Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Quality of life in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214: updated results


30 Sep 2019


Poster Display session 3


David Cella


Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249


D. Cella1, B. Escudier2, C. Ivanescu3, M. Mauer4, J. Lord-Bessen5, K. Gooden6

Author affiliations

  • 1 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 60611 - Chicago/US
  • 2 Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 3 Statistics, IQVIA, 181 - Herikerbergweg/NL
  • 4 Oncology Clinical Development, Bristol-Myers Squibb, 08648 - Lawrenceville/US
  • 5 Health Economics Outcomes Research, Bristol-Myers Squibb, 08648 - Princeton/US
  • 6 Ww Heor, Bristol-Myers Squibb, 08540 - Princeton/US



The primary analysis of health-related quality of life (HRQoL) from CheckMate 214 have been published (Cella et al. Lancet Oncol. 2019). Nivolumab + ipilimumab (N+I) led to superior overall survival (OS) (HR: 0.63; p < 0.001) and more favorable HRQoL than sunitinib (S) as 1st-line treatment for intermediate/poor (I/P)-risk patients (pts) with aRCC. We report herein the HRQoL analyses from the 30-month follow-up.


Pts were randomized 1:1 to receive N 3 mg/kg + I 1 mg/kg every 3 wk for 4 doses then N 3 mg/kg every 2 wk, or S 50 mg/d orally for 4 wk (6-wk cycle). HRQoL was assessed on day 1 of wks 1 and 4 of the first 2 cycles, on day 1 of wks 1 and 5 of the next 2 cycles and on day 1 of wk 1 of subsequent cycles. An exploratory HRQoL analysis was conducted using the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G) and EQ-5D instruments. The analyses included mixed-model repeated measures (MMRM) for change from baseline (BL) at 145 wks (while on-treatment), and time to deterioration (TTD).



951P MMRM analysis (treatment differences at week 145) and time to deterioration for FKSI-19

DomainLS Mean difference N+I vs S [95% CI]LS Mean difference N+I vs S [95% CI]Time to deterioration (months) HR [95% CI]Time to deterioration (months) HR [95% CI]
AllIntermediate / Poor riskAllIntermediate / Poor risk
Total2.99 [0.92; 5.06]a4.24 [1.38; 7.09]a0.54 [0.47; 0.63]a0.54 [0.46; 0.63]a
DRS0.83 [-0.15; 1.82]1.18 [-0.20; 2.56]0.64 [0.55; 0.74]a0.66 [0.56; 0.79]a
DRS-Physical1.69 [0.33; 3.05]a2.49 [0.58; 4.40]a0.57 [0.49; 0.67]a0.58 [0.49; 0.69]a
DRS-Emotional0.23 [-0.04; 0.49]0.10 [-0.26; 0.46]0.90 [0.74; 1.09]0.90 [0.73; 1.13]
Treatment side effects0.73 [0.26; 1.20]a1.01 [0.36; 1.65]a0.42 [0.36; 0.49]a0.45 [0.38; 0.53]a
Functional well-being0.47 [-0.23; 1.18]0.75 [-0.22; 1.72]0.76 [0.66; 0.88]a0.77 [0.66; 0.91]a

P < 0.05 CI, confidence interval; DRS, disease-related symptoms; HR, hazard ratio; LS, least square. A positive LS Mean favors N+I vs S. A HR < 1 favor N+I vs S.

1096 pts were randomized to N+I (I/P risk: 425; favorable [F] risk: 125) and S (I/P risk: 422; F risk: 124). HRQoL assessment completion rates were >78% in the first 145 wks. In the total and I/P-risk populations, N+I pts report improved FKSI-19 total scores over time to wk 145 while decrease is observed with S. At 145 wks (Table), the difference in change from BL between arms for FKSI-19 total, disease-related symptoms-physical and treatment side effects scores significantly benefited N+I vs S. TTD was statistically significantly longer with N+I for most domains in both populations. Similar results were observed for FACT-G and EQ-5D change from BL and TTD.


N+I significantly improved OS vs S without worsening HRQoL. N+I sustained long-term good HRQoL and significantly delayed TTD in both the total and I/P-risk populations.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Bristol-Myers Squibb.


Bristol-Myers Squibb.


D. Cella: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Bayer; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Novartis; Advisory / Consultancy: AVEO; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Merck. B. Escudier: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Bayer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Roche. C. Ivanescu: Advisory / Consultancy: Bristol-Myers Squibb; Full / Part-time employment: IQVIA. M. Mauer: Full / Part-time employment: Bristol-Myer Squibb. J. Lord-Bessen: Full / Part-time employment: Bristol-Myers Squibb. K. Gooden: Full / Part-time employment: Bristol-Myers Squibb.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings