ESTRO 2024 - Abstract Book

S2679

Interdisciplinary - Education in radiation therapy

ESTRO 2024

Brunswick, N., Wardle, J., & Jarvis, M. J. (2001). Public awareness of warning signs for cancer in Britain. Cancer Causes & Control, 12, 33-37.

1388

Mini-Oral

Mind the gap, BRIDGE the gap: assessing, reporting and comparing morbidity in clinical trials

Sofia Spampinato 1 , Kari Tanderup 1,2 , Amelia Barcellini 3,4 , Ewa Burchardt 5 , Gemma Eminowicz 6 , Barbara Šegedin 7 , Magdalena Stankiewicz 8 , Margit Valgma 9 , Kathrin Kirchheiner 10 1 Aarhus University Hospital, Danish Centre for Particle Therapy, Aarhus, Denmark. 2 Aarhus University, Department of Clinical Medicine, Aarhus, Denmark. 3 National Center for Oncological Hadrontherapy (CNAO), Radiation Oncology Unit, Clinical Department, Pavia, Italy. 4 University of Pavia, Department of Internal Medicine and Medical Therapy, Pavia, Italy. 5 Department of Radiotherapy, Greater Poland Cancer Center in Poznan and University of Medical Sciences, Poznan, Poland. 6 University College London Hospital, Department of Oncology, London, United Kingdom. 7 Institute of Oncology, Department of Radiotherapy, Ljubljana, Slovenia. 8 Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Brachytherapy Department, Gliwice, Poland. 9 North Estonia Medical Centre Foundation, Radiotherapy Centre, Tallinn, Estonia. 10 Medical University of Vienna, Department of Radiation Oncology, Comprehensive Cancer Center, Vienna, Austria To evaluate changes in definitions and severity grades and the impact on scoring for gynaecological radiotherapy (Gyn-RT) using different versions of the Common Terminology Criteria for Adverse Events (CTCAE), the established tool to report morbidity in clinical trials. Provided by the National Cancer Institute (NCI), CTCAE offers a standardized classification of adverse events (AEs) in cancer therapy. The first version focusing on late AEs was CTCAEv.3 (2006). CTCAEv.4 (2009) mapped AEs to terms of the Medical Dictionary for Regulatory Activities System Organ Class (SOC) (1). Furthermore, the impact on instrumental and self-care activities of daily life (ADL) was introduced in severity grade definitions. CTCAEv.5 (2017) included additional AEs and corrections to CTCAEv.4. In addition to shifting from category systems to SOC and the increasing number of AEs, definitions of terms and severity changed between versions. This analysis presents the pilot results of the BRIDGE project (Better Reporting, Instructions and Dissemination to Generate Evidence from clinical trials), aimed at raising awareness on the importance of accurate morbidity scoring in radiotherapy. Purpose/Objective:

Material/Methods:

The CTCAE system is organized in severity grades: G1=mild; G2=moderate; G3=severe; G4=life-threatening; G5=death due to AE. This analysis used mapping tables provided by NCI to convert AEs terms and grades between CTCAE versions (2). AEs relevant to Gyn-RT were selected. A first objective evaluation verified whether changes in severity grades were present in new versions compared to CTCAEv.3. Afterwards, six radiation oncologists (ROs) with experience in Gyn-RT from five European countries evaluated changes in definitions based on their clinical judgement. A multiple-choice evaluation form was created by modifying the mapping tables and addressing these aspects using CTCAEv.3 severity grade definitions as reference:

• Severity: changes in definition that may impact the interpretation.