Keshtgar, Mohammed R S2; Williams, Norman R3; Bulsara, Max3; Saunders, Christobel3; Flyger, Henrik1; Cardoso, Jaime S3; Corica, Tammy3; Bentzon, Neils3; Michalopoulos, Nikolaos V3; Joseph, David J3
1 Breast Surgery, Herlev and Gentofte Hospital, The Capital Region of Denmark2 University College of London3 unknown
results from a randomised controlled trial
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.
Breast Cancer Research and Treatment, 2013, Vol 140, Issue 3, p. 519-25
Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't