Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial.
Bhattacharya, Indrani S
Haviland, Joanne S
Kirby, Anna M
Yarnold, John R
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
American Society of Clinical Oncology
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Bhattacharya, I. S., Haviland, J. S., Kirby, A. M., Kirwan, C. C., Hopwood, P., Yarnold, J. R., Bliss, J. M., et al. (2019). Patient-Reported Outcomes Over 5 Years After Whole- or Partial-Breast Radiotherapy: Longitudinal Analysis of the IMPORT LOW (CRUK/06/003) Phase III Randomized Controlled Trial.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 37 (4), 305-317. https://doi.org/10.1200/jco.18.00982
Purpose IMPORT LOW demonstrated non-inferiority of partial-breast and reduced-dose radiotherapy versus whole-breast for local relapse, and similar or reduced toxicity at 5 years. Comprehensive patient reported outcome measures (PROMs) collected at serial time-points are now reported. Methods IMPORT LOW (ISRCTN12852634) recruited women with low-risk breast cancer after breast conserving surgery. Patients were randomly assigned to 40Gy whole-breast radiotherapy (control), 36Gy whole-breast and 40Gy to partial-breast (reduced-dose), or 40Gy to partial-breast only (partial-breast) in 15 fractions. EORTC QLQ-C30, QLQ-BR23, Body Image Scale, protocol-specific items and Hospital Anxiety and Depression Scales were administered at baseline, 6 months, 1, 2 and 5 years. Patterns of moderate/marked adverse effects (AE) were assessed using longitudinal regression models and baseline predictors were investigated. Results 41/71 centres participated in the PROMs sub-study and 1265/1333 (95%) of patients consented. 557/962 (58%) reported no moderate/marked AEs at 5 years. Breast appearance change was most prevalent and persisted over time (around 20% at each time-point). Prevalence of breast hardness, pain, oversensitivity, oedema and skin changes reduced over time (p<0.001 for each), whereas breast shrinkage increased (p<0.001). Analysis by treatment group showed average number of AEs per person was lower in partial-breast (incidence rate ratio [IRR] 0.77, 95%CI 0.71-0.84, p<0.001) and reduced-dose (IRR 0.83, 95%CI 0.76-0.90, p<0.001) versus whole-breast, and decreased over time in all groups. Younger age, larger breast size/surgical deficit, lymph node positivity, and higher levels of anxiety/depression were baseline predictors of subsequent AE reporting. Conclusion Most AEs reduced over time, with fewer AEs in the partial and reduced-dose groups. Baseline predictors for AE reporting were identified. These findings will facilitate informed discussion and shared-decision making for future patients receiving moderately hypofractionated breast radiotherapy.
IMPORT Trialists, Humans, Breast Neoplasms, Radiation Injuries, Treatment Outcome, Radiotherapy, Adjuvant, Incidence, Prevalence, Risk Assessment, Risk Factors, Longitudinal Studies, Depression, Anxiety, Body Image, Time Factors, Quality of Life, Aged, Middle Aged, Female, Patient Reported Outcome Measures, Radiation Dose Hypofractionation
We acknowledge support from Cancer Research UK (grant number C1491/A6035), the National Institute for Health Research (NIHR) Cancer Research Network (CRN), National Health Service Research Scotland, Health and Care Research Wales and the National Institute of Health Research Royal Marsden/ Institute of Cancer Research Biomedical Research Centre. In addition Dr Charlotte Coles is supported by the Cambridge National Institute of Health Research Biomedical Research Centre. Dr Indrani Bhattacharya is supported by a Cancer Research UK clinical trial fellowship (C1491/A8895).
External DOI: https://doi.org/10.1200/jco.18.00982
This record's URL: https://www.repository.cam.ac.uk/handle/1810/288038
Attribution 4.0 International
Licence URL: https://creativecommons.org/licenses/by/4.0/