Minimally Invasive Intact Excision of High-Risk Breast Lesions and Small Breast Cancers: The Intact Percutaneous Excision (IPEX) Registry
Aiming to minimize overtreatment of high-risk breast lesions (HRLs), including atypical ductal hyperplasia, and small breast cancers, including ductal carcinoma in situ (DCIS), we investigated a minimally invasive (MI) approach to definitive diagnosis and management of these conditions.
In the prospective Intact Percutaneous Excision registry study, women aged 31–86 years had removal of small invasive cancers, DCIS, or HRLs using image-guided 12–20 mm radiofrequency basket capture (MI excision). Second-pass 20 mm basket capture obtained shaved margins in cancer patients. Standard imaging (specimen, breast) and histologic criteria were applied. Patient data were registered in an Institutional Review Board approved, Health Insurance Portability and Accountability Act-compliant registry.
Of 282 registered patients, 124 had DCIS (n = 52) or invasive cancer (n = 72) and 160 had HRLs. Among cancer patients, 101 (81%) had clear histologic margins [average lesion size was 11 mm for both invasive cancers (4–20 mm) and DCIS (1.5–20 mm)]; 29 patients had re-excision (six despite clear margins). Among 160 HRLs, two were upgraded to DCIS and had MI excision. Two other HRL patients had subsequent standard surgical excision (no cancer found).
For diminutive HRLs, DCIS, and invasive cancers, MI excision can achieve the same procedure goals as standard surgical excision. Because MI excision removes less tissue with small incisions, it may reduce the discomfort and expense associated with standard treatment.
This work was supported by an unrestricted research grant from Intact Medical Corporation, Framingham, MA, USA.
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