Diagnostic accuracy of stereotactic large‐core needle biopsy for nonpalpable breast disease: Results of a multicenter prospective study with 95% surgical confirmation

Abstract

Stereotactic large-core needle biopsy is increasingly applied for the diagnosis of nonpalpable breast disease. Our study examines whether this minimally invasive technique is sufficiently accurate to replace surgical breast biopsy. In a prospective multicenter study, 973 consecutive women with 1,029 nonpalpable breast lesions were offered stereotactic 14-gauge needle biopsy. If the needle biopsy yielded breast cancer, the patient was offered therapeutic surgery. Surgical biopsy was proposed in cases of needle biopsies without malignancy. An expert panel reviewed all discrepancies in histologic diagnosis between the needle biopsy and open biopsy. Forty-five patients withdrew from participation and 113 (11%) planned needle biopsy procedures were cancelled. Of the 871 successful biopsy procedures, 95% were confirmed surgically. In 13 cases (1.5%), insufficient material was obtained for histologic assessment. Fifty-five percent of the needle biopsies were diagnosed as malignant (290 invasive cancers, 190 ductal carcinoma in situ). Thirteen of the 322 lesions (4%, 95% CI 2-7%) with a benign needle biopsy diagnosis contained malignancy after surgery. Six of the 26 (23%, 95% CI 9 -44%) lesions with a high-risk diagnosis (atypical ductal or lobular hyperplasia or lobular carcinoma in situ) were diagnosed as malignant after surgery. Five of the 30 lesions containing normal breast tissue held malignancy (17%, 95% CI 6 -35%). Guidelines for the management of different categories of needle biopsy diagnoses were made. Application of these guidelines to the present findings resulted in sensitivity and specificity rates of 97% (95% CI 95-98%) and 99% (95% CI 97-100%), respectively. Stereotactic large-core needle biopsy is an accurate diagnostic instrument for nonpalpable breast disease. It may safely replace needle localised open-breast biopsy provided that high-risk and normal breast tissue diagnoses are followed by needle or openbreast biopsy.

Stereotactic Large Core Needle Biopsy for All Nonpalpable Breast Lesions?

“…In each patient, SLCNB was followed by surgical excision (wire localised excision biopsy for nonmalignant lesions, breast conserving treatment or mastectomy for malignant lesions) to compare the initial diagnosis with that of the gold standard. The sensitivity and specificity of the new technique were 97 and 99%, respectively, and thus are comparable to surgical biopsy [11][12][13].…”

“…The methods and results of this study are described elsewhere [11]. For the purpose of the present study we categorised the patients in two groups: one group referred by the national screening program ('screening', n = 511 lesions) and one consisting of patients with a specific motive for mammographic surveillance ('non-screening', n = 339 lesions).…”

“…However, in the last decade, various minimally invasive diagnostic procedures have been developed [8][9][10]. Recently, we have tested the stereotactic large core needle biopsy (SLCNB) in a Dutch prospective multicenter trial, the COBRA study (COre Biopsy after RAdiological localisation) [11]. In a group of 972 consecutive women with 1029 nonpalpable mammographic abnormalities SLCNB was performed to determine the histological diagnosis.…”

Minimally Invasive Approaches for Diagnosis and Treatment of Early-Stage Breast Cancer

“…Diagnostic accuracy of large-core needle biopsy is high: miss rates of cancer vary from 1% to 7%, whereas falsepositive findings are extremely rare [12,13]. However, in some cases, the severity of the disease is underestimated (i.e., when findings at subsequent surgical excision show a higher degree of pathology than do core biopsy results).…”

“…As a result, the majority of patients with benign lesions are spared diagnostic open surgery. Complications are rare (Ͻ2%) and include hematomas, persistent bleeding, vasovagal episodes, and wound infection [12,13].…”