Verkooijen Helena M
Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Int J Cancer. 2002 Jun 20;99(6):853-9. doi: 10.1002/ijc.10419.
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 open-breast biopsy.
立体定向大芯针活检越来越多地应用于不可触及乳腺疾病的诊断。我们的研究旨在探讨这种微创技术是否足够准确，足以取代手术乳腺活检。在一项前瞻性多中心研究中，为973例连续的患有1029个不可触及乳腺病变的女性提供了立体定向14号针活检。如果针吸活检确诊为乳腺癌，则为患者提供治疗性手术。针吸活检未发现恶性肿瘤的病例建议进行手术活检。一个专家小组审查了针吸活检和开放活检之间组织学诊断的所有差异。45名患者退出研究，113例（11%）计划的针吸活检程序被取消。在871例成功的活检程序中，95%经手术证实。13例（1.5%）获取的组织材料不足以进行组织学评估。55%的针吸活检被诊断为恶性（290例浸润性癌，190例原位导管癌）。针吸活检诊断为良性的322个病变中，有13个（4%，95%可信区间2 - 7%）在手术后发现含有恶性肿瘤。高危诊断（非典型导管或小叶增生或小叶原位癌）的26个病变中有6个（23%，95%可信区间9 - 44%）在手术后被诊断为恶性。30个含有正常乳腺组织的病变中有5个（17%，95%可信区间6 - 35%）存在恶性肿瘤。制定了不同类别针吸活检诊断的管理指南。将这些指南应用于本研究结果，敏感性和特异性分别为97%（95%可信区间95 - 98%）和99%（95%可信区间97 - 100%）。立体定向大芯针活检是不可触及乳腺疾病的一种准确诊断工具。如果对高危和正常乳腺组织的诊断之后进行针吸活检或开放乳腺活检，它可以安全地取代针定位开放乳腺活检。
