自动化手持式乳腺超声与乳腺 X 线摄影对有症状门诊女性的诊断性能比较：中国多中心横断面研究。

The diagnostic performance of automated versus handheld breast ultrasound and mammography in symptomatic outpatient women: a multicenter, cross-sectional study in China.

机构信息

Department of Ultrasound, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.

Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.

出版信息

Eur Radiol. 2021 Feb;31(2):947-957. doi: 10.1007/s00330-020-07197-7. Epub 2020 Aug 27.

DOI:10.1007/s00330-020-07197-7

PMID:32852589

Abstract

OBJECTIVES

The purpose of this study was to evaluate the diagnostic performance of automated breast ultrasound (ABUS) for breast cancer by comparing it to handheld ultrasound (HHUS) and mammography (MG).

METHODS

A multicenter cross-sectional study was conducted between February 2016 and March 2017 in five tertiary hospitals in China, and 1922 women aged 30-69 years old were recruited. Women aged 30-39 years (group A) underwent ABUS and HHUS, and women aged 40-69 (group B) underwent additional MG. Images were interpreted using the Breast Imaging Reporting and Data System (BI-RADS). All BI-RADS 4 and 5 cases were confirmed pathologically. Sensitivities and specificities of all modalities were compared.

RESULTS

There were 83 cancers in 677 women in group A and 321 cancers in 1245 women in group B. In the whole study population, the sensitivities of ABUS and HHUS were 92.8% (375/404) and 96.3% (389/404), and the specificities were 93.0% (1411/1518) and 89.6% (1360/1518), respectively. ABUS had a significantly higher specificity to HHUS (p < 0.01), while HHUS had higher sensitivity (p = 0.01). In group B, the sensitivities of ABUS, HHUS, and MG were 93.5% (300/321), 96.6% (310/321), and 87.9% (282/321). The specificities were 93.0% (859/924), 89.9% (831/924), and 91.6% (846/924). ABUS had significantly higher sensitivity (p = 0.02) and comparable specificity compared with MG (p = 0.14).

CONCLUSION

ABUS increased sensitivity and had similar specificity compared with mammography in the diagnosis of breast cancer. Additionally, ABUS has comparable performance to HHUS in women aged 30-69 years old. ABUS or HHUS is a suitable modality for breast cancer diagnosis.

KEY POINTS

• In breast cancer diagnosis settings, automated breast ultrasound has a higher cancer detection rate, sensitivity, and specificity than mammography, especially in women with dense breasts. • Compared with handheld ultrasound, automated breast ultrasound has higher specificity, lower sensitivity, and comparable diagnostic performance. • Automated breast ultrasound is a suitable modality for breast cancer diagnosis, and may have a potential indication for its further use in the breast cancer early detection.

摘要

目的

本研究旨在通过比较自动乳腺超声（ABUS）与手持超声（HHUS）和乳腺 X 线摄影（MG），评估 ABUS 对乳腺癌的诊断性能。

方法

这是一项 2016 年 2 月至 2017 年 3 月在中国五家三级医院进行的多中心横断面研究，共纳入 1922 名 30-69 岁女性。30-39 岁女性（A 组）接受 ABUS 和 HHUS 检查，40-69 岁女性（B 组）加做 MG 检查。采用乳腺影像报告和数据系统（BI-RADS）进行图像解读。所有 BI-RADS 4 级和 5 级病例均经病理证实。比较了所有方法的敏感度和特异度。

结果

A 组中 677 名女性中有 83 例癌症，B 组中 1245 名女性中有 321 例癌症。在整个研究人群中，ABUS 和 HHUS 的敏感度分别为 92.8%（375/404）和 96.3%（389/404），特异度分别为 93.0%（1411/1518）和 89.6%（1360/1518）。ABUS 的特异度明显高于 HHUS（p＜0.01），而 HHUS 的敏感度较高（p=0.01）。B 组中，ABUS、HHUS 和 MG 的敏感度分别为 93.5%（300/321）、96.6%（310/321）和 87.9%（282/321）。特异度分别为 93.0%（859/924）、89.9%（831/924）和 91.6%（846/924）。ABUS 的敏感度明显高于 MG（p=0.02），与 MG 的特异度相当（p=0.14）。