ESMO guidance on the use of Large Language Models in Clinical Practice (ELCAP)Office of Data Science, St. Jude Children's Research Hospital, Memphis, USA; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, USA; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, USA.
Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, USA.
Breast Center, Department of OB&GYN and CCC Munich, LMU University Hospital, Munich, Germany.
Department of Medical Oncology and Hematology, Fondazione IRCCS-Istituto Nazionale dei Tumori, Milan, Italy.
AI-ON-Lab, Department of Medical Oncology and Hematology, Fondazione IRCCS-Istituto Nazionale dei Tumori, Milan, Italy.
Department of Medical Oncology, Inserm U932, Institut Curie, Paris, France.
Oxford NIHR Biomedical Research Centre, Oxford, UK.
Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Paris-Saclay University, Paris, France; Drug Development Department, Gustave Roussy, Villejuif, France.
Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
ELLOK-Hellenic Cancer Federation, Athens, Greece.
ESMO-European Society for Medical Oncology, Lugano, Switzerland.
Department of Medical Oncology, UMC-University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; Department of Medicine I, University Hospital Dresden, Dresden; Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
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2025 (English)In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 36, no 12, p. 1447-1457Article in journal (Refereed) Published
Abstract [en]
BACKGROUND: Large language models (LLMs) are rapidly being integrated into health care, with substantial implications for oncology practice. The European Society for Medical Oncology (ESMO) developed the ESMO guidance on the use of Large Language Models in Clinical Practice (ELCAP) to provide a structured framework and basic guidance for their safe and effective application in oncology.
PATIENTS AND METHODS: Between November 2024 and February 2025, a multidisciplinary group of 20 experts convened under the ESMO Real World Data and Digital Health Task Force. Using literature review and a Delphi consensus process, the panel defined three categories of LLM use in oncology: type 1 (patient-facing applications), type 2 [health care professional (HCP)-facing applications], and type 3 (background institutional systems). Consensus statements were developed for each type to provide basic practical guidance.
RESULTS: ELCAP highlights opportunities such as improved patient education and symptom management, streamlined clinical workflows, and enhanced data processing. At the same time, it addresses challenges including data privacy, algorithmic bias, regulatory compliance, and the risk of unsupervised use. The framework emphasises human oversight, protection of patient privacy, and alignment with clinical and ethical standards. Patient-facing tools should complement, not replace, professional advice and should be embedded in supervised care pathways. HCP-facing and background systems may improve efficiency and decision support but require systematic validation, transparency, and continuous monitoring.
CONCLUSIONS: ELCAP provides a three-tier framework and basic practical guidance for LLM use in oncology. ESMO supports efforts to use this framework to improve patient care, but warns against unsupervised or unvalidated use.
Place, publisher, year, edition, pages
Elsevier, 2025. Vol. 36, no 12, p. 1447-1457
Keywords [en]
AI, clinical decision making, large language model
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:oru:diva-124479DOI: 10.1016/j.annonc.2025.09.001ISI: 001634474900001PubMedID: 41111032Scopus ID: 2-s2.0-105024015290OAI: oai:DiVA.org:oru-124479DiVA, id: diva2:2007407
2025-10-202025-10-202026-01-23Bibliographically approved