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Five-year trends and baseline predictors of patient-reported adverse events following breast radiotherapy with a boost in the IMPORT HIGH phase III randomised controlled trial
Ng, S. Kilburn, L. S. Kirby, A. M. Griffin, C. Sydenham, M. Kirwan, C. C. Haviland, J. S. Bhattacharya, I. S. Jefford, M. Syndikus, I.
Ng, S.
Kilburn, L. S.
Kirby, A. M.
Griffin, C.
Sydenham, M.
Kirwan, C. C.
Haviland, J. S.
Bhattacharya, I. S.
Jefford, M.
Syndikus, I.
Abstract
BACKGROUND AND PURPOSE: IMPORT HIGH demonstrated non-inferiority of simultaneous integrated boost against sequential boost for ipsilateral breast tumour relapse. Patient-reported adverse events (AEs) were similar across treatment groups. In this longitudinal analysis of patient-reported AE data from IMPORT HIGH we describe prevalence and baseline predictors of patient-reported AEs over 5-years. MATERIALS AND METHODS: IMPORT HIGH (ISRCTN47437448) recruited women with early breast cancer and higher-than-average local recurrence risk. All participants received breast radiotherapy and a boost. Patient-reported outcomes (PROs) were recorded using EORTC QLQ-C30, QLQ-BR23, Body Image Scale administered at baseline, 6 months, 1, 3, 5-years. AEs were recorded on a 4-point-scale and dichotomised (none/mild versus moderate/marked) for analysis. Generalised Estimating Equations assessed patterns of moderate/marked AEs and their baseline predictors. RESULTS: 52/76 IMPORT HIGH centres participated in the PRO sub-study. 1078/1338 patients consented. 270/762 (35.4 %) patients reported no moderate/marked AEs at 5-years. Most common moderate/marked AEs at 5-years were overall change in breast appearance (257/762, 33.7 %) and having a smaller breast (222/762, 29.1 %). Arm and breast symptoms peaked at 6-month assessment, with breast symptoms improving but arm symptoms persisting over 5-years. Body image-related AEs improved from baseline. Younger age and anxiety were the commonest baseline predictors of AEs. CONCLUSION: This longitudinal analysis of PROs in a large trial of breast and boost radiotherapy demonstrates an overall decrease in the number of patient-reported moderate/marked AEs up to 5-years following radiotherapy. Baseline factors predicting AE development include younger age and anxiety, informing support strategies for patients receiving whole breast and boost radiotherapy.
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Date
2025
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Article
Citation
Ng S, Kilburn LS, Kirby AM, Griffin C, Sydenham M, Kirwan CC, et al. Five-year trends and baseline predictors of patient-reported adverse events following breast radiotherapy with a boost in the IMPORT HIGH phase III randomised controlled trial. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2025 Oct;211:111056. PubMed PMID: 40712928. Epub 2025/07/28. eng.