Schueller Gerd, Jaromi Sylvia, Ponhold Lothar, Fuchsjaeger Michael, Memarsadeghi Mazda, Rudas Margaretha, Weber Michael, Liberman Laura, Helbich Thomas H
Department of Radiology and Pathology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
Radiology. 2008 Aug;248(2):406-13. doi: 10.1148/radiol.2482071994.
To retrospectively determine the false-negative rate and the underestimation rate of ultrasonography (US)-guided 14-gauge core-needle breast biopsy (CNB) in nonpalpable lesions, with validation at surgical excision histologic examination and with stability during clinical and imaging follow-up.
Informed consent was waived by the institutional review board for this retrospective review of 1352 cases. In 1061 cases, patients underwent surgical excision of lesions visible at US subsequent to US-guided 14-gauge CNB. Follow-up of another 291 benign lesions at US-guided 14-gauge CNB histologic examination showed stability during clinical and imaging follow-up for at least 2 years. US and histologic findings were reviewed and compared for agreement. A false-negative finding was defined as pathologically proved cancer for which biopsy results were benign. The false-negative rate was defined as the proportion of all breast cancers with a diagnosis of benign disease at US-guided 14-gauge CNB. The underestimation rate was defined as an upgrade of a high-risk lesion at US-guided 14-gauge CNB to malignancy at surgery.
US 14-gauge CNB yielded 671 (63.2%) malignant, 86 (8.1%) high-risk, and 304 (28.7%) benign lesions. Each of the 291 benign lesions without surgery remained stable during follow-up. The agreement of US-guided 14-gauge CNB results, surgical excision findings, and follow-up results was 95.8% (kappa = 0.93). False-negative findings were encountered in 11 (0.8%) of 1352 cases, and the false-negative rate was 1.6% (11 of 671 malignancies). All false-negative findings were prospectively identified owing to discordance between imaging results and US-guided 14-gauge CNB histologic findings. The underestimation rate was 31.4%.
US-guided 14-gauge CNB is an alternative to surgical excision for assessing nonpalpable breast lesions.
回顾性确定超声（US）引导下14G粗针乳腺活检（CNB）对不可触及病变的假阴性率和低估率，并在手术切除组织学检查中进行验证，以及在临床和影像随访期间观察其稳定性。
机构审查委员会豁免了对1352例病例进行此项回顾性研究的知情同意。1061例患者在US引导下14G CNB后，对US可见的病变进行了手术切除。另外291例在US引导下14G CNB组织学检查为良性的病变，在临床和影像随访至少2年期间显示稳定。对US和组织学检查结果进行回顾并比较一致性。假阴性结果定义为病理证实为癌症但活检结果为良性的情况。假阴性率定义为在US引导下14G CNB诊断为良性疾病的所有乳腺癌的比例。低估率定义为在US引导下14G CNB时为高危病变但手术时升级为恶性病变的比例。
US引导下14G CNB检出671例（63.2%）恶性病变、86例（8.1%）高危病变和304例（28.7%）良性病变。291例未手术的良性病变在随访期间均保持稳定。US引导下14G CNB结果、手术切除结果和随访结果的一致性为95.8%（kappa = 0.93）。在1352例病例中有11例（0.8%）出现假阴性结果，假阴性率为1.6%（671例恶性病变中的11例）。所有假阴性结果均因影像结果与US引导下14G CNB组织学检查结果不一致而被前瞻性识别。低估率为31.4%。
US引导下14G CNB是评估不可触及乳腺病变的手术切除替代方法。
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