OBJECTIVES: Renal cell carcinoma (RCC) is the most common kidney cancer, with approximately 20 to 25% of cases of advanced disease. Understanding patient-reported outcomes (PROs) is crucial for optimizing the well-being of RCC patients. This study assessed the PRO evidence among advanced/metastatic RCC patients receiving first-line systemic therapy.

METHODS: EMBASE^® and MEDLINE^® were searched for English language articles published from database inception to May 2023 for randomized controlled trials (RCTs) evaluating PROs in advanced/ metastatic RCC. The risk of bias assessment was performed using Cochrane’s RoB-2 tool for RCTs.

RESULTS: A total of 14, phase III RCTs were included (Global=13, USA=1). Three general (EORTC-QLQ C30, EQ-VAS, EQ-5D index) and one disease-specific (FKSI) instrument were utilized to evaluate PROs in RCC patients. The treatment evaluated across the evidence included: nivolumab + cabozantinib, nivolumab + ipilimumab, lenvatinib + pembrolizumab, atezolizumab + bevacizumab, pembrolizumab + axitinib, temsirolimus + bevacizumab, sunitinib, pazopanib, sorafenib, axitinib, temsirolimus and interferon alfa.

Compared to sunitinib, nivolumab + cabozantinib, nivolumab + ipilimumab, atezolizumab + bevacizumab and pazopanib suggested favourable outcomes on FKSI total scores (p<0.05). Similar findings were reported on FKSI-DRS and FKSI-FWB domains except for pazopanib. In terms of general instruments, lenvatinib + pembrolizumab group exhibited significant improvement over sunitinib on EORTC QLQ-C30 physical functioning and symptom domains including fatigue, dyspnoea, and constipation (p<0.05); the results were in favour of sunitinib when compared to lenvatinib + everolimus for symptom domains including pain, diarrhoea, and appetite loss (p<0.05). Further, the analysis of EQ-5D-3L VAS and utility index scores demonstrated favourable outcomes with nivolumab + cabozantinib and nivolumab + ipilimumab compared to sunitinib. However, statistical significance was observed only with nivolumab + cabozantinib.

CONCLUSIONS: Immunotherapy combinations, including targeted therapy, resulted in improved PROs in RCC. Further research is needed to validate and assess the impact of additional treatments on PRO.