Proposal for a gold standard for cosmetic evaluation after breast conserving therapy: Results from the St George and Wollongong Breast Boost trial.

INTRODUCTION: Breast cosmesis is an important endpoint of breast conserving therapy (BCT), but a gold standard method of its evaluation is not yet established. The St. George and Wollongong Randomised Breast Boost trial used five different methods of cosmetic assessment, including both subjective and objective, to comprehensively evaluate the cosmetic outcome of the trial patients. This current study analyses the level of concordance between these methods in an attempt to determine a possible standard in the evaluation of breast cosmesis. METHODS: Patients attending follow-up clinic reviews at 5 years post breast radiotherapy were evaluated. Patients completed a cosmesis and functional assessment questionnaire, assessing clinicians completed an EORTC (European Organization for Research and Treatment of Cancer) cosmetic rating questionnaire and photographs were obtained. The photographs were later assessed by a panel of five experts, as well as analysed using the objective pBRA (relative Breast Retraction Assessment) and the BCCT.core (Breast Cancer Conservative Treatment.cosmetic results) computer software. Scores were dichotomised to excellent/good and fair/poor. Pairwise comparisons between all methods, except pBRA, were carried out using overall agreement calculations and kappa scores. pBRA scores were compared on a continuous scale with each of the other dichotomised scores obtained by the other four methods. RESULTS: Of 513 St George patients alive at 5 years, 385 (75%) attended St George for follow-up and consented to photography. Results showed that assessment by physicians in clinic and patient self-assessment were more favourable regarding overall cosmetic outcome than evaluation of photographs by the panel or the BCCT.core software. Excellent/good scores by clinician-live and patient self-assessments were 93% and 94% respectively (agreement 89%), as compared to 75% and 74% only by BCCT.core and panel assessments respectively (agreement 83%, kappa 0.57). For the pBRA measurements, there was a statistically significant difference (P <0.001) between scores for excellent/good versus fair/poor cosmesis by all four methods. The range of median pBRA measurements for fair/poor scores was 13.4-14.8 and for excellent/good scores was 8.0-9.4. CONCLUSION: Incorporating both BCCT.core assessment and patient self-assessment could potentially provide the basis of a gold standard method of breast cosmetic evaluation. BCCT.core represents an easy, time efficient, reproducible, cost effective and reliable method, however, it lacks the functional and psychosocial elements of cosmesis that only patient self-reported outcomes can provide.

Breast irradiation causes pallor in the nipple-areolar complex in women with Celtic skin type (result from the St. George and Wollongong randomised breast boost trial).

INTRODUCTION: The nipple-areolar complex (NAC) has special histological properties with higher melanocyte concentration than breast skin. To date, there are no data describing the late effects on the NAC following breast-conserving therapy (BCT). This study evaluated colour changes in the NAC in patients treated with breast-conserving surgery and adjuvant radiotherapy after 5 years. METHODS: Digital photographs obtained at 5 years following breast irradiation from the St. George and Wollongong (SGW) trial (NCT00138814) were evaluated by five experts using an iPad® (Apple Inc., Cupertino, CA, USA) application specifically created for this study. The SGW trial randomised 688 patients with Tis-2, N0-1, M0 carcinoma to the control arm of 50 Gy in 25 fractions and boost arm of 45 Gy in 25 fractions and 16 Gy in 8 fractions electron boost. RESULTS: A total of 141/372 (38%) patients had altered NAC (86% lighter, 10% darker). Patients with Celtic skin type had increased likelihood of having an altered NAC (odds ratio (OR), 1.75 (CI 1.1-2.7, P = 0.011)). On subgroup analysis, those with Celtic skin type receiving biologically equivalent dose (BED) Gy3 ≥ 80 Gy had OR of 3.03 (95% CI 1.2-7.5, P = 0.016) for having altered colour. There was a dose response with more profound changes seen in the NAC compared with irradiated breast skin if BED Gy3 ≥ 80 Gy with OR of 2.42 (95% CI 1.1-5.6, P = 0.036). CONCLUSION: In this Caucasian BCT population, over 30% of patients developed lighter NAC and more commonly in women with Celtic skin type. The degree of this effect increased with higher radiation dose.

Radiotherapy breast boost with reduced whole-breast dose is associated with improved cosmesis: the results of a comprehensive assessment from the St. George and Wollongong randomized breast boost trial.

PURPOSE: To evaluate comprehensively the effect of a radiotherapy boost on breast cosmetic outcomes after 5 years in patients treated with breast-conserving surgery. METHODS: The St. George and Wollongong trial (NCT00138814) randomized 688 patients with histologically proven Tis-2, N 0-1, M0 carcinoma to the control arm of 50 Gy in 25 fractions (342 patients) and the boost arm of 45 Gy in 25 fractions to the whole breast followed by a 16 Gy in 8 fraction electron boost (346 patients). Five-year cosmetic outcomes were assessed by a panel subjectively in 385 patients and objectively using pBRA (relative breast retraction assessment). A subset of patients also had absolute BRA measurements. Clinician assessment and patient self-assessment of overall cosmetic and specific items as well as computer BCCT.core analysis were also performed. RESULTS: The boost arm had improved cosmetic overall outcomes as scored by the panel and BCCT.core software with 79% (p = 0.016) and 81% (p = 0.004) excellent/good cosmesis respectively compared with 68% in no-boost arm. The boost arm also had lower pBRA and BRA values with a mean difference of 0.60 and 1.82 mm, respectively, but was not statistically significant. There was a very high proportion of overall excellent/good cosmetic outcome in 95% and 93% in the boost and no-boost arms using patient self-assessment. However, no difference in overall and specific items scored by clinician assessment and patient self-assessment was found. CONCLUSION: The results show the negative cosmetic effect of a 16-Gy boost is offset by a lower whole-breast dose of 45 Gy.

Evaluating key dimensions of the breast care nurse role in Australia.

A survey of women who had surgery for breast cancer during 1997-1998 at The St George Public and St George Private Hospitals identified substantial deficits in information provision, perceived support, and use of available services. Consequently, a breast care nurse (BCN) was appointed for a 12-month trial to assess women's needs and provide emotional support, education, and referral to appropriate services from diagnosis through to completion of treatment, according to evidence-based guidelines set out by the Australian National Breast Cancer Centre. A questionnaire regarding the role of the BCN was sent to 63 women who had surgery at either hospital from September 1999 to January 2000. Fifty women responded, for a 79% response rate. Ninety percent of respondents reported that it was helpful to talk to the BCN and rated verbal information given as helpful. Women accessed significantly more services than reported in 1998, and disparities in service use by age and public/private sector were eliminated. These results show strong consumer endorsement of service provision by the BCN. During this 12-month trial, consumer demand resulted in service expansion from 24 hours per week to 80. Ongoing evaluation of this developing role is required to ensure that women's needs are managed optimally.