ArticleRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2019
Can patient-reported outcomes be used instead of clinician-reported outcomes and photographs as primary endpoints of late normal tissue effects in breast radiotherapy trials? Results from the IMPORT LOW trial.
Article in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Comparison of adverse events in partial- or whole breast radiotherapy: investigation of cosmesis, toxicities and quality of life in a meta-analysis of randomized trials.Radiation oncology (London, England) · 2023Pooled it
- Partial breast irradiation versus whole breast radiotherapy for early breast cancer.The Cochrane database of systematic reviews · 2021Pooled it
- A systematic review and meta-analysis of clinician-reported versus patient-reported outcomes of radiation dermatitis.Breast (Edinburgh, Scotland) · 2020Pooled it
- One versus three weeks hypofractionated whole breast radiotherapy for early breast cancer treatment: the FAST-Forward phase III RCT.Health technology assessment (Winchester, England) · 2023Trial
- Chest wall pain as a late effect following radiotherapy for breast cancer: A systematic review of prevalence and risk factors.Technical innovations & patient support in radiation oncology · 2026Review
- Trajectories and risk factors for long-term breast symptoms following breast-conserving surgery and radiotherapy: a single centre analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Article
- Do skin bacteriostatic agents reduce acute radiodermatitis in breast cancer patients? A prospective interventional study.PloS one · 2025Article
- Do Patient-Reported Outcome Measures (PROMs) Used Within Radiotherapy Clinical Trials Reflect the Impact of Treatment?Cancers · 2024Review
- Acute skin toxicity and self-management ability among Chinese breast cancer radiotherapy patients: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Article
- Implementation of 26 Gy in five fractions over 1 week adjuvant radiotherapy for breast cancer: Prospective report of acute skin toxicity and consideration of resource implications.Breast (Edinburgh, Scotland) · 2023Article
- Validation of a Patient-Reported Outcome Measure for Moist Desquamation among Breast Radiotherapy Patients.Current oncology (Toronto, Ont.) · 2022Article
- Article
- A meta-analysis of the efficacy and safety of accelerated partial breast irradiation versus whole-breast irradiation for early-stage breast cancer.Radiation oncology (London, England) · 2021Review
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- Article
- Is breast seroma after tumour resection associated with patient-reported breast appearance change following radiotherapy? Results from the IMPORT HIGH (CRUK/06/003) trial.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2019Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundIn an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normal-tissue effects (NTE) need to be balanced against risk of relapse. NTE are assessed using patient-reported outcome measures (PROMs), clinician-reported outcomes (CRO) and photographs. This analysis investigates whether PROMs can be used as primary NTE endpoints in breast radiotherapy trials.
methodsAnalyses were conducted within IMPORT LOW (ISRCTN12852634) at 2 and 5 years. NTE were recorded by CRO, photographs and PROMs. Measures of agreement tested concordance, risk ratios for radiotherapy groups were compared, and influence of baseline characteristics on concordance investigated.
resultsIn 1095 patients who consented to PROMS and photographs, PROMs were available at 2 and/or 5 years for 976 patients, of whom 909 had CRO and 844 had photographs. Few patients had moderate/marked NTE, irrespective of method used (eg. 19% patients and 9% clinicians reported breast shrinkage at year-5). Patients reported more NTE than assessed from CRO or photographs (p < 0.001 for most NTE). Concordance between assessments was poor on an individual patient level; eg. for year-5 breast shrinkage, % agreement = 48% and weighted kappa = 0.17. Risk ratios comparing radiotherapy schedules were consistent between PROMs and CRO or photographs.
conclusionsFew patients had moderate/marked NTE irrespective of method used. Patients reported more NTE than CRO and photographs, therefore NTE may be underestimated if PROMs are not used. Despite poor concordance between methods, effect sizes from PROMs were consistent with CRO and photographs, suggesting PROMs can be used as primary NTE endpoints in breast radiotherapy trials.
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