We have already seen in RAMPART that durvalumab and tremelimumab has a disease free survival advantage but obviously any treatment we need to evaluate for the impact of quality of life as well. So RAMPART was designed to have an optional quality of life sub-study within it so that we could look at the patient experience alongside the efficacy and DFS results.

How were patient-reported outcomes collected and assessed in the trial?

We collected the EORTC QLQ-C30 questionnaire at baseline, at week 16 and at month 15. Just so you know, the treatment in RAMPART was one year, so that was after completion of treatment. Within the analysis we looked at lots of different areas. So we looked at overall health and quality of life, five different functional domains, and at nine symptom and single item subscales as well.

What were the results?

What we saw was that at the earlier time point of week 16 there was a worsening in lots of different domains but the ones that met statistical significance and were clinically meaningful were overall health and quality of life, fatigue, insomnia and role functioning. Then when we looked at those results later, at month 15, a lot of those had improved but we did see later emerging effects in pain and self-reported cognitive function.

How should these patient-reported outcomes inform clinical practice for resected RCC?

Firstly just to say that durvalumab and tremelimumab is not currently approved but when we’re evaluating the impact of the therapy it’s important that we consider these results alongside the disease free survival advantage that we’ve already seen. If the treatment were to be approved then it’s important that we communicate these kinds of impacts on quality of life with patients and in terms of clinical care that we make sure that we’re monitoring patients at that early stage in treatment when we’re seeing those impacts and then we’re also considering late effects as well.

Is there anything else you would like to add?

Just to add that in RAMPART there was another comparison. So there’s a comparison of active monitoring and single agent durvalumab monotherapy. We will be expecting results from that later this year with patient-reported outcomes as well. So it will be interesting to see the results that we’re presenting here in comparison to the results of that comparison as well.