Significant overlap exists between questions listed in the Item Library of the European Organisation for Research and Treatment of Cancer (EORTC) and the Common Terminology Criteria for Adverse Events (CTCAE) for clinical trials, according to a new study published in the Journal of Clinical Oncology.

The EORTC is a non-profit organisation researching cancer. Its Item Library is a database containing 950 individual questions (items) from 67 questionnaires created by the EORTC to assess the impact of various side effects (also called adverse events) of treatment on the quality of life of patients with cancer.

The CTCAE is a database containing a list of over 835 different side effects, including the results of laboratory and imaging tests. Medical staff use it during cancer therapy clinical trials to classify side effects, determine their severity and report them. This is important because the number of side effects and their impact on the quality of life of a patient should be considered during such trials.

Researchers working on this study wanted to create a standardised framework to classify and improve how items are both searched for and selected from the Item Library. They did this by linking individual items from the EORTC Item Library to corresponding side effects in the CTCAE database.

The study team discovered that the EORTC Item Library holds questions associated with many common side effects in the CTCAE database. They found that out of the 950 EORTC questions, 625 were linked to 208 different side effects. Their findings suggest that future research could aim to map side effects from the CTCAE onto questions listed in the EORTC Item Library to ensure that it covers all symptomatic side effects.

This could benefit patients, medical staff, researchers and regulatory authorities by providing them with the tools to measure side effects more effectively, especially given the fast-changing clinical landscape and the 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.

Prof Jane Blazeby, a past chair of the EORTC Quality of Life Group, co-author of the study and lead of the Surgical Innovation theme at the Biomedical Research Centre based at the University of Bristol, said:

“This study brings two worlds together – very important steps for future clinical trials.”

Paper

Linking the European Organisation for Research and Treatment of Cancer Item Library to the Common Terminology Criteria for Adverse Events

Alexandra Gilbert, Claire Piccinin, Galina Velikova, Mogens Groenvold, Dagmara Kuliś, Jane M. Blazeby, and Andrew Bottomley