PMID- 30532984
OWN - NLM
STAT- MEDLINE
DCOM- 20191219
LR  - 20240210
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 37
IP  - 4
DP  - 2019 Feb 1
TI  - 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.
PG  - 305-317
LID - 10.1200/JCO.18.00982 [doi]
AB  - 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.
FAU - Bhattacharya, Indrani S
AU  - Bhattacharya IS
AD  - The Institute of Cancer Research, London, United Kingdom.
FAU - Haviland, Joanne S
AU  - Haviland JS
AD  - The Institute of Cancer Research, London, United Kingdom.
FAU - Kirby, Anna M
AU  - Kirby AM
AD  - The Institute of Cancer Research, London, United Kingdom.
AD  - Royal Marsden National Health Service Foundation Trust, London, United Kingdom.
FAU - Kirwan, Cliona C
AU  - Kirwan CC
AD  - University of Manchester and University Hospital of South Manchester, Manchester, 
      United Kingdom.
FAU - Hopwood, Penelope
AU  - Hopwood P
AD  - The Institute of Cancer Research, London, United Kingdom.
FAU - Yarnold, John R
AU  - Yarnold JR
AD  - The Institute of Cancer Research, London, United Kingdom.
FAU - Bliss, Judith M
AU  - Bliss JM
AD  - The Institute of Cancer Research, London, United Kingdom.
FAU - Coles, Charlotte E
AU  - Coles CE
AD  - Cambridge University, Cambridge, United Kingdom.
CN  - IMPORT Trialists
LA  - eng
SI  - ISRCTN/ISRCTN12852634
GR  - NIHR-CS-011-014/DH_/Department of Health/United Kingdom
GR  - C1491/A6035/CRUK_/Cancer Research UK/United Kingdom
GR  - NIHR300024/DH_/Department of Health/United Kingdom
GR  - C1491/A8895/CRUK_/Cancer Research UK/United Kingdom
GR  - 21752/CRUK_/Cancer Research UK/United Kingdom
GR  - 19727/CRUK_/Cancer Research UK/United Kingdom
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181211
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
CIN - Strahlenther Onkol. 2019 Aug;195(8):767-768. PMID: 31001645
MH  - Aged
MH  - Anxiety/epidemiology
MH  - Body Image
MH  - Breast Neoplasms/epidemiology/pathology/*radiotherapy
MH  - Depression/diagnosis/epidemiology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Longitudinal Studies
MH  - Middle Aged
MH  - *Patient Reported Outcome Measures
MH  - Prevalence
MH  - Quality of Life
MH  - *Radiation Dose Hypofractionation
MH  - Radiation Injuries/epidemiology
MH  - Radiotherapy, Adjuvant
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC6357225
EDAT- 2018/12/12 06:00
MHDA- 2019/12/20 06:00
PMCR- 2018/12/11
CRDT- 2018/12/12 06:00
PHST- 2018/12/12 06:00 [pubmed]
PHST- 2019/12/20 06:00 [medline]
PHST- 2018/12/12 06:00 [entrez]
PHST- 2018/12/11 00:00 [pmc-release]
AID - 1800982 [pii]
AID - 10.1200/JCO.18.00982 [doi]
PST - ppublish
SO  - J Clin Oncol. 2019 Feb 1;37(4):305-317. doi: 10.1200/JCO.18.00982. Epub 2018 Dec 
      11.