A substantial proportion of cancers that were missed in a screening program, despite double reading, were found with this detection method at less than one false-positive finding per image.

Purpose: To outline the current status of and provide insight into possible future research on the breast lesion excision system (BLES) as a diagnostic and therapeutic device. Methods: A systematic search of the literature was performed using PubMed, Embase, and the Cochrane databases to identify relevant studies published between January 2002 and April 2018. Studies were considered eligible for inclusion if they evaluated the diagnostic or therapeutic accuracy or safety of BLES. Results: Ultimately, 17 articles were included. The reported underestimation rates of atypical ductal hyperplasia and ductal carcinoma in situ (DCIS) ranged from 0 to 14.3% and from 0 to 22.2%, respectively. Complete excision rates for invasive ductal carcinoma and DCIS ranged from 5.3 to 76.3%. Bleeding was the most frequently reported complication (0-11.8%). Device-related complications may arise, with an empty basket being the most common (0.6-3.6%). Thermal damage of the specimen, caused by the use of a radiofrequency cutting wire, was reported in eight of the included studies. Most thermal artifacts were reported as superficial and small (0.1-1.9 mm). Conclusions: The BLES, an automated, image-guided, single-pass biopsy system for breast lesions using radiofrequency is designed to excise and retrieve an intact tissue specimen. It is an efficient and safe breast biopsy method with acceptable complication rates, which may be used as an alternative to vacuum-assisted biopsies. The variable rate of complete excision raises questions about the possibility to use BLES as a therapeutic device for the excision of small lesions. Further research should focus on this aspect of BLES.

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Background: Screening guidelines for women with a family history of breast cancer without a known causative gene mutation differ per country. No randomized controlled trial has been performed to assess the optimal screening strategy for these women. Methods: In twelve centers, 1355 women aged 30–55 years with a cumulative lifetime risk of ≥20% without a BRCA1/2 mutation were randomized into two arms. From January 2011 until December 2017, women in the MRI-arm received yearly MRI-screening, clinical breast examination (CBE), and mammography every other year; and in the Mx-arm yearly mammography and CBE. Outcomes were number and stage of detected breast cancers, sensitivity, specificity and positive predictive value, and stratified by screening round and by mammographic density. Results: After on average 4.3 screening rounds per woman, in the MRI-arm (N=675) compared to the Mx-arm (N=680) more breast cancers were detected (41 versus 14, p<0.001), invasive cancers were smaller (median size 8 versus 17 mm, p=0.006) and less often node positive (20% versus 71.4%, p=0.019)(Table). In the MRI-arm, sensitivity was slightly higher (95.1% versus 92.9%, p=1), and specificity significantly lower (82% versus 90.1%, p<0.001), compared to the Mx-arm. After two rounds, specificity improved for both modalities (87.1% for MRI; 93.0% for Mx; p<0.001) and no ≥T2 tumors or interval cancers occurred in the MRI-arm. All tumors ≥T2 were in the two highest density categories. MRI detected more small invasive tumors than Mx across all density categories. Conclusions: In real-life practice the MRI-arm detected more, relevantly smaller, and far more often node negative tumors, and also at low density in women with a familial risk for breast cancer. Table 1Characteristics of participating women at baseline and of the detected breast cancers, according to study armParticipantsMRI-arm n=675Mx-arm n=680MRI-arm vs. Mx-arm p-valueMean age yr ± SD44.6 ± 6.244.7 ± 6.3 Premenopausal512 (76%)505 (74%) Previous Mx ≤ 2 yr536 (79 %)542 (80%) Previous Mx > 2 years ago23 ( 3%)29 ( 4%) Previous MRI ≤ 2 years ago62 ( 9%)81 (12%) Previous MRI > 2 years ago91 (14%)89 (13%) BI-RADS density category*   I (entirely fat)88 (13%)92 (14%) II (scattered densities)248 (37%)229 (34%) III (heterogeneously dense)238 (35%)243 (36%) IV (extremely dense)98 (15%)102 (15%) Mean age at cancer detection49,6 ± 7.049,8 ± 4,70.74No cancer – no. (%)634 (94%)666 (98%) Invasive breast cancers – no. (%)25 (4%)7 (1%)<0.001 (noBC/inv BC/DCIS)DCIS – no. (%)16 (2%)7 (1%) Median size of invasive cancers8 mm17 mm0.006T1a/b15 (60%)1 (14%) T1c7 (28%)4 (57%)0.078 (T1a-b/T1c/≥ T2)≥ T23 (12%)2 (29%) Node pos5 (20%)5 (71%)0.019 (N+/-)Node negative20 (80%)2 (29%) DCIS grade 15 (31%)2 (29%) DCIS grade 28 (50%)4 (57%)1 (dcis gr1,2,3)DCIS grade 33 (19%)1 (14%) *Determined by radiologists, according to the fourth ACR BI-RADS edition Citation Format: Tilanus-Linthorst MM, Saadatmand S, Geuzinge AH, Rutgers EJ, Mann R, de Roy van Zuidewijn DB, Zonderland HM, Tollenaar RA, Lobbes MB, Ausems MG, van 't Riet M, Hooning MJ, Mares-Engelbert I, Luiten EJ, Heijnsdijk EA, Verhoef C, Karssemeijer N, Oosterwijk JC, Obdeijn I-M, de Koning HJ. MRI breast cancer screening compared to mammography in women with a familial risk: A multicenter randomized controlled trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-13-01.