IO-Synthesise RCC: Analysis of real-world (RW) health-related quality of life (HRQoL) outcomes with nivolumab for previously treated metastatic renal cell carcinoma (mRCC) using pooled data from France and Germany

Nivolumab (NIVO) showed improved HRQoL versus everolimus in the phase 3, randomized CheckMate 025 trial of patients (pts) with previously treated mRCC. However, HRQoL data from RW settings are limited. Here, we report HRQoL outcomes for pts receiving NIVO for previously treated mRCC in 2 European RW studies. As a part of the IO-Synthesise RCC initiative, data for adult pts with mRCC who received second- (2L) or third-line (3L) NIVO monotherapy were pooled from the French WITNESS (NCT03455452) and German NORA (NCT02940639) prospective, noninterventional studies. HRQoL measures included the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) and EQ-5D-3L utility index (UI) and visual analog scale (VAS). All pts with a baseline HRQoL assessment were included. Data from 306 pts (France, N = 105; Germany, N = 201) were pooled. Median age was 70 years, 74.5% were male. In pts with available data, 75.5% had a Karnofsky performance score (KPS) > 70%. NIVO was given as 2L in 83.3%. Baseline characteristics were mostly consistent between French and German pts; a higher proportion of French pts with available data had a KPS ≤ 70% (37.6% vs 16.9%) and a lower proportion had prior nephrectomy (65.7% vs 86.4%). Completion rates for all individual measures/subscales were > 70% at week 6 and ∼47% at month 18. Results are summarized in the table; no significant HRQoL decrements were observed and a numerical trend for improved FKSI-19 total and disease-related symptoms (DRS) subscale scores was seen at most timepoints.Table: 1460PMean change from baseline (95% CI)Week 6Month 3Month 6Month 9Month 12Month 18FSKI-19n = 221n = 192n = 128n = 99n = 84n = 47Total0.53 (–0.76, 1.82)–0.25 (–1.83, 1.33)0.68 (–1.40, 2.77)1.62 (–0.42, 3.65)2.71a (0.38, 5.04)1.28 (–1.39, 3.95)DRS0.43 (–0.24, 1.11)–0.26 (–1.09, 0.56)–0.01 (–1.10, 1.08)0.38 (–0.65, 1.40)1.58a (0.40, 2.76)1.05 (–0.46, 2.56)EQ-5D-3LUIn = 208 0.0 (–0.03, 0.04)n = 184 –0.02 (–0.06, 0.02)n = 125 –0.05 (–0.10, 0.01)n = 94 –0.04 (–0.10, 0.01)n = 80 –0.02 (–0.09,0.06)n = 44 –0.02 (–0.11, 0.06)VASn = 192 –0.01 (–2.91, 2.89)n = 170 1.25 (–1.82, 4.32)n = 118 1.44 (–2.85, 5.73)n = 91 1.56 (–3.17, 6.28)n = 75 –3.24 (–9.31, 2.82)n = 43 –6.09 (–13.09, 0.91)aP < 0.05 vs baseline. Open table in a new tab aP < 0.05 vs baseline. Despite the challenge of suboptimal HRQoL completion rates in RW settings, pooled HRQoL data from these pts with mRCC receiving 2L or 3L NIVO in France and Germany appear to complement results from CheckMate 025 and suggest pts with previously treated mRCC maintain HRQoL after receiving NIVO.