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01-10-2011 | AMERICAN SOCIETY OF BREAST SURGEONS

Definitive Diagnosis for High-Risk Breast Lesions Without Open Surgical Excision: The Intact Percutaneous Excision Trial (IPET)

Authors: Pat W. Whitworth, MD, Jean F. Simpson, MD, William R. Poller, MD, Steven M. Schonholz, MD, John F. Turner, MD, Rogsbert F. Phillips, MD, Joel M. Johnson, MD, F. David McEachin, MD

Published in: Annals of Surgical Oncology | Issue 11/2011

Abstract

Background

Open surgical excision (OSE) is generally recommended when image-guided core-needle breast biopsy demonstrates a high-risk lesion (HRL). We evaluated intact percutaneous excision (IPEX) with standard radiologic and histologic criteria for definitive diagnosis of HRL, particularly atypical ductal hyperplasia (ADH). The primary aim is to confirm criteria associated with <2% risk for upgrade to carcinoma, equivalent to risk associated with Breast Imaging Reporting and Data System (BI-RADS) 3 lesions, for which imaging surveillance is considered sufficient.

Methods

In a prospective trial, 1,170 patients recommended for breast biopsy at 25 institutions received IPEX with a vacuum- and radiofrequency-assisted device. ADH patients in whom the imaged lesion had been removed and the lesion adequately centered for definitive characterization were designated as the potential surgical avoidance population (PSAP) before OSE. Subsequent OSE specimen pathology was compared with IPEX findings.

Results

In 1,170 patients, 191 carcinomas and 83 (7%) HRL, including 32 ADH (3%), were diagnosed via IPEX. None of the 51 non-ADH HRL were upgraded to carcinoma on OSE (n = 24) or, if OSE was declined, on radiologic follow-up (n = 27). No ADH lesions meeting PSAP criteria (n = 10) were upgraded to carcinoma on OSE; 3 (14%) of 22 non-PSAP ADH lesions were upgraded to carcinoma on OSE. In summary, no upgrades to carcinoma were made in patients with non-ADH lesions who underwent IPEX or in ADH patients who had IPEX, met histologic and radiologic criteria, and underwent OSE or follow-up.

Conclusion

IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.

Silverstein MJ, Recht A, Lagios MD, et al. Special report: consensus conference III. Image-detected breast cancer: state-of-the-art diagnosis and treatment. J Am Coll Surg. 2009;209:504–20.PubMedCrossRef

Forgeard C, Benchaib M, Guerin N, et al. Is surgical biopsy mandatory in case of atypical ductal hyperplasia on 11-gauge core needle biopsy? A retrospective study of 300 patients. Am J Surg. 2008;196:339–45.PubMedCrossRef

Doren E, Hulvat M, Norton J, Rajan P, Sarker S, Aranha G, et al. Predicting cancer on excision of atypical ductal hyperplasia. Am J Surg. 2008;195:358–61; discussion 361–2.PubMedCrossRef

Hoang JK, Hill P, Cawson JN. Can mammographic findings help discriminate between atypical ductal hyperplasia and ductal carcinoma in situ after needle core biopsy? Breast. 2008;17:282–8.PubMedCrossRef

Allison KH, Eby PR, Kohr J, DeMartini WB, Lehman CD. Atypical ductal hyperplasia on vacuum-assisted breast biopsy: suspicion for ductal carcinoma in situ can stratify patients at high risk for upgrade. Hum Pathol. 2011;42:41–50.PubMedCrossRef

Kohr JR, Eby PR, Allison KH, DeMartini WB, Gutierrez RL, Peacock S, et al. Risk of upgrade of atypical ductal hyperplasia after stereotactic breast biopsy: effects of number of foci and complete removal of calcifications. Radiology. 2010;255:723–30. Epub Feb. 19, 2010.PubMedCrossRef

Albarracin CT, Nguyen CV, Whitman GJ, Weiang W, Sneige N. Identifying patients with atypical ductal hyperplasia diagnosed at core-needle biopsy who are at low risk of malignancy. Radiology. 2010;257:893–4; author reply 984.PubMedCrossRef

Nguyen CV, Albarracin CT, Whitman GJ, Lopez A, Sneige N. Atypical ductal hyperplasia in directional vacuum-assisted biopsy of breast microcalcifications: considerations for surgical excision. Ann Surg Oncol. 2011;18:752–61.PubMedCrossRef

Darling ML, Smith DN, Lester SC, et al. Atypical ductal hyperplasia and ductal carcinoma in situ as revealed by large-core needle breast biopsy: results of surgical excision. AJR Am J Roentgenol. 2000;175:1341–6.PubMed

10.

D’Orsi CJ, Mendelson EB, Ikeda DM, et al: Breast Imaging Reporting and Data System: ACR BI-RADS—breast imaging atlas. Reston, VA: American College of Radiology; 2003.

11.

Silverstein MJ, Lagios MD, Recht A, et al. Image-detected breast cancer: state of the art diagnosis and treatment. J Am Coll Surg. 2005;201:586–97.PubMedCrossRef

12.

Rogers LW. Breast biopsy: a pathologist’s perspective on biopsy acquisition techniques and devices with mammographic–pathologic correlation. Semin Breast Dis. 2005;8:127–37.CrossRef

13.

Sie A, Bryan DC, Gaines V, et al. Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device. Cancer. 2006;107:945–9.PubMedCrossRef

14.

Killebrew LK, Oneson RH. 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. 2006;12:302–8.PubMedCrossRef

15.

Smart CE, Furnival CM, Lakhani SR. High-risk lesions: ALH/LCIS/ADH. In: Kuerer HM, editor. Kuerer’s breast surgical oncology. New York, NY: McGraw-Hill; 2010. Chap 17, pp 179–87.

16.

Bruening W, Schoelles K, Treadwell J, Launders J, Fontanarosa J, Tipton K. Comparative effectiveness of core-needle and open surgical biopsy for the diagnosis of breast lesions. Comparative Effectiveness Review No. 19. Prepared by ECRI Institute Evidence-based Practice Center under Contract No. 290-02-0019. Rockville, MD: Agency for Healthcare Research and Quality. December 2009.

17.

Grady I, Gorsuch H, Wilburn-Bailey S. Ultrasound-guided, vacuum-assisted, percutaneous excision of breast lesions: an accurate technique in the diagnosis of atypical ductal hyperplasia. J Am Coll Surg. 2005;201:14–7.PubMedCrossRef

18.

Koskela AK, Sudan M, Berg MH, Kärjä VJ, Mustonen PK, Kataja V, et al. Add-on device for stereotactic core-needle breast biopsy: how many biopsy specimens are needed for a reliable diagnosis? Radiology. 2005;236:801–9.PubMedCrossRef

19.

Walker TM. Impalpable breast lesions: stereotactic core biopsy with an “add-on” unit. Breast. 1997;6:126–31.CrossRef

20.

Boarki K, Labib M. The role of US guided handheld vacuum assisted breast core biopsy (VACB) in the surgical management of breast nodules: preliminary report of KCCC experience. Gulf J Oncol. 2008 Jul;(4):39–44.

21.

March DE, Coughlin BF, Barham RB, et al. Breast masses: removal of all US evidence during biopsy by using a handheld vacuum-assisted device—initial experience. Radiology. 2003;227:549–55. Epub 2003 Apr 3.PubMedCrossRef

22.

Parker SH, Klaus AJ, McWey PJ, et al. Sonographically guided directional vacuum-assisted breast biopsy using a handheld device. AJR Am J Roentgenol. 2001;177:405–8.PubMed

23.

Chen SC, Yang HR, Hwang TL, Chen MF, Cheung YC, Hsueh S. Intraoperative ultrasonographically guided excisional biopsy or vacuum-assisted core needle biopsy for nonpalpable breast lesions. Ann Surg. 2003;238:738–42.PubMedCrossRef

24.

Johnson AT, Henry-Tillman RS, Smith LF, et al. Percutaneous excisional breast biopsy. Am J Surg. 2002;184:550–4; discussion 554.PubMedCrossRef

25.

Vargas HI, Vargas MP, Gonzalez K, Burla M, Khalkhali I. Percutaneous excisional biopsy of palpable breast masses under ultrasound visualization. Breast J. 2006;12(suppl 2):S218–22.PubMedCrossRef

26.

Fine RE, Boyd BA, Whitworth PW, Kim JA, Harness JK, Burak WE. Percutaneous removal of benign breast masses using a vacuum-assisted hand-held device with ultrasound guidance. Am J Surg. 2002;184:332–6.PubMedCrossRef

27.

Alonso-Bartolomé F, Vega-Bolívar A, Torres-Tabanera M, et al. Sonographically guided 11-G directional vacuum-assisted breast biopsy as an alternative to surgical excision: utility and cost study in probably benign lesions. Acta Radiol. 2004;45:390–6.PubMedCrossRef

28.

Allen SD, Nerurkar A, Della Rovere GU. The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? Eur Radiol. 2011;Jan 15. [Epub ahead of print].

Title: Definitive Diagnosis for High-Risk Breast Lesions Without Open Surgical Excision: The Intact Percutaneous Excision Trial (IPET)
Authors: Pat W. Whitworth, MD
Jean F. Simpson, MD
William R. Poller, MD
Steven M. Schonholz, MD
John F. Turner, MD
Rogsbert F. Phillips, MD
Joel M. Johnson, MD
F. David McEachin, MD
Publication date: 01-10-2011
Publisher: Springer-Verlag
Published in: Annals of Surgical Oncology / Issue 11/2011
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-011-1911-0

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Definitive Diagnosis for High-Risk Breast Lesions Without Open Surgical Excision: The Intact Percutaneous Excision Trial (IPET)

Abstract

Background

Methods

Results

Conclusion

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Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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