Abstract PS04-04: Adverse effects (AEs) reported via Patient Reported Outcome Measures (PROMs): A longitudinal analysis of the IMPORT HIGH breast radiotherapy trial (CRUK/06/003)
Authors: Ng Sze Yi , Bhattacharya Indrani , Haviland Joanne , Griffin Clare , Sydenham Mark , Kirby Anna , Hopwood Penelope , Kirwan Cliona , Coles Charlotte , Bliss Judith 
Published: May 2024

Abstract
Background
IMPORT HIGH is a multicentre phase III randomised controlled trial showing efficacy and safety of appropriately-dosed simultaneous integrated boost (SIB) in terms of local control, patient and clinician reported AEs among women with early breast cancer (BC)[1]. The PROMs sub-study collected baseline demographics and quality of life over 5 years. This exploratory analysis details the patient experience over time.
Methods
Women with higher-than-average risk of local relapse (≥18 years, breast conserving surgery, T1-3, pN0-pN3a, M0 invasive BC) were eligible. Randomisation (1:1:1) was between 40Gy whole breast and 16Gy sequential boost radiotherapy (control) and, 36Gy whole breast, 40Gy partial breast with either 48Gy SIB (test group 1), or 53Gy SIB (test group 2) radiotherapy.
AEs from EORTC QLQ-BR23[2]; Body Image Scale (BIS)[3]; and protocol-specific (PS) items used in previous breast radiotherapy trials[4] were reported by patients at baseline (pre-randomisation), 6 months, and years 1, 3, 5. 24 AEs[4] were included in the analysis, dichotomised as none/mild versus moderate/marked. Anxiety and depression were measured over 5 years using Hospital Anxiety and Depression Scale. Surgical deficit was scored from baseline photographs.
Multivariable generalized estimating equation models were fitted for each AE. Potential baseline predictors included those used previously[4] plus ethnicity, smoking, deprivation, employment, cardiovascular disease history, post-operative infection, haematoma, post-surgery complication. Backwards selection and Quasi-likelihood criterion were used for model selection.
Results
Between 2009-2013, 1338 patients were offered the PROMs sub-study and 1078 (81%) participated. Median age was 48.8 years (IQR 44.0-54.9). 17% reported ‘Borderline’ or 14% ‘Case’ anxiety at baseline. 11% reported ‘Borderline’ or 7% ‘Case’ depression at baseline.
747/1015 (74%), 686/986 (70%), 604/916 (66%), 532/845 (63%), 461/709 (65%) of participants reported at least 1 moderate/marked AE at baseline, 6 months, 1, 3 and 5 years. Number of moderate/marked AEs reported per person reduced over time after year 1 (p &lt; 0.005). BIS reported moderate/marked AEs (except dissatisfaction with scar) decreased, whereas individual items from BR23 and PS items showed mixed patterns of reporting (increased, decreased, stayed the same) over time (Table 1).
From multivariable analysis, ‘Borderline’ or ‘Case’ depression or anxiety (time-varying) was associated with increased reports for almost all AEs. Chemotherapy and younger age were associated with increased reports of moderate/marked AEs for items in BIS, and large surgical deficit predicted more breast symptoms.
Conclusion
Change of overall breast appearance was the most reported moderate/marked AE that persisted over time.Although patients reported fewer moderate/marked AEs over time, trends in individual moderate/marked AEs showed mixed patterns. This study identified factors associated with increased risks of patient-reported moderate/marked AEs. Early identification of patients more likely to report AEs could facilitate implementation of targeted support.
References
1. Coles et al, The Lancet 2023
2. Sprangers et al, J Clin Oncol 1996
3. Hopwood et al, Eur J Cancer 2001
4. Bhattacharya et al, J Clin Oncol 2019
Table 1 Trend over time for most commonly reported AE from each questionnaire
Citation Format: Sze Yi Ng, Indrani Bhattacharya, Joanne Haviland, Clare Griffin, Mark Sydenham, Anna Kirby, Penelope Hopwood, Cliona Kirwan, Charlotte Coles, Judith Bliss. Adverse effects (AEs) reported via Patient Reported Outcome Measures (PROMs): A longitudinal analysis of the IMPORT HIGH breast radiotherapy trial (CRUK/06/003) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS04-04.