ESTRO 2024 - Abstract Book

S2680

Interdisciplinary - Education in radiation therapy

ESTRO 2024

• Subjectivity: definition based on patient's reporting or ADL. • Clinical information: quantitative clinical information (e.g. medications/interventions). • Severe AEs: expected rate of G≥3.

For each RO, the percentages of major changes in severity, subjectivity, clinical information and severe AEs rate were calculated using the valid numbers of responses. The median value of the percentages for each RO was then calculated. The highest and lowest percentages for ROs were removed to avoid extreme outliers, if present. If percentages were 0% for ≥3 ROs, the overall median was also considered 0%.

Results:

The analysis included 125 AEs. Figure1.a shows the overlap between CTCAEv.4 SOC and CTCAEv.3 Categories. Results of the first investigation are reported in Figure1.b. The most frequent change compared to CTCAEv.3 was absence of G4 (n=26), merged to G3 in new versions. Other changes in grade were also present (n=6), and G1 and G5 were sometimes not defined (n=13 and n=9, respectively). Furthermore, some individual AEs in CTCAEv.3 were grouped into a single AE in new versions (i.e. “vaginal mucositis” and “vaginitis” are under “vaginal inflammation”). Overall, a change was recorded for 53 severity grades. The results of ROs evaluations are reported in Figure2. The bar charts represent the median of percentages for each RO on changes in severity definition and subjectivity, and quantitative clinical information compared to CTCAEv.3. For Gastrointestinal AEs, G2 underwent more changes in definition (>20%) and contained less quantitative information (>50%). Both Renal/Urinary and Injury/Musculoskeletal AEs had changes in severity definitions for G2-G3 (15-20%), but they were also based on more quantitative information (20-25%). General AEs had more changes in severity definition for G4 (20%), also being less quantitative (20%). Grade definitions for Reproductive AEs were also based on less quantitative information (15-30%). Considering all AEs, G2-G3 were affected by more changes in severity definitions (>15%), G2 being also more subjective (20%). Overall, grades were also based on less quantitative information (>20%), except for G1 that was often containing more (30%). For Severe AEs rates, in median it was expected to record less and more G≥3 using the new versions in 19% and 39% of AEs, respectively. However, considerable variability was recorded in ROs evaluations, ranging from 17% to 50% for expected more G≥3. Variations in assessments were present also in the other aspects, but to a lesser extent.