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6/7/2017 Disclosure Comparison of Digital Breast Research grant : GE Electronic Tomosynthesis and Ultrasound in Diagnosis of Breast Cancer: A Prospective Performance Study Jung Min Chang Seoul National University Hospital Contents


  1. 6/7/2017 Disclosure Comparison of Digital Breast • Research grant : GE Electronic Tomosynthesis and Ultrasound in Diagnosis of Breast Cancer: A Prospective Performance Study Jung Min Chang Seoul National University Hospital Contents Screening Mammography • MG remains mainstay of imaging modality • Conventional MG in dense breasts has known • Screening Mammography in dense breasts limitations • Diagnostic performance of screening breast – Early studies showed sensitivity decreasing to US 30% to 48% in dense breasts compared with • Diagnostic performance of DBT 80% to 98% in fatty breasts • Results of comparison studies of DBT vs. US – More recent study showing 57.1% sensitivity in dense breasts and up to 92.7% in fatty breasts • 20%-30% of breast cancers not detected in MG 1

  2. 6/7/2017 Dense Breast Issue • Tumors obscured by superimposed breast tissue • Imperfect sensitivity of MG has led to the use of adjunctive imaging, including US, DBT, MRI • In a study of 335 screening US–detected cancers, 81% (272 out of 335) were not seen at MG, even in retrospect * * Bae MS et al. Radiology 2014 F/37 IDC F/46 IDC F/47 IDC F/49 DCIS Screening Whole Breast US • Well tolerated by patients • Performance Whole Breast US – Supplemental CDR: 3-4/1000 • Incidence vs. Prevalence, patient characteristics – Using advanced technology s/a Doppler, Elastography – Better characterization for lesion in the breast 2

  3. 6/7/2017 F/47, screening IDC, GR 2, HR+ CDR, Recall and PPV of J-Start MG vs. MG+US screening Japan Strategic Anti-cancer Randomized Trial in women aged 40-49 years (J-START) • 2007-2011 • 72,998 asymptomatic women, ages 40-49y Intervention group Control group • 2 screening rounds/ 2 years (n=36,752) (n=35,965) • Intervention group CDR 184 (5/1000) 117 (3.2/1000) Recall 4647(12.6%) 3153 (8.8%) – MG + HH WBUS Biopsy 1665 (4.5%) 655 (1.8%) – n = 36,752 Interval cancer 18 (0.05%) 35 (0.10%) • Control group More frequently clinical stage 0 & I in the intervention group than in the control – MG only group (144 [71·3%] vs 79 [52·0%], p=0·0194). – n = 35,965 Ohuchi N, et al. Lancet 2016 Ohuchi N, et al. Lancet 2016 3

  4. 6/7/2017 Breast Cancers Detected at Characteristics of screening Screening US: Survival Rates US-detected cancers • Screening US-detected cancers* � 501 women (median age, 47; 425 invasive) – Small invasive cancer without lymph node � Stage 0 (15.2%), I (70.3%), II (13%) and III (1.6%). metastasis � No deaths but 15 (3.0%) recurrences confined to – Luminal A subtype >> HER-2 subtype the ipsilateral or contralateral breast at a median – BI-RADS assessment category 4A follow-up of 7 years (range, 5-12 yr). � The 5-year survival and recurrence-free survival (RFS) was 100% and 98% (96.8-99.2%). Kim SY, et al. Radiology 2017 * Bae MS, et al. Cancer Sci 2011 Oct Annual Screening US to MG Screening with Handheld US • Increased cancer detection rate sustainable? CDR MG alone MG+US Diff (per (MG+US vs. MG) 1000) No./ Estimate No./ Estimate Estimate P value Total of (95% CI) Total of (95% CI) (95% CI) Widely available � Operator dependency Women Women � Low cost (portable) � High false positive rate 20/2659 7.5 34/2659 12.8 5.3 <.001 Screen 1 � (4.6-11.6) (8.9-17.8) (2.1-8.4) No radiation � Standardization � 39/4814 8.1 57/4814 11.8 3.7 <.001 Screen 2,3 (5.8-11.1) (9.0-15.3) (2.1-5.8) No compression � Time-consuming � In elevated breast cancer risk Berg et al. JAMA 2012 4

  5. 6/7/2017 ABUS screening • Reproducible, Diminished operator dependence • Better demonstration of the breast anatomy and Digital Breast documenting the lesion orientation Tomosynthesis • CAD detection and diagnosis of breast lesions • Time-efficient for radiologists • Additional 3.6 cancers per 1000 women screened when ABUS was added to mammography in dense breasts or high risk * • Additional 1.9 cancers per 1000 women screened in dense breast women ** * Kelly et al. European Radiology 2010 ** Brem et al. Radiology 2015 Digital Breast Tomosynthesis Supplemental role of DBT • Emerging technique, allows the breasts to be • Widely used viewed in 3D information reducing superimposition • Additional cancer detection by using DBT after of breast tissue negative mammography: 1- 2.7 / 1000 screens • Requires the same equipment as two-dimensional • Decreased recall rate in the range of 1.6 - 4.5 % (2D) MG, with only a few additional seconds required for single-view acquisition. 5

  6. 6/7/2017 Comparison of Digital Mammography Breast cancer screening with DBT Alone and Digital Mammography Plus Tomosynthesis in a Population-based • Larger multicenter study on breast cancer screening Screening Program using DBT in combination with DM. • About 500,000 patients • 12,631 women (2010.11-2011.12) • Largest volume study reflecting all diversity of practice • DM+DBT DM (n=281,187) Cancer detection rate • RR for additional imaging (n=173,663) (start date 2010.3-2011.10 • PPV for recall and biopsy through DBT (start date 2011.3-2012.10 implementation) through 2012.12.31) Friedewald SM et al. JAMA. 2014 Skaane P et al. Radiology 2014 Annual DBT to MG Breast cancer screening with DBT • Improved outcomes (CDR , RR ) observed Per 1000 screens DM DM+DBT Difference –16 ( P < .001) Recall rate 107 91 after initial implementation of DBT screening are sustainable over time? 1.3 ( P = .004) Biopsy 18.1 19.3 DM DBT P DBT P DBT P 1.2 ( P < .001) Cancer detection 4.2 5.4 Characteristic 0 1 value 2 value 3 value 1.2 ( P < .001). Invasive cancer 2.9 4.1 Recall 104 88 <.0001 90 .0005 92 .0025 n/1000 DCIS 1.4 1.4 0 Biopsy 18 20 .167 19 .606 19 .597 n/1000 2.1 ( P < .001) PPV for recall 4.3 6.4 Cancer 4.6 5.5 .370 5.8 .196 6.1 .110 n/1000 5.0 ( P < .001). PPV for biopsy 24.2 29.2 ES McDonald et al. JAMA oncol. 2016 Friedewald SM et al. JAMA. 2014;311(24): 2499-2507 6

  7. 6/7/2017 Lesion Characterization with DBT Rt: Invasive ductal carcinoma, Lt: Fibroadenoma F/51, pain in left breast Capture slices of DBT 2D FFDM Detection of MG occult architectural Detection of MG occult architectural distortion on DBT screening: Initial distortion on DBT screening: Initial clinical experience clinical experience • Retrospective review of BI-RADS category 0 reports from 9982 • Review identified 26 cases of AD screening DM examinations with adjunct DBT were searched – 19 (73%) of which were seen only on the DBT images. for the term "architectural distortion" and were reviewed in – 6 seen better on DBT than DM. consensus by three radiologists. – On diagnostic workup, 9 were assigned to BI-RADS • ADs were classified by whether they were seen better on DM or category 4 or 5. DBT, were seen equally well on both, or were occult on either • 2 IDC, 2 DCIS, 3 Radial scars, 2 atypia. modality. • CDR of DBT in MG occult AD was 21% (4/19). • The electronic medical record was reviewed to identify • US not visible AD: more likely radial sclerosing lesion than additional imaging studies, biopsy results, and surgical excision carcinoma pathology results. Partyka et al. AJR 2014 Partyka et al. AJR 2014 7

  8. 6/7/2017 Asx, 50/F Asx, F/51 Lobular carcinoma in situ 2014 Jan MG 2015 Jan, Tomo 2015 Jan MG 2015 July, Tomo Digital Breast Tomosynthesis • Limitation – US after DBT still detect a few cancers – The factors affecting DBT performances has not been well investigated » Tumor factors : size, subtype, tumor shape, margin, etc.. » Patient factors: age, breast density, etc.. Infiltrating ductal carcinoma, histologic grade I Marker insertion after US guided vacuum biopsy IDC, Grade I 8

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