Comprehensive quality of life assessment in advanced renal cell carcinoma: Final results of the PRO Kidney study.

INTRODUCTION: Patient-reported outcomes (PROs), particularly health-related quality of life (HRQoL) and treatment-related side effects, are crucial for guiding treatment in advanced renal cell carcinoma (aRCC). We report longitudinal PRO data prospectively collected in a real-world aRCC setting during the targeted therapy era. METHODS: Patients with aRCC were enrolled in the prospective, observational, multicenter PRO Kidney cohort study (NCT02537743) from 2015-2018. PROs were assessed tablet-based from baseline up to 24 months using validated instruments (NCCN FACT FKSI 19, FACIT Fatigue), and custom questions on RCC-/treatment-specific symptoms (IOAE) and daily life impact (IODAYA). Descriptive statistics were used, except for time-to-deterioration (TTD) analysis. RESULTS: Of 98 patients signing informed consent, 90 with at least one completed PRO questionnaire were included in the full analysis set; 80 with baseline questionnaires were analyzed for HRQoL. Median age was 68 years; 78.9% (n=71) presented with clear-cell histology and 44.4% (n=40) were at intermediate MSKCC risk. The most frequently used first-line treatments were pazopanib (56.7%; n=51) and sunitinib (23.3%; n=21). Clinically relevant deterioration in HRQoL was observed in 52.5% (n=42) of patients within six months (median TTD 5.1 months, 95%CI 2.9-7.0). Treatment was associated with fatigue, nausea, diarrhea and altered taste, independent of treatment regimen. Most patients reported being content with their HRQoL and were able to continue with their day-to-day activities. DISCUSSION: Despite treatment-related side effects and HRQoL deterioration in some patients, most maintained daily functioning and reported acceptable overall HRQoL, suggesting that tyrosine kinase inhibitor monotherapy may remain a valuable option, particularly for those with contraindications to immunotherapy.