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

Date 30 September 2019
Event ESMO 2019 Congress
Session Poster Display session 3
Topics Renal Cell Cancer
Presenter David Cella
Citation Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249
Authors D. Cella1, B. Escudier2, C. Ivanescu3, M. Mauer4, J. Lord-Bessen5, K. Gooden6
  • 1Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 60611 - Chicago/US
  • 2Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 3Statistics, IQVIA, 181 - Herikerbergweg/NL
  • 4Oncology Clinical Development, Bristol-Myers Squibb, 08648 - Lawrenceville/US
  • 5Health Economics Outcomes Research, Bristol-Myers Squibb, 08648 - Princeton/US
  • 6Ww Heor, Bristol-Myers Squibb, 08540 - Princeton/US

Abstract

Background

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.

Methods

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).

Results

Table:

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
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.

Conclusions

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.

Funding

Bristol-Myers Squibb.

Disclosure

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.