title: Definitive diagnosis for high-risk breast lesions without open surgical excision: the Intact Percutaneous Excision Trial (IPET).
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.
  
  
  CONCLUSIONS
  IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.
authors.affiliation: Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA. patwhitworth@gmail.com
authors.forename: Pat W
authors.initials: PW
authors.lastname: Whitworth
authors.forename: Jean F
authors.initials: JF
authors.lastname: Simpson
authors.forename: William R
authors.initials: WR
authors.lastname: Poller
authors.forename: Steven M
authors.initials: SM
authors.lastname: Schonholz
authors.forename: John F
authors.initials: JF
authors.lastname: Turner
authors.forename: Rogsbert F
authors.initials: RF
authors.lastname: Phillips
authors.forename: Joel M
authors.initials: JM
authors.lastname: Johnson
authors.forename: F David
authors.initials: FD
authors.lastname: McEachin
mesh_terms: D001707:Biopsy, Needle / Q000295:instrumentation*; D001943:Breast Neoplasms / Q000175:diagnosis*; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000175:diagnosis*; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000175:diagnosis*; D010212:Papilloma / Q000175:diagnosis*; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D014618:Vacuum