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

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 receiveN3 mg/kg+ I 1mg/kg every3wk for 4doses thenN3mg/kg every 2 wk, or S 50mg/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 ofwk 1 of subsequent cycles. An exploratoryHRQoL analysis was conducted using the Functional Assessment of Cancer Therapy-Kidney SymptomIndex (FKSI-19), Functional Assessment of Cancer Therapy-General (FACT-G) and EQ-5D instruments. The analyses included mixed-model repeatedmeasures (MMRM) for change from baseline (BL) at 145 wks (while on-treatment), and time to deterioration (TTD). Results: 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-termgood HRQoL and significantly delayed TTD in both the total and I/P-risk populations. (Table Presented).