Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomised controlled trial
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The international randomised targeted intraoperative radiotherapy (TARGIT) trial has demonstrated evidence of non-inferiority between the novel technique of TARGIT (intra-operative radiotherapy with Intrabeam®) and conventional external beam radiotherapy (EBRT) in women with early breast cancer in terms of the primary outcome measure of risk of local relapse within the treated breast. Cosmesis is an increasingly important outcome of breast conserving treatment with both surgery and radiotherapy contributing to this. It was unknown if the single high dose of TARGIT may lead to damaging fibrosis and thus impair cosmesis further, so we objectively evaluated the aesthetic outcome of patients within the TARGIT randomised controlled trial. We have used an objective assessment tool for evaluation of cosmetic outcome. Frontal digital photographs were taken at baseline (before TARGIT or EBRT) and yearly thereafter for up to 5 years. The photographs were analysed by BCCT.core, a validated software which produces a composite score based on symmetry, colour and scar. 342 patients were assessed, median age at baseline 64 years (IQR 59–68). The scores were dichotomised into Excellent and Good (EG), and Fair and Poor (FP). There were statistically significant increases in the odds of having an outcome of EG for patients in the TARGIT group relative to the EBRT group at year 1 (OR 2.07, 95 % CI 1.12–3.85, p = 0.021) and year 2 (OR 2.11, 95 % CI 1.0–4.45, p = 0.05). Following a totally objective assessment in a randomised setting, the aesthetic outcome of patients demonstrates that those treated with TARGIT have a superior cosmetic result to those patients who received conventional external beam radiotherapy.
KeywordsBreast cancer Intra-operative radiotherapy TARGIT Cosmesis
The main TARGIT A Trial is funded by the HTA (project ref 07/60/49) ISRCTN34086741 and sites in Australia were funded by a project grant awarded by the National Health and Medical Research Council. The authors thank the TARGIT Trialists’ Group for the TARGIT A Trial.
Conflict of interest
Carl Zeiss (the manufacturer of the Intrabeam system) covers travelling expenses for meetings of the TARGIT Trial International Steering Committee and conferences where a presentation about Targeted Intraoperative Radiotherapy is being made.
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