Performance and role of the breast lesion excision system (BLES) in small clusters of suspicious microcalcifications

Performance and role of the breast lesion excision system (BLES) in small clusters of suspicious microcalcifications

European Journal of Radiology 85 (2016) 143–149 Contents lists available at ScienceDirect European Journal of Radiology journal homepage: www.elsevi...

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European Journal of Radiology 85 (2016) 143–149

Contents lists available at ScienceDirect

European Journal of Radiology journal homepage: www.elsevier.com/locate/ejrad

Performance and role of the breast lesion excision system (BLES) in small clusters of suspicious microcalcifications Scaperrotta Gianfranco a,∗ , Ferranti Claudio a , Capalbo Emanuela a , Paolini Biagio b , Marchesini Monica a , Suman Laura a , Folini Cristina a , Mariani Luigi c , Panizza Pietro a a

Department of Breast Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy Department of Diagnostic Pathology and Laboratory, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy c Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy b

a r t i c l e

i n f o

Article history: Received 7 June 2015 Received in revised form 27 October 2015 Accepted 2 November 2015 Keywords: Breast neoplasms Carcinoma Intraductal Image-guided biopsy Resection margins

a b s t r a c t Purpose: To assess the diagnostic performance of the BLES as a biopsy tool in patients with ≤1 cm clusters of BIRADS 4 microcalcifications, in order to possibly avoid surgical excision in selected patients. Materials: This is a retrospective study of 105 patients undergone to stereotactic breast biopsy with the BLES. It excises a single specimen containing the whole mammographic target, allowing better histological assessment due to preserved architecture. Results: Our case series consists of 41 carcinomas (39%) and 64 benign lesions (61%). Cancer involved the specimen margins in 20/41 cases (48.8%) or was close to them (≤1 mm) in 14 cases (34.1%); margins were disease-free in only 7 DCIS (17.1%). At subsequent excision of 39/41 malignant cases, underestimation occurred for 5/32 DCIS (15.6%), residual disease was found in 15/39 cancers (38.5%) and no cancer in 19/39 cases (48.7%). For DCIS cases, no residual disease occurred for 66.7% G1–G2 cases and for 35.3% G3 cases (P = 0.1556) as well as in 83.3%, 40.0% and 43.8% cases respectively for negative, close and positive BLES margins (P = 0.2576). Conclusions: The BLES is a good option for removal of small clusters of breast microcalcifications, giving better histological interpretation, lower underestimation rates and possibly reducing the need of subsequent surgical excision in selected patients. © 2015 Elsevier Ireland Ltd. All rights reserved.

1. Introduction At present VAB systems under stereotactic guidance are the gold standard for percutaneous biopsy of suspicious breast microcalcifications, [1–5] with reported sensitivity of 98% versus 65–97% of CNB. [4], However their accuracy is hampered by underestimation, that is the finding of more severe disease (upgrade) at surgical excision that may occur after percutaneous diagnoses of atypical hyperplasia or in situ carcinoma; reported rates are 2–40% cases for atypical lobular hyperplasia (ALH) and lobular carcinoma in situ (LCIS) [6], 0–38% cases for atypical ductal hyperplasia (ADH), and

Abbreviations: VAB, vacuum-assisted biopsy; CNB, core-needle biopsy; ALH, atypical lobular hyperplasia; LCIS, lobular carcinoma in situ; ADH, atypical ductal hyperplasia; DCIS, ductal carcinoma in situ; BLES, breast lesion excision system; BI-RADS, Breast Imaging Reporting And Data System; RF, Radio-Frequency; H–E, Haematossylin–Eosyn; G1,2,3, (Malignancy) Grade 1, 2, 3; HIFU, high-intensity focused ultrasound. ∗ Corresponding author. Fax: +39 223902524. E-mail address: [email protected] (S. Gianfranco). http://dx.doi.org/10.1016/j.ejrad.2015.11.001 0720-048X/© 2015 Elsevier Ireland Ltd. All rights reserved.

4–33% for ductal carcinoma in situ (DCIS) [7]. In the meta-analysis by Yu et al. [4] the underestimation rates were 20.9% for ADH and 11.2% for DCIS. Underestimation for VAB systems seems not substantially affected either by the gauge of the needle [8] or the number of the retrieved specimen [9]. The latest available biopsy tool is the Breast Lesion Excision System (BLES) that by means of a radiofrequency cutting system can excise a single specimen measuring on average 21  15 mm containing in most cases the whole mammographic target [10–16]. The removal of an intact lesion with preserved architecture can increase the accuracy of pathologic assessment mainly in the case of pre-neoplastic lesions and low-grade in situ carcinoma. BLES has proved safe, with mostly minor complications [16] and able to decrease the underestimation rates to 9.4% for ADH and 5.2% for DCIS [10]. In prospect, BLES can warrant for complete excision of small benign and selected high-risk lesions instead of surgical excision [12]. The aim of our study was to assess the diagnostic performance of BLES in patients with small clusters of variably suspicious microcalcifications in terms of diagnostic underestimation, as well as

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of margins’ status and completeness of the excision, in order to possibly avoid further surgical excision in selected patients. 2. Materials 2.1. The BLES THE BLES (Intact Medical Corporation, Natick, MA, USA) is a biopsy tool for percutaneous removal of a single gross breast specimen. The BLES procedure has been described in detail elsewhere [10,11]. Briefly, the handle device is mounted on a bracket of the stereotactic table and its 6 gauge probe is inserted into the breast under local anaesthesia through a small skin incision (6–8 mm) and moved under stereotactic guidance to reach the edge of the target; at the distal end of the probe, a capture snare with metallic struts is then activated that in a few seconds advance within the breast to encompass and resect en-bloc a sample of tissue measuring 15 or 20 mm in the longest axis, with the biopsy target included; the capture snare then retracts the specimen out of the breast through the biopsy channel and the skin incision. The cutting system used in the procedure is supplied by Radio-Frequency (RF) electrosurgical power, and haemostasis and clearing of the biopsy cavity is obtained by vacuum-assisted suction. Following specimen radiography to assess the presence of the target lesion and the completeness of the excision, the sample is placed in formalin and sent to the Pathologic Department. Through the biopsy channel a marker clips is deployed in the cavity, then the incision is dressed with steri-strips and compressive bandage is applied. The RF cutting system may interfere with cardiac pacemaker or other implantable electronic devices, so these are absolute contraindications for BLES. Moreover, because of the risk of thermal burn and necrosis, lesions too near the skin or the deep fascia as well as those located in the axilla are not suitable. Finally, it is not recommended to perform BLES in pregnant women and in patients with breast implants, and caution has to be given in patients with anticoagulation therapy and clotting disorders, as with other large needle biopsy systems. Reported complications of BLES include bleeding and haematomas, usually not requiring surgical intervention, and very few cases of wound infection, that resolve with antibiotic therapy. Thermal effects are often found by the pathologist on the surface of the specimen, usually <1 mm in thickness, rarely interfering with the histological assessment: a larger probe can partially obviate this risk by creating a potential separation between the edge of the lesion and the surface artifact [19]. Failure of the procedure is reported in 2.4–4.6% of the cases [11,13] and it occurs because of retrieval of an empty basket or breaking of the metallic struts by RF-induced overheating. 2.2. Our study Our study is a retrospective analysis of 105 patients (mean age of 55 years, range 38–81 years) who between September 2010 and February 2014 underwent stereotactic breast biopsy for single clusters of BI-RADS 4 microcalcifications [17,18] measuring up to 1 cm using the BLES device (Intact Medical Corporation, Natick, MA, USA). No prospective trial comparing VAB and BLES was undertaken; in our experience with VAB devices before BLES was available, we found an underestimation rate for DCIS of 26.5% when biopsying the same type of target: this figure and data from literature were considered for comparison with BLES results. Stereotactic VAB procedures with the Hologic Multicare Platinum Plus prone stereotactic table have been routinely performed since 2006 by three of the Authors, while BLES procedures were all performed by the same radiologist with 20 years of experience

in breast imaging and biopsy. The BLES system was used for the first time in Italy in our department since 2010. The cost of the disposable package for the BLES procedure is approximately 20–30% higher than for the VAB procedure, and both of them are covered by the reimbursement from National Health System (the two procedures have the same code). In this study were included eligible patients of any age scheduled for stereotactic procedures because of clusters of BI-RADS 4 microcalcifications measuring up to 1 cm at mammography, that may be represented by grouped coarse heterogeneous microcalcifications (less worrisome) or fine pleomorphic elements (more suspicious). [17,18] All the patients provided written informed consent to undergo breast biopsy: the radiologist decided to perform the BLES or a traditional VAB procedure after reviewing the patient and her mammography. Exclusion criteria were the technical and patient contraindications to BLES reported in the previous section. Data were recorded about patients’ age, mammographic features, histological findings both at BLES and at subsequent excision for malignant and atypically hyperplasic cases. In malignant cases histological report was reviewed for tumor size (both the invasive and the in situ component), histological subtype and grade 1–3 classification. Given the removal of a single gross specimen by BLES, this was histologically assessed for the margins status, in order to establish if they were disease free (negative) or the disease was near to (<1 mm) (close) or involved one of the margins (positive). The specimens were managed in the Pathology Department as follows: any case was fixed in neutral buffered formalin at 10% for at least 12 h and no more than 24 h. The specimen were inked with Indian ink and then bisected along long axis or sliced as “bread-loaf” depending on their size. After routine processing, histological sections were prepared and stained with Haematossylin–Eosyn (H–E). Most of the patients had subsequent surgical excision at our Institution. Eight patients with DCIS at BLES were treated in other Centers: rough data about surgical follow-up after BLES were collected from 6 patients through phone calls; of the remaining two, one patient had radiotherapy instead of excision and another was lost at follow-up. Overall, histological data are available for 39/41 malignant cases. Comparing BLES results and final histological findings, concordance means that the same BLES pathological diagnosis was confirmed at surgical excision; upgrade means that at surgical excision a more severe disease was found as compared with BLES results, that is invasive carcinoma at surgery in case of DCIS or atypical hyperplasia at BLES (and possibly DCIS in case of atypical hyperplasia); downgrade means that: (a) in case of invasive cancer at BLES, no invasive foci were found at surgical excision, but only in situ carcinoma or even no residual disease; (b) after a diagnosis of DCIS at BLES, no residual disease was found at surgical excision. The results obtained by BLES and by subsequent excision were tabulated by means of contingency tables reporting absolute frequencies. Statistical analysis was applied to the subset of DCIS cases at BLES, comparing margins’ status and malignancy grade with the outcome at subsequent surgical excision. The significancy level was set at p < 0.05.

3. Results The histological assessment on specimens obtained by the 105 BLES procedures showed 41 malignant lesions (39.0%), consisting in 3 invasive carcinomas, 4 DCIS with micro-invasion and 34 pure DCIS, and 64 benign lesions (61,0%) including 7 cases of atypical ductal or columnar cell lesions Table 1. Table 2 highlights the margin status at BLES and the surgical outcome for the 41 malignant lesions. Among the 3 invasive cases

S. Gianfranco et al. / European Journal of Radiology 85 (2016) 143–149 Table 1 Histological data of BLES case series. Histology

N◦ cases

%

Invasive carcinoma DCIS with micro-invasion G3 DCIS G1 + G2 DCIS Malignant lesions Atypical hyperplasia Dysplastic changes Fibroadenoma Papilloma Benign N.O.S. Benign lesions TOTAL

3 4 14 20 41 7 45 7 3 2 64 105

2.9 3.8 13.3 19.0 39.0 6.7 42.8 6.7 2.9 1.9 61.0 100.0

(2.9%), cancer was found at the resection margin in 1 case and close to it (≤1 mm) in the other 2 cases. At surgical excision, residual 3 mm invasive cancer was found in the first case, only 6 mm DCIS plus LCIS in the second case, and no evidence of residual cancer in the third case. Among the 4 DCIS with micro-invasion (invasive focus ≤1 mm) (3.8%), resection margins were positive in 3 cases and close in the fourth case. At surgical excision, in the 3 cases with positive margins residual DCIS with micro-invasion was still found in one case, DCIS in the second patient, while no evidence of residual cancer was found in the third case, as well as in the fourth case with close margins. Among the 34 pure DCIS cases (32.3%), cancer involved the specimen margins in 16 cases (47.0%), was close to them in 11 cases (32.4%), while margins were disease-free in 7 cases (20.6%) (Figs. 1 and 2). Information about the subsequent surgical excision was available for 32/34 patients: micro-foci of invasive cancer were found in 5/32 (15.6%) (upgrade); DCIS was still present in 11 (34.4%) (concordance), while in 16 cases (50.0%) the final histological assessment found respectively ADH (1), papillomatosis (1), dysplastic changes (5) or post-biopsy sequelae (9) (down-grade). Only 2/7 patients with atypical ductal or columnar cell hyperplasia (6.7%) at BLES had subsequent excision resulting in papillomatosis (1) and post-biopsy sequelae (1). The follow-up in the other 5 patients (average 25 months, range 8–44 months) did not reveal adverse events. Overall, residual cancer was found in 15/39 cancers (38.5%), that is in 2/3 invasive cancer, in 2/4 DCIS with micro-invasion and 11/32 pure DCIS. No residual cancer was found 19/39 cancers (48.7%), that is in 1/3 invasive cancer, 2/4 DCIS with micro-invasion and 16/32 DCIS. Upgrade occurred in 5/32 DCIS (15.6%). Residual same disease retrieved by BLES was found at surgical excision in 13/39 cases (33.3%); down-grade of the disease occurred in 21/39 malignant lesions (53.8%), with absence of residual disease in 19/21 cases (90.5%) and 2/21 cases with residual DCIS left behind respectively from 1 invasive carcinoma and 1 DCIS with micro-invasion diagnosed by BLES. In Table 3 we analyzed the BLES results for G1-G2 and G3 DCIS cases as compared with findings at surgical excision, looking at the

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rate of disease clearance by BLES. Cases with no residual disease were 50% overall (C.I. 95%; 31.9–68.1%) while upgrade occurred in 15.6% (C.I. 95%: 5.3–32.8%). Upgrade numbers are too small to allow valuable statistical analysis, and do not suggest any trend. No residual disease was found in 66.7% of G1–G2 DCIS and 35.3% of G3 DCIS (P = 0.1556). When we compared the same outcome according to the BLES margins’ status, the rates were 83.3%, 40.0% and 43.8% respectively for negative, close and positive margins (P = 0.2576). In both analyses, the results did not reach the statistically significance level and express only a trend. No major complications occurred with BLES and patients tolerated well the procedure, probably due to the generous amount of local anaesthesia used. Thermal artefacts were rarely remarked in the histological report (1 benign N.O.S. case), and were not charged for possible interference with pathologic interpretation. In only one case the procedure had to be repeated due to an “empty basket”.

4. Discussion and conclusions Our study supports the view that BLES is a good option for percutaneous stereotactic biopsy of suspicious microcalcifications, allowing better histological interpretation and lower underestimation than VAB systems. After having said that, BLES is not a substitute of VAB, that holds its diagnostic value and has less technical limitations. However, looking at underestimation rates in the literature, VAB systems have probably reached an impassable limit, perhaps due to fragmentation of the target lesion. We think that BLES can carve out its place in selected patients both for diagnostic purposes and possibly reducing the need of subsequent surgical excision for high-risk lesions (atypical epithelial hyperplasia) in the case of complete removal. BLES can be used also for directed percutaneous en-bloc removal of fibroadenomas instead of surgical excision, and we too used ultrasound-guided BLES in some patients with up to 1.5–2 cm fibroadenomas. In our series, underestimation with BLES occurred for 5/32 DCIS (15.6%), a figure that compares well with the series by Seror et al. [13] and better with respect to our previous experience with VAB for the same target (26.5%), but is lower than the impressive results of the first 2 U.S.A. reports. [10,11] Down-grading of the disease occurred in 21/39 malignant lesions (53.8%), with residual disease in only 2/21 cases (9.5%) and dysplastic changes or post-biopsy sequelae in 19 cases (90.5%). Table 4 summarizes the literature evidence about the BLES system. When assessing the BLES as a therapeutic tool, able to completely remove the target lesion without the need of further excision, we have to acknowledge that BLES is significantly more handy and user-friendly than its precursors used in the 90s. The Advanced Breast Biopsy Instrumentation (ABBI) was used also in our Institution [20] but had high costs and

Table 2 Histology and margins’ status of malignant lesions at BLES and finding at subsequent excision. Histology

at BLES

Invasive carcinoma DCIS with micro-invasion G3 DCIS G1 + G2 DCIS Total

N◦ cases

3 4 18 16 41

Findings at subsequent surgery a , b

Margins status at BLES Positive

Close

Negative

Same disease

Upgrade

Down-grade

1 3 11 5 20

2 1 6 5 14

– – 1 6 7

1 1 8 3 13

– – 3 2 5

2 3 6 10 21

Data available for 39/41 malignant cases. a 1 patient with G2 DCIS had not surgery but subsequent radiotherapy. b 1 patient with G3 DCIS was lost at follow up.

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Fig. 1. Female 48 years old. Cluster of BI-RADS 4b microcalcifications measuring 5 mm. Histology: ADH foci and single DCIS G2 at 2 mm from the margin of the BLES specimen. Surgery: no residual disease. 6 1A—MLO view. 7 1B—Scout view for stereotactic localization. 8 1C—radiography of the BLES specimen.

Table 3 Margins’ status for DCIS at BLES and findings at subsequent surgical excision. BLES

Surgical excision

Histology

Margins

DCIS G1–G2(n◦ 16)

Negative Close Positive

DCIS G3 (n◦ 18)

Negative Close Positive

Total a b

Total Same disease(Concordance)

Invasive foci(Upgrade)

NAa

4 3 3

1 1 1

– 1 1

1a

1 1 4

– 3 5

– 1 2

1b

1 6 11

11

5

2

34

No residual disease(Down-grade)

16

6 5 5

1 patient with 3 mm DCIS G2 with negative margins had no subsequent surgery. 1 patient with 3 mm DCIS G3 with close margins was lost at follow-up.

great invasiveness. In spite of such a large specimen, there was no guaranty of disease-free margins in most malignant cases [21]. After its withdrawal from the market in 2002, it was replaced by the Site-Select, that was modified in order to spare the superficial tissues, with better cosmetic result and greater compliance of the patients [22–24]. Looking at BLES results in our study, we found disease involving the margins of the BLES specimen or close to them in 34/41

malignant lesions (82.9%), while the margins were disease-free in only 7 DCIS cases (17.1%). This is not surprising given that the specimen is somewhat oval, measuring 2 cm or more in length but only about 1 cm in thickness, so there is no guaranty to hold the target perfectly in the center of the specimen. We believe that obtaining disease-free margins cannot be the rule with the currently available probes, even for very small clusters of microcalcifications. However, no residual disease was found at surgery in 7/16 (43.8%) DCIS

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Fig. 2. Woman 48 years old. Very small cluster of BI-RADS 4b microcalcifications measuring 4 mm. Histology: DCIS G2 and focal ADH. The in situ lesion is 2.3 mm away from the BLES margin. Surgery: no residual disease. 9 2A—CC view. 10 2B—Spot magnification of the cluster of microcalcifications. 11 2C—Radiography of the BLES specimen.

Table 4 Summary of literature evidence about BLES. Seror et al. [13]

Allen et al. [14]

Medjhoul et al. [15]

Al-Harethee et al. [19]

Allen et al. [14]

Al-Harethee et al. [16]

Period of study % BIRADS ≥4 n◦ lesions % microcalci-fications Mammographic diameter (average)

2002–2004 100% 742a 100% NA

2003–2004 100% 800 100% NA

2006–2010 NA 1170a nearly 100% NA

2008–2010 100% 105 <50% NA

% stereotaxic procedures ADH lesions n◦ (%)

% 34 (4.6%) 3/32 (9.4%) 119 (15.4%) 6/115 (5.2%) NA

% 15 (1.9%) NA

>95% 32 (3.0%) 3/22 (14.0%) NA NA

100% 0 (0%) 0 (0%) 5 (4.7%) NA

2007–2009 0% 76 NA 2–10 mm (7.1 mm) 72.4% 7 (9.2%) 0 (0%) 9 (11.8%) NA

NA

NA

NA

2008–2009 89.8% 166 84.1% 2–25 mm (8.1 mm) 89.2% 12 (7.2%) 0/9 (0%) 27 (16.3%) 6/27 (21.4%) 4/166 (2.4%)

n◦ (%) ADH underestimation n◦ (%)

DCIS lesions

n◦ (%) DCIS underestimation ◦

N (%) failures a

31 (3.9%) 1/31 (3.2%) 37/800 (4.6%)

Multicentre studies.

with positive specimen margins and 4/11 (36.4%) DCIS with close margins, as well as in 2 DCIS with micro-invasion and 1 invasive lobular carcinoma associated with DCIS that had the same margins status. On the contrary, the advantage of BLES can be assignable to better interpretation by the pathologist who is given an intact specimen, differently from the piecemeal retrieval of traditional multi-core VAB systems, a point that can be crucial for differen-

tial diagnosis between atypical hyperplasic lesions and low-grade in situ carcinomas [25–27]. In the field of small breast cancer treatment, non-surgical ablation techniques have been under evaluation in the latest 10 years, particularly RF ablation and High-Intensity Focused Ultrasound (HIFU) both US- and MRI-guided [28,29]. They have promising potential both for local control and cosmetic result; however to

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achieve wide acceptability, their results must be established as equivalent to conventional surgical treatment in terms of local control and survival. Both RF ablation and HIFU procedures have been used for breast cancers measuring 2 cm or even greater, that had to be well visible on US or MRI imaging to allow precise monitoring of the onset of coagulative necrosis in the tumor and its margins. Before the treatment, the malignant mass must be fully assessed histologically and immune-histochemically by core-needle biopsy to obtain cancer phenotype. Obviously, after the treatment the specimen cannot be histologically assessable nor it is possible to establish whether the tumor has been fully destroyed, and another drawback is that the imaging post-procedural evaluation does not ensure that negative margins have been achieved. So, percutaneous lumpectomy (in the case of RF ablation) or subsequent radiotherapy (for HIFU procedures) have been recommended, both for local control and restore patients’ anxiety about the persistence of viable tumor. A practical advantage of BLES on those systems is the availability of an intact specimen to be pathologically analyzed in order to obtain all the useful information necessary for an adequate management of the patients. However the use of BLES in the treatment of invasive breast cancers seems unjustified: it is possible the excision of a malignant mass up to 1.5 cm, but this should not be obviously a radical treatment. So, different from those system, we have addressed the BLES to very small breast lesions characterized by clusters of microcalcifications, that is within the field of pre-neoplastic and in situ disease. Whitworth et al. [12] inferred that when ADH is histologically assessed and the target is completely removed by BLES with radiologic confirmation on post-biopsy mammogram, there is no need of further surgical excision, different from common recommendations based on literature results. In their multicenter study, 32 ADH out of 1170 patients were diagnosed; 10/32 cases met the radiologic and histologic criteria to be considered a subset of patients for potential surgical avoidance. No upgrade occurred at subsequent surgery in this population, different from 14% in the remaining 22/32 patients. Their ADH numbers are greater than those in our study; although they claimed for no possible statistically definitive conclusions, they decided to modify their management of ADH patients, applying to the selected population the same surveillance program suggested for BI-RADS 3 lesions. Some data in our study seem to incite to go a bit beyond: older women with atypical epithelial hyperplasia or lobular neoplasia and even G1–G2 DCIS measuring ≤1 cm with disease-free margins and favorable prognostic parameters, removed in a single specimen by BLES, could be spared subsequent surgical excision. Margins’ status is undoubtedly an important prognostic factor both for local control and survival and possible underestimation must be considered for BLES; however, we believe that in the aforementioned subset of patient a careful scheduling of imaging follow-up should ensure an early detection of possible recurrences for salvage surgical treatment without worsening their prognosis. In the Eastern Cooperative Oncology Group nonrandomized study ECOG E5194 [30] comparing 565 patients with low- or intermediate grade DCIS up to 2.5 cm in size and 105 patients with high-grade DCIS 1 cm or less in size, the 5-year rate of ipsilateral local recurrence was 6.1% versus 15.3% and the 7-year rate was 10.5% versus 18.0%, suggesting that high-grade DCIS is not suitable for treatment with excision without radiotherapy [31]. Our choice of target lesions up to 1 cm is more restrictive than the 2.5 cm parameter considered in the ECOG study for G1–2 DCIS and may imply lower recurrence rates. Our study has a few limitations. First, it is a retrospective observational study and not a prospective study aimed to compare traditional VAB systems and BLES. Second, patients were not consecutively enrolled. Third, the decision to use the BLES procedure instead of the traditional VAB system was entirely based on radi-

ologist’s assessment, so probably a patient selection bias may be conceivable. Fourth, the numbers of DCIS and atypical hyperplasic lesions are small, so we observed only a behavioral trend and not statistically significant differences. Larger prospective studies are needed to assess the validity of our inferences. In conclusion, our study supports the view that the BLES system represents a valuable diagnostic option in the field of percutaneous biopsies of the breast and in expert hands may add something to personalize the management of non-palpable lesions, with the potential for a therapeutic role in selected cases. The BLES system proved sufficiently accurate and safe as a diagnostic tool able to substantially reduce underestimation of disease as compared with traditional VAB devices; we hope that with growing experience and the availability of a bit larger probes, better results may be achieved. Disclosures No conflict of interest and no disclosures. References [1] F. Burbank, S.H. Parker, T.J. Fogerty, Stereotactic breast biopsy: improved tissue harvesting with the Mammotome, Am. Surg. 62 (1996) 738–744. [2] S.H. Parker, F. Burbank, A practical approach to minimally invasive breast biopsy, Radiology 200 (1996) 11–20. [3] K. Fahrbach, I. Sledge, C. Cella, H. Linz, S.D. Ross, A comparison of the accuracy of two minimally invasive breast biopsy methods: a systematic literature review and meta-analysis, Arch. Gynecol. Obstet. 274 (2006) 63–73. [4] Y.-H. Yu, C. Liang, X.-Z. Yuan, Diagnostic value of vacuum-assisted breast biopsy for breast carcinoma: a meta-analysis and systematic review, Breast Cancer Res. Treat. 120 (2) (2010) 469–479, http://dx.doi.org/10.1007/s10549010-0750-1. [5] N. Houssami, S. Ciatto, I. Ellis, D. Ambrogetti, Underestimation of malignancy of breast core-needle biopsy, Cancer 109 (2006) 487–495. [6] H. Hwang, L.D. Barke, E.B. Mendelson, B. Susnik, Atypical lobular hyperplasia and classic lobular carcinoma in situ in core biopsy specimens: routine excision is not necessary, Mod. Pathol. 21 (2008) 1208–1216. [7] C. Forgeard, M. Benchaib, N. Guerin, P. Thiesse, H. Mignotte, C. Faure, C. Clement-Chassagne, I. Treilleux, Is surgical biopsy mandatory in case of atypical ductal hyperplasia on 11-gauge core needle biopsy ? A retrospective syudy of 300 patients, Am. J. Surg. 196 (2008) 339–345. [8] A.P. Lourenco, M.B. Mainiero, E. Lazarus, D. Giri, B. Schepps, Stereotactic breast biopsy: comparison of histologic underestimation rates with 11- and 9-gauge vacuum-assisted breast biopsy, AJR 189 (2007) 275–279. [9] G.C. Zofragos, F. Zagouri, T.N. Sergentanis, D. Koulocheri, A. Nonni, V. Oikonomou, P. Domeyer, M. Kotsani, C. Fotiadis, J. Bramis, Is zero underestimation feasible? Extended vacuum-assisted breast biopsy in solid lesions—a blind study, World J. Surg. Oncol. 5 (2007) 53–60. [10] A. Sie, D.C. Bryan, V. Gaines, L.K. Killebrew, C.H. Kim, C.C. Morrison, W.R. Poller, A.P. Romilly, K. Schilling, J.H. Sung, Multicenter evaluation of the Breast Lesion Excision System, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device, Cancer 107 (5) (2006) 945–949, http://dx.doi.org/10. 1002/cncr.22090. [11] L.K. Killebrew, R.H. Oneson, Comparison of the diagnostic accuracy of a vacuum-assisted percutaneous intact specimen sampling device to a vacuum-assisted core needle sampling device for breast biopsy: initial experience, Breast J. 12 (4) (2006) 302–308, http://dx.doi.org/10.1111/j.1075122X.2006.00268.x. [12] P.W. Whitworth, J.F. Simpson, W.R. Poller, S.M. Schonholtz, J.F. Turner, R.F. Phillips, J.M. Johnson, F.D. McEachin, Definitive diagnosis of high-risk breast lesions without open surgical excision: the Intact Percutaneous Excision Trial (IPET), Ann. Surg. Oncol. 18 (2011) 3047–3052, http://dx.doi.org/10.1245/ s10434-011-1911-0. [13] J.-Y. Seror, B. Lesieur, B. Scheuer-Niro, L. Zerat, R. Rouzier, S. Uzan, Predictive factors for complete excision and underestimation of one-pass en bloc excision of non-palpable breast lesions with the Intact breast lesion excision system, Eur. J. Radiol. 81 (2012) 719–724, http://dx.doi.org/10.1016/j.ejrad. 2011.01.049. [14] S.D. Allen, A. Nerurkar, G.U. Querci Della Rovere, The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? Eur. Radiol. 21 (2011) 919–924, http://dx.doi.org/10.1007/s00330-010-2000-7. [15] A. Medjhoul, S. Canale, M.C. Mathieu, C. Uzan, J.R. Garbay, C. Dromain, C. Balleyguier, Breast Lesion Excision sample (BLES Biopsy) combining stereotactic biopsy and radiofrequency: is it a safe and accurate prodedure in case of BIRADS 4 and 5 breast lesions? Breast J. 19 (2013) 590–594. [16] W. Al-Harethee, G. Theodoropoulos, G.M. Filippakis, I. papapanagiotou, M. Matiatou, G. Georgiou, V. Kalles, D. Koulochri, A. Nonni, M.M. Konstadoulakis,

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