Background:

The international randomised controlled TARGIT Trial (ISRCTN 34086741) was designed to determine non-inferiority between the risk-adaptive approach of TARGIT [intra-operative radiotherapy with Intrabeam® (Carl Zeiss, Germany)] and conventional external beam radiotherapy (EBRT) in women with early breast cancer. The primary endpoint is risk of local relapse within the treated breast. We report here data from a sub-protocol assessing cosmesis in 114 women over 50 years participating in the TARGIT Trial from one centre (Perth, Australia).

Material andMethods:

Frontal view digital photographs from were assessed, blind to treatment, using specialist software (BCCT.core 2.0, INESC Porto, Portugal) which produces a composite score based on symmetry, colour and scar. Statistical analysis was by generalised estimating equations (GEE) on all of the data, and logistic regression analysis at year 1.

Results:

Images from 114 patients have been assessed, 59 and 55 randomised to IORT and EBRT, respectively. Median age at randomisation was 62 years (IQR 56 to 68). Photographs were taken at baseline (before surgery) and one, two, three and four years after initial breast conserving surgery; none had subsequent breast surgery. The scores were dichotomised into Excellent and Good (EG), and Fair and Poor (FP). There was a non-significant 45% increase in the odds of having an outcome of EG for patients in the TARGIT group relative to the EBRT group (OR=1.45, 95% CI 0.78–2.69, p = 0.245) after adjusting for tumour size. The results were similar when adjusted for tumour grade and age of the patient. For year 1 only there was a statistically significant 2.35 fold increase in the odds of having an outcome of EG for patients in the TARGIT group relative to the EBRT group (OR=2.35, 95% CI 1.02–5.45, p = 0.047) after adjusting for age of the patient, tumour size and grade.

Conclusions:

These results demonstrate a significantly better cosmetic outcome with TARGIT compared to EBRT in the first year after surgery.