Abstract
This study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria were invited for breast examination by HHUS, ABUS or/and mammography. For BI-RADS category 3, an additional magnetic resonance imaging (MRI) test was provided to distinguish the true negative results from false negative results. For women classified as BI-RADS category 4 or 5, either core aspiration biopsy or surgical biopsy was done to confirm the diagnosis. Between February 2016 and March 2017, 2844 women signed the informed consent form, and 1947 of them involved in final analysis (680 were 30 to 39 years old, 1267 were 40 to 69 years old).For all participants, ABUS sensitivity (91.81%) compared with HHUS sensitivity (94.70%) with non-inferior Z tests, P = 0.015. In the 40–69 age group, non-inferior Z tests showed that ABUS sensitivity (93.01%) was non-inferior to MG sensitivity (86.02%) with P < 0.001 and HHUS sensitivity (95.44%) was non-inferior to MG sensitivity (86.02%) with P < 0.001. Sensitivity of ABUS and HHUS are all superior to that of MG with P < 0.001 by superior test.For all participants, ABUS specificity (92.89%) was non-inferior to HHUS specificity (89.36%) with P < 0.001. Superiority test show that specificity of ABUS was superior to that of HHUS with P < 0.001. In the 40–69 age group, ABUS specificity (92.86%) was non-inferior to MG specificity (91.68%) with P < 0.001 and HHUS specificity (89.55%) was non-inferior to MG specificity (91.68%) with P < 0.001. ABUS is not superior to MG with P = 0.114 by superior test. The sensitivity of ABUS/HHUS is superior to that of MG. The specificity of ABUS/HHUS is non-inferior to that of MG. In China, for an experienced US radiologist, both HHUS and ABUS have better diagnostic efficacy than MG in symptomatic individuals.
Highlights
Breast cancer is the most common cancer in women worldwide1
Breast density was reassessed by the radiologist and classified by using Breast Imaging Reporting and Data System (BI-RADS) density category 1 (“almost entirely fat”), category 2 (“scattered fibroglandular densities”), category 3 (“heterogeneously dense”), or category 4 (“extremely dense”).” 24.31% of women were classified as having BI-RADS breast density type1-2, 75.69% type [3,4] by radiologists (Table 1)
Superiority Mcnemar test was not available. This multicenter study demonstrated that ultrasound (ABUS or US) is superior to mammography in dense breast patients, but perform as good as X-rays in low-dense breast patients
Summary
Breast cancer is the most common cancer in women worldwide. Over half of all cases (53.0%) occur in less developed regions of the w orld[1,2]. It is crucial to conduct an evidence-based study for the effectiveness of ultrasound techniques for the detection of breast cancer in the female population in China. Handheld ultrasound (HHUS) can be used to screen the whole breast, the technique is timeconsuming and is less likely to achieve a standardized image because of the mobility of the breast tissue and the high degree of operator-dependence. This has become a major obstacle to the acceptance of ultrasound as a breast cancer screening technology in poor areas of developing and middle-income countries. Our goal was to compare ABUS, X-ray and HHUS and to determine if ABUS could be a suitable methodology for breast cancer screening
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