Abstract
PurposeTo assess the feasibility of completely excising small breast cancers using the automated, image-guided, single-pass radiofrequency-based breast lesion excision system (BLES) under ultrasound (US) guidance.MethodsFrom February 2018 to July 2019, 22 patients diagnosed with invasive carcinomas ≤ 15 mm at US and mammography were enrolled in this prospective, multi-center, ethics board-approved study. Patients underwent breast MRI to verify lesion size. BLES-based excision and surgery were performed during the same procedure. Histopathology findings from the BLES procedure and surgery were compared, and total excision findings were assessed.ResultsOf the 22 patients, ten were excluded due to the lesion being > 15 mm and/or being multifocal at MRI, and one due to scheduling issues. The remaining 11 patients underwent BLES excision. Mean diameter of excised lesions at MRI was 11.8 mm (range 8.0–13.9 mm). BLES revealed ten (90.9%) invasive carcinomas of no special type, and one (9.1%) invasive lobular carcinoma. Histopathological results were identical for the needle biopsy, BLES, and surgical specimens for all lesions. None of the BLES excisions were adequate. Margins were usually compromised on both sides of the specimen, indicating that the excised volume was too small. Margin assessment was good for all BLES specimens. One technical complication occurred (retrieval of an empty BLES basket, specimen retrieved during subsequent surgery).ConclusionsBLES allows accurate diagnosis of small invasive breast carcinomas. However, BLES cannot be considered as a therapeutic device for small invasive breast carcinomas due to not achieving adequate excision.
Highlights
Due to a substantial portion of breast cancers being detected at screening, the average size of newly detected breast cancers is decreasing, with 53% of them being below 2 cm [1]
Margin assessment of the breast lesion excision system (BLES) specimens was well possible in all cases and thermal damage had no influence on the evaluation by the pathologist
Previous studies have shown that the BLES is a safe and accurate diagnostic device, and a good alternative to vacuum assisted biopsy and core needle biopsy (CNB) [9, 10, 15, 16]
Summary
Due to a substantial portion of breast cancers being detected at screening, the average size of newly detected breast cancers is decreasing, with 53% of them being below 2 cm [1]. Breast conserving therapy (BCT), including wide local excision and radiation therapy, has largely replaced mastectomy [2]. The trend towards BCT has been set despite clear evidence that local surgical excision alone frequently leaves residual cancer deposits in the breast [3, 4]. Since the addition of radiation therapy decreases the local recurrence risk, BCT is as safe as mastectomy [5, 6]. Residual cancer in the resection margin is predictive for recurrence, which results in poorer overall survival [6]. Assessment of tumor involvement of the surgical resection margin has become standard of care [7]
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