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EORTC Item Library provides considerable coverage of CTCAE side effects, new study finds

Clinicians, researchers and regulatory authorities point to the increasing need to integrate a patient-centred approach to measure side effects (also called adverse events, AEs) given the fast-changing clinical landscape and increasing use of novel therapies. While cancer research primarily aims to increase survival, it is important to also consider the burden of side effects and the impact on patients’ quality of life (QOL).

A new study by Gilbert A., Piccinin C. et al.1, published this month in Journal of Clinical Oncology, was conducted with the aim to create a standardised framework to systematically classify, and improve searchability and item selection for relevant AEs from the EORTC Item Library. This framework will be integrated into the Item Library online searchable database.

CTCAE, PROs and the Item Library

The gold standard for the classification of side effects reporting in cancer clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE). Used by clinicians, it includes over 835 different side effects, including laboratory and imaging findings.

Patient-reported outcomes (PROs) complement clinician reporting by directly capturing the patient perspective. The EORTC Item Library supplements the standard PRO questionnaires and modules developed by the Quality of Life Group (QLG) of the European Organisation for Research and Treatment of Cancer (EORTC) to assess quality of life of cancer patients. The Item Library allows for more flexibility through customised lists of questions (item lists) that can be used to better cover new disease and treatment contexts. It covers symptoms and treatment-related burden but also functioning (e.g., emotional) and overall QOL.

About the study

This new study by Gilbert A., Piccinin C. et al. assessed the coverage of AEs within the EORTC Item Library, on the basis of the CTCAE. To do so, the authors looked at the CTCAE and linked EORTC Item Library items (questions) to corresponding side effects. Interestingly, they found that out of the 950 EORTC questions, 625 (65.8%) were linked to 208 different side effects.

This is the first comprehensive analysis and mapping to have looked for corresponding CTCAE AEs within the Item Library. Based on the findings, the study shows that the EORTC Item Library provides good coverage of many common side effects.

As Dr Alexandra Gilbert, EORTC QLG member based at the University of Leeds, United Kingdom, co-author, highlights: “the EORTC Item Library provides considerable coverage of side effects important to cancer patients, along with many other complementary issues, such as impact on emotional wellbeing”. Claire Piccinin, from the EORTC, Belgium, and co-author, adds: “This framework provides researchers and clinicians with details on which questions are most relevant for specific side effects. This will optimise their use in clinical trials and routine care”.

The authors suggest future work may look at mapping symptomatic AEs from the CTCAE to the EORTC Item Library, to ensure that the EORTC Item Library has comprehensive coverage of all symptomatic side effects.

About the Quality of life Group

The Quality of Life Group (QLG) strives to improve health-related quality of life (HRQoL) of cancer patients, through dedicated research and the use of HRQoL measures within cancer clinical trials and clinical practice. HRQoL constitutes an important aspect of cancer research and care: it gives a voice to patients, putting their experience at the forefront. The QLG is part of the European Organisation for Research and Treatment of Cancer (EORTC).

About EORTC

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.
For further information, please visit the EORTC website: www.eortc.org

About the University of Leeds

The University of Leeds is one of the largest higher education institutions in the UK, with more than 39,000 students from more than 137 different countries. We are renowned globally for the quality of our teaching and research.
We are a values-driven university, and we harness our expertise in research and education to help shape a better future for humanity, working through collaboration to tackle inequalities, achieve societal impact and drive change.
The University is a member of the Russell Group of research-intensive universities, and is a major partner in the Alan Turing, Rosalind Franklin and Royce Institutes www.leeds.ac.uk
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1 Gilbert A*, Piccinin C*, Velikova G, Groenvold M, Kuliś D, Blazeby JM, Bottomley A. Linking the European Organisation for Research and Treatment of Cancer Item Library to the Common Terminology Criteria for Adverse Events. J Clin Oncol. 2022 Aug 16:JCO2102017. doi: 10.1200/JCO.21.02017. Epub ahead of print. PMID: 35973158.

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