Background: Imaging-guided breast biopsy is crucial for breast lesion evaluation. We aim to make the first comprehensive comparison of two different ultrasound-guided breast biopsy devices: 14-G conventional core needle biopsy (CCNB) and the newly applied cable-free, low-vacuum-assisted 10-G breast biopsy system, Elite.
Methods: We retrospectively collected patients with suspected breast cancer who underwent ultrasound-guided 14-G CCNB or 10-G Elite from October 2013 through March 2018 and compared the biopsy result with the result after operation. We analyzed the test performance of the two methods and their accuracy in immunohistochemistry assays mainly including estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, and Ki67. We also analyzed the accuracy of 10-G Elite with frozen sections.
Results: Six hundred seventy-four patients who underwent 14-G CCNB and 592 patients who underwent 10-G Elite were finally included in the research. Negative predictive value with Elite was higher than with CCNB (Elite 86.5%, CCNB 41.7%, P < 0.001). Sensitivity (Elite 97.7%, CCNB 96.2%, P = 0.1), specificity (Elite 98.7%, CCNB 90.0%, P = 0.1), positive predictive value (Elite 99.8%, CCNB 99.7%, P = 0.7), and false negative rate (Elite 2.3%, CCNB 3.8%, P = 0.1) showed no difference between two devices. In terms of immunohistochemistry assay, Ki67 agreement of Elite was higher than that of CCNB (Elite 79.5%, CCNB 73.4%, P = 0.045). Estrogen receptor agreement (Elite 90.6%, CCNB 87.7%, P = 0.2), progesterone receptor agreement (Elite 83.9%, CCNB 80.9%, P = 0.3), and human epidermal growth factor receptor two agreement (Elite 94.2%, CCNB 93.5%, P = 0.7) showed no difference between Elite and CCNB. The rate of an inconclusive biopsy result was lower with Elite than with CCNB (Elite 1.5%, CCNB 3.3%, P = 0.045).
Conclusions: 10-G Elite has higher negative predictive value, higher Ki67 agreement, and lower inconclusive results than 14-G CCNB. Elite can be a reliable substitute for 14-G CCNB.
Keywords: Breast cancer; Core needle biopsy; Immunohistochemistry (IHC) assay; Vacuum-assisted biopsy.
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