一项基于多中心医院的关于自动乳腺超声系统在中国女性中检测乳腺癌的诊断研究。
A multicenter hospital-based diagnosis study of automated breast ultrasound system in detecting breast cancer among Chinese women.
作者信息
Zhang Xi, Lin Xi, Tan Yanjuan, Zhu Ying, Wang Hui, Feng Ruimei, Tang Guoxue, Zhou Xiang, Li Anhua, Qiao Youlin
机构信息
Department of Epidemiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Ultrasound, State Key Laboratory of Oncology in Southern China, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
出版信息
Chin J Cancer Res. 2018 Apr;30(2):231-239. doi: 10.21147/j.issn.1000-9604.2018.02.06.
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.
目的
自动乳腺超声系统（ABUS）是一种用于乳腺癌检测的潜在方法；然而，其诊断性能仍不明确。我们开展了一项基于医院的多中心诊断研究，通过将ABUS与手持超声（HHUS）和乳腺X线摄影（MG）进行比较，以评估ABUS在乳腺癌检测中的临床性能。
方法
符合条件的参与者接受HHUS和ABUS检测；40 - 69岁的女性还接受MG检测。使用乳腺影像报告和数据系统（BI-RADS）对图像进行解读。BI-RADS分类为1 - 2类的女性被视为阴性。分类为BI-RADS 3类的女性接受磁共振成像以区分真阴性和假阴性结果。对分类为BI-RADS 4 - 5类的女性进行核心穿刺活检或手术活检，随后进行病理诊断。计算ABUS、HHUS和MG之间的Kappa值和一致率。
结果
共有1973名女性纳入最终分析。其中，1353名（68.6%）和620名（31.4%）分别被分类为BI-RADS 1 - 3类和4 - 5类。在年龄较大的组中，ABUS与HHUS之间的一致率和Kappa值分别为94.0%和0.860（P<0.001）；ABUS与MG之间的一致率和Kappa值分别为89.2%和0.735（P<0.001）。关于影像与病理结果的一致性，基于ABUS分类为BI-RADS 4 - 5类的女性中，78.6%被诊断为癌前病变或癌症；这比基于HHUS的女性高7.2%。对于BI-RADS 1 - 2类，ABUS和HHUS的假阴性率几乎相同，且远低于MG。
结论
我们观察到ABUS具有良好的诊断可靠性。考虑到其在高密度乳腺女性乳腺癌检测中的性能以及较低的操作者依赖性，ABUS在中国是一种有前景的乳腺癌检测选择。
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