P265 Cosmetic outcome one, two, three and four years after intra-operative radiotherapy compared with external beam radiotherapy for early breast cancer: an objective assessment of patients from a randomised controlled trial

94 Background: The randomized controlled TARGIT Trial was designed to determine noninferiority between the novel technique of TARGIT [intra-operative radiotherapy with Intrabeam (Carl Zeiss, Germany)] and conventional external beam radiotherapy (EBRT) in women with early breast cancer. The main outcome objective is risk of local relapse within the treated breast. We report here data from a subprotocol assessing cosmesis in 114 women over 50 years old participating in the TARGIT Trial from one center (Perth, Australia). Methods: Frontal view digital photographs from were assessed, blind to treatment, using specialist software (BCCT.core 2.0, INESC Porto, Portugal) that produces an objective composite score based on symmetry, color, and scar. Data on patient and tumor characteristics were obtained from hospital notes. Statistical analysis was by generalized estimating equations (GEE) on all data, and logistic regression analysis at year 1 only. Results: Photographs were taken at baseline (before surgery) and 1, 2, 3, and 4 years after initial breast-conserving surgery; none of the 114 patients had subsequent breast surgery. Median age at randomization was 62 years (IQR 56 to 68). The composite scores were dichotomized into Excellent and Good (EG), and Fair and Poor (FP). There was a nonsignificant 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 tumor grade and age of the patient. For year 1 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, tumor size, and grade. Conclusions: These results confirm a significantly better cosmetic outcome with TARGIT compared to EBRT in the first year after surgery.

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Cosmetic outcome after intraoperative radiotherapy or external beam radiotherapy for early breast cancer: An objective assessment of patients from a randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.1110 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 1110-1110

Author(s):

Mohammed R. Keshtgar ◽

Norman R. Williams ◽

Tammy Corica ◽

Max Bulsara ◽

Christobel Saunders ◽

...

Keyword(s):

Breast Cancer ◽

Early Breast Cancer ◽

Assessment Tool ◽

Controlled Trial ◽

External Beam Radiotherapy ◽

Objective Assessment ◽

Intraoperative Radiotherapy ◽

Cosmetic Outcome ◽

High Dose ◽

External Beam

1110 Background: The international randomised contolled TARGeted Intraoperative radioTherapy (TARGIT) trial has demonstrated non-inferiority between the novel technique of TARGIT (intra-operative radiotherapy with Intrabeam) and conventional whole-breast 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. With very low recurrence rates, cosmesis becomes an increasingly important outcome of breast conserving treatment with both surgery and radiotherapy. This study was performed to determine if the single high dose of TARGIT leads to impaired cosmesis. Methods: A validated, objective assessment tool for evaluation of cosmetic outcome was used. Frontal digital photographs were taken at baseline (before TARGIT or EBRT) and yearly thereafter for up to five years. The photographs were analysed by BCCT.core software which produces a composite score based on symmetry, colour and scar. Results: 342 patients were assessed, all over 50 years old with a median age at baseline of 64 years (IQR 59 to 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 to 3.85, p = 0.021) and year 2 (OR = 2.11, 95%CI 1.0 to 4.45, p = 0.05). Conclusions: Following an objective assessment of aesthetic outcome in patients from a randomised setting, this study demonstrates that those treated with targeted intraoperative radiotherapy have a superior cosmetic result compared with those patients who received conventional whole-breast external beam radiotherapy.

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Cosmetic outcome after intraoperative radiotherapy or external beam radiotherapy for early breast cancer: An objective assessment of patients from a randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.26_suppl.59 ◽

2013 ◽

Vol 31 (26_suppl) ◽

pp. 59-59

Author(s):

Mohammed R. Keshtgar ◽

Norman R. Williams ◽

Tammy Corica ◽

Max Bulsara ◽

Christobel Saunders ◽

...

Keyword(s):

Breast Cancer ◽

Early Breast Cancer ◽

Assessment Tool ◽

Controlled Trial ◽

External Beam Radiotherapy ◽

Objective Assessment ◽

Intraoperative Radiotherapy ◽

Cosmetic Outcome ◽

High Dose ◽

External Beam

59 Background: The international randomised contolled TARGeted Intraoperative radioTherapy (TARGIT) trial has demonstrated non-inferiority between the novel technique of TARGIT (intra-operative radiotherapy with Intrabeam) and conventional whole-breast 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. With very low recurrence rates, cosmesis becomes an increasingly important outcome of breast conserving treatment with both surgery and radiotherapy. This study was performed to determine if the single high dose of TARGIT leads to impaired cosmesis. Methods: A validated, objective assessment tool for evaluation of cosmetic outcome was used. Frontal digital photographs were taken at baseline (before TARGIT or EBRT) and yearly thereafter for up to five years. The photographs were analysed by BCCT.core software which produces a composite score based on symmetry, colour and scar. Results: 342 patients were assessed, all over 50 years old with a median age at baseline of 64 years (IQR 59 to 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 to 3.85, p = 0.021) and year 2 (OR = 2.11, 95% CI 1.0 to 4.45, p = 0.05). Conclusions: Following an objective assessment of aesthetic outcome in patients from a randomised setting, this study demonstrates that those treated with targeted intraoperative radiotherapy have a superior cosmetic result compared with those patients who received conventional whole-breast external beam radiotherapy.

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