Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.
Ann Surg Oncol. 2011 Oct;18(11):3047-52. doi: 10.1245/s10434-011-1911-0. Epub 2011 Sep 27.
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.
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.
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.
IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.
当影像引导的核心针乳腺活检显示高危病变（HRL）时，通常建议进行开放式外科切除术（OSE）。我们评估了完整的经皮切除术（IPEX），并使用标准的影像学和组织学标准对 HRL 进行明确诊断，特别是非典型导管增生（ADH）。主要目的是确认与<2%的癌升级风险相关的标准，与乳腺影像报告和数据系统（BI-RADS）3 类病变相关的风险相当，对于这些病变，影像学监测被认为是足够的。
在一项前瞻性试验中，25 家机构推荐的 1170 名患者接受了真空和射频辅助设备的 IPEX。在 IPEX 中，对已切除影像学病变且病变充分居中以进行明确特征描述的 ADH 患者，在接受 OSE 之前被指定为潜在手术回避人群（PSAP）。随后对 OSE 标本的病理学进行了比较。
在 1170 名患者中，通过 IPEX 诊断出 191 例癌和 83 例（7%）HRL，包括 32 例 ADH（3%）。在 OSE 上，51 例非 ADH HRL 无一例升级为癌（n=24），或者如果拒绝 OSE，则在影像学随访上（n=27）无一例升级为癌。符合 PSAP 标准的 10 例 ADH 病变无一例在 OSE 上升级为癌；22 例非 PSAP ADH 病变中有 3 例（14%）在 OSE 上升级为癌。总之，在接受 IPEX 的非 ADH 病变患者或接受 IPEX、符合组织学和影像学标准并接受 OSE 或随访的 ADH 患者中，均未发现癌升级。
IPEX 结合明确的组织学和影像学标准以及影像学监测是对影像学检测到的 HRL，包括 ADH 的可接受的管理方法。
