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文摘
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Objective: The automated breast ultrasound system (ABUS) is a potential method for breast cancer detection; however, its diagnostic performance remains unclear. We conducted a hospital-based multicenter diagnostic study to evaluate the clinical performance of the ABUS for breast cancer detection by comparing it to handheld ultrasound (HHUS) and mammography (MG). Methods: Eligible participants underwent HHUS and ABUS testing; women aged 40–69 years additionally underwent MG. Images were interpreted using the Breast Imaging Reporting and Data System (BI-RADS). Women in the BI-RADS categories 1–2 were considered negative. Women classified as BI-RADS 3 underwent magnetic resonance imaging to distinguish true- and false-negative results. Core aspiration or surgical biopsy was performed in women classified as BI-RADS 4–5, followed by a pathological diagnosis. Kappa values and agreement rates were calculated between ABUS, HHUS and MG. Results: A total of 1,973 women were included in the final analysis. Of these, 1,353 (68.6%) and 620 (31.4%) were classified as BI-RADS categories 1–3 and 4–5, respectively. In the older age group, the agreement rate and Kappa value between the ABUS and HHUS were 94.0% and 0.860 (P<0.001), respectively; they were 89.2% and 0.735 (P<0.001) between the ABUS and MG, respectively. Regarding consistency between imaging and pathology results, 78.6% of women classified as BI-RADS 4–5 based on the ABUS were diagnosed with precancerous lesions or cancer; which was 7.2% higher than that of women based on HHUS. For BI-RADS 1–2, the false-negative rates of the ABUS and HHUS were almost identical and were much lower than those of MG. Conclusions: We observed a good diagnostic reliability for the ABUS. Considering its performance for breast cancer detection in women with high-density breasts and its lower operator dependence, the ABUS is a promising option for breast cancer detection in China. |
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地址
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Department of Epidemiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021
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Department of Ultrasound, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Guangzhou, 510060
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Department of Ultrasound, the First People's Hospital of Hangzhou, Affiliated Hangzhou Hospital of Nanjing Medical University, Hangzhou, 310006
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Department of Breast Imaging, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060
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Department of Ultrasound, Xin Hua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092
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Department of Cancer Prevention Research, Sun Yat-Sen University Cancer Center, Guangzhou, 510060
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Department of Interventional Radiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021
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