dc.contributor.author | Bhattacharya, IS | |
dc.contributor.author | Haviland, JS | |
dc.contributor.author | Kirby, AM | |
dc.contributor.author | Kirwan, CC | |
dc.contributor.author | Hopwood, P | |
dc.contributor.author | Yarnold, JR | |
dc.contributor.author | Bliss, JM | |
dc.contributor.author | Coles, CE | |
dc.contributor.author | IMPORT Trialists | |
dc.date.accessioned | 2018-11-07T16:22:05Z | |
dc.date.issued | 2019-02 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019, 37 (4), pp. 305 - 317 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2920 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.18.00982 | |
dc.description.abstract | Purpose IMPORT LOW demonstrated noninferiority of partial-breast and reduced-dose radiotherapy versus whole-breast radiotherapy for local relapse and similar or reduced toxicity at 5 years. Comprehensive patient-reported outcome measures collected at serial time points are now reported.Patients and methods IMPORT LOW recruited women with low-risk breast cancer after breast-conserving surgery. Patients were randomly assigned to 40 Gy whole-breast radiotherapy (control), 36 Gy whole-breast and 40 Gy partial-breast radiotherapy (reduced-dose), or 40 Gy partial-breast radiotherapy only (partial-breast) in 15 fractions. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 and Breast Cancer-Specific Module, Body Image Scale, protocol-specific items, and the Hospital Anxiety and Depression Scale were administered at baseline, 6 months, and 1, 2, and 5 years. Patterns of moderate/marked adverse effects (AEs) were assessed using longitudinal regression models, and baseline predictors were investigated.Results A total of 41 of 71 centers participated in the patient-reported outcome measures substudy; 1,265 (95%) of 1,333 patients consented, and 557 (58%) of 962 reported no moderate/marked AEs at 5 years. Breast appearance change was most prevalent and persisted over time (approximately 20% at each time point). Prevalence of breast hardness, pain, oversensitivity, edema, and skin changes reduced over time ( P < .001 for each), whereas breast shrinkage increased ( P < .001). Analysis by treatment group showed average number of AEs per person was lower in partial-breast (incidence rate ratio, 0.77; 95% CI, 0.71 to 0.84; P < .001) and reduced-dose (incidence rate ratio, 0.83; 95% CI, 0.76 to 0.90; P < .001) versus whole-breast group 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-breast 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. | |
dc.format | Print-Electronic | |
dc.format.extent | 305 - 317 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | IMPORT Trialists | |
dc.subject | Humans | |
dc.subject | Breast Neoplasms | |
dc.subject | Radiation Injuries | |
dc.subject | Treatment Outcome | |
dc.subject | Radiotherapy, Adjuvant | |
dc.subject | Incidence | |
dc.subject | Prevalence | |
dc.subject | Risk Assessment | |
dc.subject | Risk Factors | |
dc.subject | Longitudinal Studies | |
dc.subject | Depression | |
dc.subject | Anxiety | |
dc.subject | Body Image | |
dc.subject | Time Factors | |
dc.subject | Quality of Life | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Patient Reported Outcome Measures | |
dc.subject | Radiation Dose Hypofractionation | |
dc.title | 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-09-27 | |
rioxxterms.versionofrecord | 10.1200/jco.18.00982 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-02 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 4 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 37 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | en_US |
icr.researchteam | Breast Cancer Radiotherapy | en_US |
dc.contributor.icrauthor | Bliss, Judith | |
dc.contributor.icrauthor | Bhattacharya, Indrani | |
dc.contributor.icrauthor | Kirby, Anna | |
dc.contributor.icrauthor | Yarnold, John | |
dc.contributor.icrauthor | Haviland, Joanne | |