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ESMO 2026 | Patient-reported toxicity precedes dose-limiting toxicities in Phase I trials

Kaissa Ouali, MD, Institut Gustave Roussy, Villejuif, France, explores a prospective cohort study evaluating whether weekly remote patient-reported outcome monitoring can detect symptomatic toxicity earlier than clinician-graded assessments in Phase I oncology trials. High-grade patient-reported events typically preceded both dose-limiting toxicities and tolerability events, such as treatment interruption or dose reduction, and incorporating these data modestly improved prediction of safety outcomes. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.

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Transcript

We know from multiple studies that we tend to overestimate AEs in patients treated in phase one trials and so we decided to actually implement PROs and remote monitoring in our patients in October 2024. What we were able to see is that we actually captured grade 3 and 4 adverse events before the DLT, which is pretty important because probably by implementing PROs in phase 1, we are going to better select the dose in the future, which is what we do in phase 1...

We know from multiple studies that we tend to overestimate AEs in patients treated in phase one trials and so we decided to actually implement PROs and remote monitoring in our patients in October 2024. What we were able to see is that we actually captured grade 3 and 4 adverse events before the DLT, which is pretty important because probably by implementing PROs in phase 1, we are going to better select the dose in the future, which is what we do in phase 1.

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