-being) and FACT-G physical and functional well-being domains.

Nivolumab/ipilimumab was associated with reduced risk in deterioration in FKSI-19 total score (hazard ratio [HR] = 0.54, 95% confidence interval [CI] = 0.46–0.63), FACT-G total score (HR = 0.63, 95% CI = 0.52–0.75), and EQ-5D-3L visual analogue rating scale score (HR = 0.75, 95% CI = 0.63–0.89).

The investigators concluded, “Nivolumab plus ipilimumab leads to fewer symptoms and better [health-related quality of life] than sunitinib in patients at intermediate- or poor-risk with advanced renal cell carcinoma. These results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib comes with the additional benefit of improved [health-related quality of life].”

David Cella, PhD, of the Department of Medical Social Sciences, Northwestern University, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by Bristol-Myers Squibb and ONO Pharmaceutical. The study authors’ full disclosures can be found at

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.