ASCO 2026 | Decision regret & toxicity perception following adjuvant IO in kidney cancer
Elizabeth Nally, MBBS, Barts Cancer Institute, London, UK, discusses the discrepancy between clinical trial results and real-world patient experiences regarding toxicity and quality of life in patients with kidney cancer treated with adjuvant immunotherapy. A novel patient-informed toxicity categorization system revealed a significant discrepancy between traditional Common Terminology Criteria for Adverse Events (CTCAE) grading and patient-defined toxicity, with over 30% of mild events being recategorized as significant or life-changing. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
There have been multiple adjuvant trials in renal cell carcinoma. And one of the things that we found really interesting is that despite the trial showing different rates of toxicity between the treatment and the placebo arm, the quality of life analysis tends to show no difference between the arms. And I think from our clinical practice, it doesn’t quite resonate with what we see in our clinics in that there are some of these patients with immunotherapy that can have lifelong toxicity...
There have been multiple adjuvant trials in renal cell carcinoma. And one of the things that we found really interesting is that despite the trial showing different rates of toxicity between the treatment and the placebo arm, the quality of life analysis tends to show no difference between the arms. And I think from our clinical practice, it doesn’t quite resonate with what we see in our clinics in that there are some of these patients with immunotherapy that can have lifelong toxicity. And we wondered whether the tools that we’re using to measure toxicity or the way we’re carrying out a quality of life analysis may not be reflecting the true patient experience. So we worked very closely with patients to come up with a new toxicity categorization, which patients felt better reflected their experiences of adjuvant immunotherapy. And there were these four groups, life-changing, significant long-term, significant short-term, and non-significant. And what we did is we fortunately had access to a large randomized Phase III trial, which was the IMmotion010 study. And we looked at all the toxicity data collected in that trial and recategorized it according to this novel patient-informed criteria. There’s a fair bit of discrepancy between CTCAE grading and the patient-defined toxicity. So typically grade one to two events we think of being quite mild. Over 30% of those were recategorized as significant or life-changing, highlighting that discrepancy. And what we did then is we applied this toxicity framework and looked at its association with quality of life from the data in the IMmotion010 study. I said earlier, this is a randomized global phase three trial. And the conventional analysis, as all the previous trials have shown, there was no difference between the two arms. But when we applied the novel framework, we saw a really interesting signal with the patients that had life-changing toxicity. They had a detriment in quality of life from the discontinuation point, and that quality of life stayed down and low all the way up until four years, really highlighting the impact of these long-term toxicities on patients in the curative setting.
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