Abstract / Summary
RAMPART is an international phase III trial evaluating adjuvant immune checkpoint inhibitors (ICIs) after nephrectomy for renal cell carcinoma. ICIs have a distinct toxicity profile that can significantly impact health-related quality of life (HRQoL); however existing HRQoL questionnaires were developed in a pre-ICI era and may not fully capture the patient experience. To address this, we embedded a qualitative interview sub-study within RAMPART among UK participants to explore the impact of ICIs on HRQoL in depth. Eligible participants were enrolled in RAMPART at UK sites and randomised to Arm B (durvalumab q4w for 1 year) or C (durvalumab q4w for 1 year plus tremelimumab at day 1 and week 4). Participants were purposively selected to ensure representation across baseline characteristics, treatment tolerance, toxicity development, and recurrence status. Interviews were conducted online, via telephone and in person, with transcripts analysed using the framework method. Of 220 eligible participants, 71 were invited; with recruitment closing early due to a high response rate. 37 expressed interest, and 23 were interviewed. Two themes were generated based on participant insights: Living in a Changed Body and Mind and It Depends on Your Life: How Context Shapes the Impact of Immune Related Adverse Events (irAEs). The findings suggest that participants often placed greater importance on the duration and chronicity of irAEs than their severity when describing impacts on HRQoL. Persistent toxicities, including fatigue, arthralgia, and diarrhoea, disrupted daily functioning, while cognitive changes and emotional strain were common. Employment, financial security, and caregiving responsibilities influenced the impact of irAEs, whereas supportive relationships and structured follow-up mitigated their burden. Chronic irAEs can negatively affect HRQoL, mental health, and the ability to work. Clinical trials evaluating ICIs should report toxicity grade, duration, and resolution to better inform patient decision-making. Development of ICI-specific HRQoL tools that capture the impact of persistent irAEs is needed, alongside clear care pathways for management of chronic irAEs.