6/7/2017 Managing Women with Dense Breast in Europe, Many thanks to the organizers Asia: Austrian Radiologists presents their US/Mammo trial • Research Fellow, University California San Francisco (UCSF); Molecular TH. Helbich Imaging Lab.Prof.R.C.Brasch1996-1998 Department of Biomedical Imaging and Image-guided Therapy Division of Molecular and Gender Imaging Bob & Me Medical University of Vienna DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 1 Disclosure Statement Outlook • Current situation in Asia and Europe Research grants: • Density an issue? • SIEMENS Healthcare, Germany • US: current role • GUERBET, France • US: ready for screening? • HOLOGIC – MEDICOR, Germany • Screening trials with US: JAPAN, AUSTRIA • NOVOMED, Austria • US Screening: Costs / Benefits • BRACCO, Italy • Scenarios for the future DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 1
6/7/2017 WHO (IARC-Meeting 2002) MG - SCREENING EU goes with WHO recommendation EU goes with WHO recommendation No evidence that self examination is helpful! No evidence that self examination is helpful! Shanghai trial: Role of � � MG-SCREENING 50 – 70y. MG-SCREENING 50 – 70y. “Self-examination” � � BCA mortality reduction (30%) BCA mortality reduction (30%) � 5-year survival rate in EU-countries identical (+/- 5% � 5-year survival rate in EU-countries identical (+/- 5% No Screening or of difference) of difference) Self - examination � Improve quality of life of women with BCA � Improve quality of life of women with BCA Thomas et al, JNCI 2002 DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Why do we miss a cancer? EU and MG - Screening 15-30% FIN; NL; S; UK; NOR; GER; LUX; E; DK FIN; NL; S; UK; NOR; GER; LUX; E; DK Why do we overdiagnose? 30-51% DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 2
6/7/2017 The Breast on Mammography The dense Breast � Contrast poor (white cancer and white tissue) � density: 4.7-fold increase of risk to develop BCA � density: BCAs later seen (BCA larger & LN+) � density: 18-fold risk of interval cancer � density: largest population of women with 15-25% life time risk Fatty Scattered Density Extremely Dense Two component tissue: � “unpleasant situation”: MG sensitivity low • fatty tissue (dark) and increased risk of BCA • fibroglandular tissue (white) Yaffe et al, Breast Cancer Research 2009 Brem R et al AJR 2014 DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY US of the Breast DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 3
6/7/2017 US guided Breast Biopsy Density and Influence on Sensitivity DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Adjunct Value of Breast US Adjunct Value of Breast US DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 4
6/7/2017 US of the breast REASONS for Cancer Misses at MG • Reasons for nondetection at MG • 355 US only detected BCA � high frequency US � performed by experienced • MGs reviewed (5 rads): indeed negative or recall? technologist or radiologists • 63 (19%) recalled; 272 (81%) no MG findings � has been shown to detect MG occult BCA • 63 (19%) interpretative errors (of: 82% subtle findings) • 272 (81%): 78% overlapping tissue, • and 3% not on MG Brem R et al AJR 2014 DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY REASONS for Cancer Misses at MG REASONS for Cancer Misses at MG • 272 (81%): 78% overlapping tissue, • 272 (81%): 78% overlapping tissue, • and 3% not on MG • and 3% not on MG DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 5
6/7/2017 REASONS for Cancer Misses at US REASONS for Cancer Misses at US • Reasons for non-detection at US • 72 (31%): visible findings • 230 women with 230 pairs of US exams (prior / subsequent) • 57 /72 (79%): actionable findings • all found to have BCA • 2 most finding: 39% misinterpretation ( NOT CIRCUMSCRIBED MARGIN) & 17% multiple distracting lesions • 72 (31%) visible findings • 72 (69%) no findings • No findings: aggressive BCA (Triple-, Grade 2-3; sg) DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY REASONS for Cancer Misses at US REASONS for Cancer Misses at US • 72 (31%): visible findings • Pay ATTENTION • 57 /72 (79%): actionable findings • Margin : non circumscribed • 2 most finding: 39% misinterpretation ( NOT CIRCUMSCRIBED MARGIN) & 17% multiple distracting lesions • Assess multiple lesions separately DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 6
6/7/2017 US of the breast Cochrane Review • Objectives: effectiveness & safety of MG vs. MG&US • For breast cancer screening � IS IT EFECTIVE TO SCREEN • Women at average risk WOMEN WITH DENSE BREAST WITH ULTRASOUND ?? DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Cochrane review (2731 citations) Cochrane Review • Selection: • Randomized controlled trials (RCTs) • Prospective non-randomized controlled trials • Low risk of bias and >500 participants • Efficacy and harms • Population: women 40-75y, AVERAGE RISK FOR BCA DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 7
6/7/2017 Cochrane review EVIDENCE SYNTHESIS 2016 • Conclusion: • “no methodically sound evidence” to justify adjunct US in women at average BCA risk • one study approaching J-START • Purpose: • Review the evidence on the accuracy and reproducibility of the BIRADS – ACR Scoring of breast density • Performance and clinical outcome (HHUS, ABUS, MRI, DBT) DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Effectiveness of Supplement Breast Density Assessment Screening NOT ROBUST! • No gold standard for density determination • No studies which examined the impact of supplement screening on • No studies, which evaluated the accuracy BCA recurrence or mortality • Observational studies: detection rate, recall and BX rates • 70% of women would be placed in the same density category at two exams (30% NOT!!!) by different radiologist • 13-18% complete change (dense to non-dense) • One in five women would be placed into a different density category by the same radiologist at the next screening exam DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 8
6/7/2017 Automated Breast US Supplement Screening � multicenter study 2009-11 � 15318 women (25-94y) � ACR density 3-4 � MG followed by US � Follow-up 1 year � ABUS system (sono.v, U-systems), exam time 15mins.; Reading time for radiologist: 2.9mins. DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Automated Breast US Automated US for screening � BCA: MG: 82; US:112 1668 patients � CA/1000: MG: 5.4; US: 7.3; DIFF 1.9 MG and 3D-ABUS in ACR 3 + 4 � Recall rate/1000: MG: 15%; US: 28% � CA/1000: MG: 4.2; US: 6.6; Sig. Diff: 2.4 � Biopsy/1000: MG: 38; US: 74 � Recall rate/1000: MG: 13%; US: 23% Diff 9%, sig. � Invasive BCA: MG: 62%; US: 93% (sg) � DCIS (33): MG alone 11; US alone 2 US detects more important BCAs DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 9
6/7/2017 Supplement Screening Automated US for screening: Facts Conclusion Automated +/- whole breast US is • BI-RADS density determination not ideal integrated: • No studies which examined the impact of supplement screening on BCA recurrence or Need for more experience mortality Hope to reduce scan time • Supplement screening: Hope to improve image quality • Identification of more BCAs Hope to increase specificity, PPV • More recalls and more BX (CAD systems) • Better outcome? Reduction in overdiagnosis? • Need for RTCs and long term follow up!!!! DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY Supplement Screening Supplement Screening Biopsy rate(4-10%) Conclusion • BI-RADS density determination not ideal • No studies which examined the impact of supplement screening on BCA recurrence or mortality • Supplement screening: • Identification of more BCAs • More recalls and more BX • Better outcome? Reduction in overdiagnosis? • Need for RTCs and long term follow up!!!! DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY DEPARTMENT OF BIOMEDICAL IMAGING AND IMAGE-GUIDED THERAPY 10
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