Cited by 44Artificial Intelligence in Healthcare and EducationElectronic Health Records SystemsEthics and Social Impacts of AI

ESMO guidance on the use of Large Language Models in Clinical Practice (ELCAP)

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Wong, E.Y.T., Verlingue, L., Aldea, M., Franzoi, M.A., Umeton, R., Halabi, S., Harbeck, N., Indini, A. +13 more·2025·Annals of Oncology

Abstract

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.

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Crossref · 10.1016/j.annonc.2025.09.001

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  • AI tools may assist with cross-referencing increasingly complex oncology guidelines, particularly when multiple variables must be considered simultaneously.

    “AI tools may assist with cross-referencing increasingly complex oncology guidelines, particularly when multiple variables must be considered simultaneously.11”

    From Artificial Intelligence in Oncology: Practical Applications Across Clinical Care, Scholarship, and Translation. (2026) · cites this paper as [11]

    In “Examples of ELCAP type 2 AI systems” (page not available), the paper says LLMs have shown promise in pointing clinicians to the correct guidelines; “Drafting documents” also describes tools that help identify relevant guidelines. It does not specifically say they cross-reference guidelines when multiple variables must be considered simultaneously, so that qualification is not established by our copy. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • The swift integration of LLMs into clinical workflows has led to the release of first official guidelines for their use in practice.

    “The swift integration of LLMs into clinical workflows has also led to the release of first official guidelines for their use in practice [11].”

    From Diagnostic performance of Prof. Valmed, ChatGPT-5 Thinking, and OpenEvidence in rheumatology: A comparative evaluation (2026) · cites this paper as [11]

    The Introduction (page unavailable) describes rapid LLM uptake and says ESMO developed guidance for their use in oncology; the practical-guidance section provides recommendations for clinicians. The paper does not establish that these were the first official guidelines, and its guidance is specific to oncology rather than clinical practice generally. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • LLMs may facilitate equitable access to information across linguistically diverse populations.

    “They may also facilitate equitable access to information across linguistically diverse populations and support patient-facing education frameworks such as European Society for Medical Oncology Guidance on the Use of Large Language Models in Clinical Practice guidance.11”

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Research works printed but not linked: 3

  1. Hao Y, Holmes JM, Hobson J, et al. Retrospective comparative analysis of prostate cancer in-basket messages: responses from closed-domain large language models versus clinical teams. Mayo Clin Proc Digit Health. 2025;3(1):100198.
  2. Arasteh ST, Lotfinia M, Bressem K, et al. RadioRAG: factual large language models for enhanced diagnostics in radiology using dynamic retrieval augmented generation. arXiv [cs.CL]. 2024. https://doi.org/ 10.48550/arXiv.2407.15621. · DOI
  3. Vedadi E, Barrett D, Harris N, et al. Towards physician-centered oversight of conversational diagnostic AI. arXiv [cs.AI]. 2025. https://doi.org/10.48550/arXiv.2507.15743. · DOI

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Authors
Wong, E. Y. T., Verlingue, L., Aldea, M., Franzoi, M. A., Umeton, R., Halabi, S., Harbeck, N., Indini, A., Prelaj, A., Romano, E., Smyth, E., Tan, I. B., Valachis, A., Vibert, J., Wiest, I. C., Yang, Y. H., Gilbert, S., Kapetanakis, G., Pentheroudakis, G., Koopman, M., & Kather, J. N.
Affiliations
  • National Cancer Centre Singapore (SG)
  • Centre Léon Bérard (FR)
  • Université Paris-Saclay (FR)
  • Inserm (FR)
  • St. Jude Children's Research Hospital (US)
  • Duke University (US)
  • LMU Klinikum (DE)
  • Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
  • University of Oxford (GB)
  • Örebro University (SE)
  • Heidelberg University (DE)
  • National Health Research Institutes (TW)
  • University Hospital Carl Gustav Carus (DE)
  • European Society for Medical Oncology (CH)
  • Utrecht University (NL)
Corresponding author
Kather, J.N.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2025-12
Volume
36
Issue
12
Pages
1447-1457
ISSN
0923-7534 (ISSN-L)
OpenAlex
W4415321775
Cited by
44
References
62
Citations by year
2026: 42 · 2025: 2
FWCI
10.59
Type
journal article
Language
en
Open access
Locations
  • Annals of Oncology (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • HAL (submittedVersion, cc-by)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
Funders
European Society for Medical Oncology
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
  • Social Sciences › Safety Research › Ethics and Social Impacts of AI
Keywords
large language models, clinical guidelines, institutional systems, patient education, symptom management, clinical workflow, data privacy, algorithmic bias, regulatory compliance, human oversight, clinical decision support
MeSH terms
Large Language Models, Europe, Humans, Language, Medical Oncology, Neoplasms, Societies, Medical

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