Abstract

Abstract Background: Breast-conserving surgery for palpable breast cancer is worldwide associated with a high rate of tumour-involved margins and excessive healthy tissue resection. This results in additional treatment and poor cosmetic outcome. Ultrasound-guided surgery (USS) may resolve both problems by improving surgical accuracy. A randomised controlled trial was initiated to compare USS with the standard palpation-guided surgery (PGS) for palpable breast cancer. Methods: A total of 134 eligible patients with palpable T1-T2 invasive breast cancer were randomised to either USS (n = 65) or PGS (n = 69). Outcome measures included resection margin status, re-excision rates, mastectomy rates and additional radiotherapy. A calculated resection ratio (CRR) was derived from specimen volumes and tumour diameters, indicating healthy tissue resection. Secondary outcome measures were operative time, complications cosmetic outcome and cost-effectiveness. The costs of purchasing the US-system were included in the USS-group. The mean total costs per patient were calculated and compared between both study groups. Results: In the USS-group, 3.1% of margins were involved, compared with 17.4% in the PGS-group (p = 0.009). The use of intra-operative US resulted in a significant reduction in additional therapies (p = 0.015); in the PGS-group re-excisions were necessary in 3 patients (4.3%) and in 1 patient (1.5%) in the USS-group, mastectomies were performed in 5 patients (7.2%) of the PGS-group and in none of the patients of the USS-group, and additional radiotherapy boosts in 11 patients (15.9%) of the PGS-group and 6 patients in the USS-group (9.2%). Excision volumes and CRR were both reduced with USS (38cc vs. 58cc and 1.0 vs. 1.7, respectively; both P < 0.002). Analysis of cosmetic self-evaluation after 3 months showed better nipple position in the USS-group compared to the PGS-group (p = 0.016). Furthermore, 3 months after surgery, patients in the USS were more satisfied with the appearance of their breasts than in the PGS group (p = 0.015). Panel evaluation of cosmetic outcome will be conducted in the future. Mean extra costs per patient due to margin involvement in the PGS-group were 446€ compared with 169€ in the USS-group. Yearly costs of a US-system are 8,286€. Therefore, USS for palpable breast cancer can save a breast unit 277€ per patient after the first 30 operated patients (on a yearly basis). A breast unit operating 200 patients per year can achieve 47.090€ of cost savings. Conclusion: USS can prevent the unacceptably high rate of tumour-involved resection margins in palpable breast cancer excision, thus not only improving oncological and cosmetic outcomes by avoiding subsequent surgery or radiotherapy, but also considerably reducing treatment costs. In addition to palpable breast cancer surgery, USS might be used for non-papable breast cancer surgery, mastectomies and oncoplastic procedures. Therefore even greater cost-savings might be achieved by using a US-system for breast cancer surgery. Long term results of cosmetic outcome and quality of life of this trial are expected in 2013. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr PD04-01.

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