Attitudes to adjuvant therapy in patients with renal cancer
Research type
Research Study
Full title
Attitudes to therapy and decision making in patients with renal cell carcinoma (RCC) offered adjuvant immune checkpoint inhibitor (ICI)
IRAS ID
356943
Contact name
Tom Powles
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
KEYNOTE-564 is the first phase III trial to show improved overall survival (OS) with adjuvant ICI. In patients with resected RCC who received one year of adjuvant pembrolizumab there was decreased risk of death by 38% versus placebo. This practice changing study has led to adjuvant pembrolizumab being approved by FDA and NICE for patients with intermediate and high risk RCC who are free of disease after surgical resection.
With adjuvant pembrolizumab becoming standard of care for intermediate and high risk RCC new questions have emerged. Adjuvant ICI is associated with frequent immune-related adverse events (irAEs). Some of these irAEs are serious and can affect patients after completing therapy such as endocrine toxicities which are mostly irreversible and lifelong. KEYNOTE-564 found nearly 20% of patients who received pembrolizumab sustained a grade 3-4 toxicity.
Patient attitudes and survivorship outcomes with adjuvant ICI particularly in RCC have not been established. Since the majority of patients would not have relapsed following surgery, discussions regarding risk and benefit are vital particularly when immunotherapy toxicity can be lifelong. Assessing how patients view their decision to opt for adjuvant therapy throughout their cancer treatment journey will be increasingly important particularly with increased indication and earlier use of ICI across cancer types.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
25/WM/0152
Date of REC Opinion
14 Aug 2025
REC opinion
Further Information Favourable Opinion