Abstract

The Breast Lesion Excision System® (BLES®) is a stereotactic vacuum-assisted breast biopsy device that utilizes radiofrequency in order to excise non-palpable mammographic lesions for pathologic diagnosis. The purpose of this study was to evaluate the efficacy of BLES® in performing complete, margin-free excisions of small solid carcinomas. Our retrospective study of prospectively enrolled patients included 50 cases of non-palpable, BIRADS≥4, solid by means of mammography and sonography, lesions. All these patients underwent a BLES® breast biopsy procedure from June 2010 to June 2014 and had a malignant diagnosis. According to each patient's pathologic diagnosis, appropriate surgical treatment was recommended. Postoperatively, surgical specimens were histologically analyzed, aiming to determine whether residual malignant disease was present in the specimen cavity formatted by BLES®. Ductal carcinoma in situ (DCIS) was diagnosed in 5 patients and invasive carcinoma (IC) in 45 patients, at primary BLES® pathology report. Tumor-free resection margins (<0.5 and<1mm) were accomplished in only 8/24 subcentimeter cases (33.3%). Absence of residual disease upon surgical excision was confirmed in 23/24 subcentimeter cases (95.8%) and 2/26 of the cases measuring>1cm (7.69%). Statistical analysis revealed that mammographic size was the only significant prognostic factor for complete excision (i.e., with no residual disease in the biopsy cavity) of a malignant lesion. Our results indicate that it is possible, when using the BLES® device, to completely excise small (≤10mm) breast carcinomas that appear radiologically as solid lesions. This subset of patients should be investigated regarding the therapeutic potential of this method.

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