Patient-reported outcomes in resected renal cell carcinoma: Active monitoring vs. durvalumab and tremelimumab in the RAMPART trial.

Abstract

420 Background: Durvalumab + Tremelimumab (DT) given over one year (with Tremelimumab at Day 1 and Week 4), improved disease-free survival in patients with resected renal cell carcinoma at intermediate/high risk of relapse in the RAMPART trial. Evaluating quality of life (QoL) is key to understanding the overall impact of treatment. The primary QoL outcome in RAMPART was the change in overall health and quality of life (OHQL) from baseline to 15 months, and no difference was observed between participants assigned DT versus active monitoring (AM). We now present detailed QoL outcomes from the comparison of DT versus AM. Methods: This analysis includes participants randomly assigned (3:2) to AM or DT, who participated in the optional QoL sub study and completed the EORTC QLQ-C30 at baseline plus ≥1 follow-up (Week 16 or Month 15). Outcomes assessed include OHQL (Q29–30) at Week 16, five functional domains, eight symptom domains, and financial difficulties at both Week 16 and Month 15. Clinically meaningful differences (CMD) were predefined by item and scale. Results: A total of 254 participants were included (150 AM, 104 DT). Baseline characteristics were similar, with minor differences in sex distribution (male: 68% AM vs 74% DT) and performance status (PS 0: 80% AM vs 88% DT; PS 1: 20% AM vs 12% DT). At week 16, scores were worse in those assigned DT rather than AM for OHQL (–8.1; 95% CI: –12.8 to –3.4; p = 0.0008), role function (–6.0; 95% CI: –11.9 to –0.2; p = 0.04), fatigue (8.4; 95% CI: 3.2 to 13.7; p = 0.002), and insomnia (8.9; 95% CI: 1.3 to 16.4; p = 0.02). All exceeded the minimum threshold for a small CMD (CMD: OHQL 4–<10, role function 6–<19, fatigue 5–<13, insomnia 4–<13). At month 15, scores were worse in those assigned DT rather than AM for pain (8.8; 95% CI: 1.4 to 16.2; p = 0.02) and cognitive function (–5.8; 95% CI: –11.5 to –0.2; p = 0.04), both exceeding the predefined thresholds for a small CMD (CMD: pain 6–<13, cognitive function 3–<9). No other domains, symptom scales, or single items met both statistical and clinical thresholds at either timepoint. Conclusions: DT was associated with worse QoL at week 16 than AM, particularly in OHQL, role function, fatigue and sleep, all reaching clinically meaningful thresholds. These effects appeared to improve by month 15. At month 15, pain and cognitive function were worse in the DT arm. These findings should be considered alongside the DFS benefit when discussing treatment options with patients. Clinical trial information: NCT03288532 .