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
|Domain||LS 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]|
|All||Intermediate / Poor risk||All||Intermediate / Poor risk|
|Total||2.99 [0.92; 5.06]a||4.24 [1.38; 7.09]a||0.54 [0.47; 0.63]a||0.54 [0.46; 0.63]a|
|DRS||0.83 [-0.15; 1.82]||1.18 [-0.20; 2.56]||0.64 [0.55; 0.74]a||0.66 [0.56; 0.79]a|
|DRS-Physical||1.69 [0.33; 3.05]a||2.49 [0.58; 4.40]a||0.57 [0.49; 0.67]a||0.58 [0.49; 0.69]a|
|DRS-Emotional||0.23 [-0.04; 0.49]||0.10 [-0.26; 0.46]||0.90 [0.74; 1.09]||0.90 [0.73; 1.13]|
|Treatment side effects||0.73 [0.26; 1.20]a||1.01 [0.36; 1.65]a||0.42 [0.36; 0.49]a||0.45 [0.38; 0.53]a|
|Functional well-being||0.47 [-0.23; 1.18]||0.75 [-0.22; 1.72]||0.76 [0.66; 0.88]a||0.77 [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
Legal entity responsible for the study
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.
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