PRO-CTCAE and earlier toxicity detection in phase I clinical trials

Authors & Affiliations

K. Ouali (1), A. Yazigi (2) , S. Jetley (2), A. Hollebecque (1), Y. Loriot (1), M. Sakkal (1), A. Gazzah (1), J.-M. Michot (1), R.Bahleda (1), T. Hueso (1), K. Amrane (1), A. Patrikidou (1), S. Postel-Vinay1, F.-X. Danlos (1), V. Ribrag (1), A. Marabelle (1), A. Italiano (1), J. Ribeiro (1), C. Ferté (2), C. Massard (1)

1 — Drug Development Department, Institut Gustave Roussy, Villejuif, France,
2 — Resilience Care, Resilience, Paris, France

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Phase I clinical trials still rely heavily on clinical assessment of acute toxicities to guide dose decisions. Presented at ESMO 2026, this study explores how frequent PRO-CTCAE monitoring through remote patient monitoring could complement this assessment by capturing patient-reported symptoms earlier and providing a more detailed picture of treatment tolerability.