American College of Radiology Imaging Network, Philadelphia, Pa, USA.
Radiology. 2013 Sep;268(3):673-83. doi: 10.1148/radiol.13122251. Epub 2013 Apr 24.
To determine prospectively the prevalence and rate of malignancy of multiple bilateral (MB) circumscribed breast masses detected at screening ultrasonography (US) compared with those of other US-depicted masses.
This institutional review board-approved, HIPAA-compliant prospective trial included women at elevated risk for breast cancer, who gave written informed consent to participate in a study evaluating cancer detection rates for three rounds of annual supplemental screening US at 21 international sites. After exclusions, 2662 participants and 7473 screening studies were included. Physician-performed US studies were interpreted, with blinding to mammography results. Simple cysts were noted. Breast Imaging Reporting and Data System features of all other findings were recorded, with addition of the descriptor MB similar-appearing circumscribed masses (minimum of three total and at least one in each breast), with details of the largest such mass recorded. Rates of malignancy were determined after biopsy or mammographic and US follow-up at a minimum of 11 months. For this analysis, 490 women (1370 screenings) with prior mastectomy were excluded. Descriptive statistics and exact 95% confidence intervals (CIs) were generated.
Of 2172 evaluable participants (6103 screening studies; median age at study entry, 54.0 years; range, 25-91 years), 1454 had unique findings at US. One hundred thirty-five (6.2%) participants had 153 unique MB circumscribed masses, with no malignancies (0% [95% CI: 0%, 2.4%]; 95% CI: 0%, 2.9% for the 127 masses with at least 2 years of follow-up). There were 1319 (60.7%) participants with 2464 non-MB lesions, including 1038 solitary circumscribed masses with a malignancy rate of 0.8% (eight of 1038). Of 836 solitary circumscribed masses with at least 2 years of follow-up, the malignancy rate was 0.4% (three of 836; 95% CI: 0.1%, 1.0%). Of the 135 women with MB circumscribed masses, 82 (60.7%) also had a solitary lesion. Two of these 82 women (2.4%) had cancer.
MB similar-appearing circumscribed masses seen at screening US are almost always benign, with no malignancies found among such lesions in this prospective, multicenter experience. These lesions are suitable for diagnostic follow-up in 1 year, with resumption of screening thereafter if they are stable.
前瞻性地确定在筛查超声（US）中检测到的多发性双侧（MB）局限性乳腺肿块的患病率和恶性肿瘤发生率，与其他 US 显示的肿块相比。
本研究经机构审查委员会批准，并符合 HIPAA 规定，纳入了乳腺癌风险升高的女性，她们书面同意参加一项研究，评估在 21 个国际地点进行的三轮年度补充筛查 US 的癌症检出率。排除后，纳入 2662 名参与者和 7473 项筛查研究。由医师进行 US 检查，并对 mammography 结果进行盲法解读。记录单纯囊肿。记录所有其他发现的乳腺影像报告和数据系统特征，并添加 MB 类似表现的局限性肿块（至少有三个，且每个乳房至少有一个）的描述符，记录最大肿块的详细信息。在至少 11 个月的时间内通过活检或 mammographic 和 US 随访来确定恶性肿瘤发生率。在这项分析中，排除了 490 名（1370 次筛查）先前接受过乳房切除术的女性。生成了描述性统计数据和精确的 95%置信区间（CI）。
在 2172 名可评估参与者（6103 次筛查；中位入组年龄为 54.0 岁；范围为 25-91 岁）中，1454 名参与者在 US 检查中有独特的发现。135 名参与者（6.2%）有 153 个独特的 MB 局限性肿块，无恶性肿瘤（0%[95%CI：0%，2.4%]；在 127 个至少随访 2 年的肿块中，95%CI 为 0%，2.9%）。1319 名参与者（60.7%）有 2464 个非 MB 病变，包括 1038 个孤立性局限性肿块，恶性肿瘤发生率为 0.8%（8/1038）。在 836 个至少随访 2 年的孤立性局限性肿块中，恶性肿瘤发生率为 0.4%（3/836；95%CI：0.1%，1.0%）。在 135 名有 MB 局限性肿块的女性中，82 名（60.7%）还存在孤立性病变。这 82 名女性中有 2 名（2.4%）患有癌症。
在筛查 US 中观察到的多发性双侧（MB）类似表现的局限性肿块几乎总是良性的，在这项前瞻性、多中心研究中未发现此类病变中有恶性肿瘤。这些病变适合在 1 年内进行诊断性随访，如果稳定，可在此后恢复筛查。
