6/7/2017 Disclosures Breast Density in the Tomosynthesis World • Travel support and speaker’s fees SOPHIA ZACKRISSON MD PH.D, ASSOCIATE PROFESSOR SENIOR LECTURER, DIAGNOSTIC RADIOLOGY � Siemens Healthineers SKÅNE UNIVERSITY HOSPITAL MALMÖ � Astra Zeneca SWEDEN Outline ① Prospective trials- results and differences ② Retrospective studies – added value? ③ DBT and density ④ What evidence is needed to switch to tomoscreening? 1
6/7/2017 DM DBT 54-y-old woman 13 mm inv ductal ca grade 2; DCIS 2
6/7/2017 MAMMOGRAPHY CC MLO The major limitation in 2D mammography is overlapping tissue = anatomical noise = dense breast tissue ULTRASOUND 3
6/7/2017 TOMOSYNTHESIS MAMMOGRAPHY BT Tomosynthesis is a better mammography 3 cm invasive ductal carcinoma grade 3 with metastasis to axilla So why wait? Outline • Evidence based medicine ① Prospective trials- results and differences ② Retrospective studies – added value? • European guidelines for breast cancer screening ③ DBT and density • -> screening of healthy women ④ What evidence is needed to switch to • -> majority do not have breast cancer tomoscreening? • -> we must know what we are doing! 4
6/7/2017 1 Prospective trials - published Summary prospective trials ① STORM 1 (N=7,300) • 30% increased cancer detection ② OSLO (interim N=12,500) • DBT better in all density categories ③ MBTST (interim N=7,500) • Predominantly invasive cancers ④ STORM 2 (N=9,600) • Low base line recall rates • Acceptable recall rates Ciatto et al, Lancet Oncol 2013 • Prevalence effect Houssami et al, Euro J Ca 2014 Skaane et al, Radiol 2013 Skaane et al, Euro Radiol 2013 Lång et al, Eur Radiol 2016 Lång et al, Eur Radiol 2016 Bernardi et al, Lancet Oncol 2016 Trial and publications Study design (n screens) Screen-reading practice & context 1 Prospective trials - ongoing • • Ciatto et al 2013 [STORM trial] Lancet Prospective trial (7,292) in Italian Sequential read of 2D Oncology screening program then 2D/3D • • 2D compared to integrated 2D/3D Independent double- reading ① OSLO (N=25000) • Houssami et al 2014 [STORM 12-month No arbitration follow-up] Euro J Ca ② STORM (N=7300) • • Bernardi et al 2016 [STORM 2 trial] Prospective trial (9,672) in Italian Sequential read of 2D screening program then 2D/3D or 3D+ ③ MBTST (N=15000) • 2D compared to 3D + synthetic 2D and synthetic • integrated 2D/3D Independent double- ④ STORM 2 (N=9600) reading • No arbitration ⑤ TMIST, Canada/US? • • Skaane et al, 2013 [Interim report Oslo Prospective trial (12,631 in interim, Four reading arms (2 trial] Radiol 25000 full study) in Norwegian readers per arm) • ⑥ TOBE, Bergen, Norway screening program Independent double- • 2D compared to several strategies: reading • Skaane et al 2013 Euro 2D+3D/3D+CAD/3D+ synthetic 2D Arbitration ⑦ Piemonte, Italy Radiol • • Lång et al 2016 [Interim report Prospective trial (7,500 in interim 1-view 3D ⑧ Reggio Emilia, Italy • MBTST]** Eur Radiol analysis, 15000 in full study) random Independent double- sample invited in Swedish screening reading Lång et al 2016 [Interim report MBTST • program Arbitration ⑨ UK, Netherlands??… FP recall] Eur Radiol • 2D versus stand-alone 1-view 3D 5
6/7/2017 Recall rates – prospective trials Detection rates – prospective trials Detection rate/1000 Increased Double reading Recall rate (%) Change detection Double reading DM DM+DBT • Not comparable study design DM DM+DBT STORM 5.3 8.1 27% • Not representing “true screening situation” (Ciatto; Lancet Oncol 2013) STORM (estimated, not actual) 4.4 3.5 ↓ (Ciatto; Lancet Oncol 2013) OTST 7.1 9.4 30% (Skaane; Eur Radiol 2013) OTST 2.9 3.7 ↑ • Similar results (Skaane; Eur Radiol 2013) MBTST 6.3 8.9 43% (Lang; Eur Radiol 2015)) (1 view DBT) MBTST 2.6 1 view DBT ↑ • Prevalence effect (Lang; Eur Radiol 2015)) 3.8 STORM 2 DM DBT + synth 40% (Bernardi; Lancet Oncol 2016) DM STORM 2 DM DBT + synth DM ↑ 6.3 8.8 (Bernardi; Lancet Oncol 2016) 3.4* 4.5* * Reported as false positive recall rate FALSE POSITIVE 1-yr follow-up MAMMOGRAPHY TOMOSYNTHESIS MBTST • Women aged 40-74 ys • 1-view (MLO) • Wide-angle system • Reduced compression (30-50%) • Full study results 2017 6
6/7/2017 Outline Less compression • Vigorous (standard) compression vs half compression force ① Prospective trials- results and differences • No significant difference in image quality • Pressure measurements ② Retrospective studies – added value? ③ DBT and density ④ What evidence is needed to switch to tomoscreening? Standard 50% Distribution Förnvik D et al. Radiat Prot Dosim 2010 Dustler M et al. Acta Radiol 2012 Retrospective studies – DM vs DM+DBT 2 Retrospective studies N Cancer Recall rate Change DM vs DM+DBT detection/1000 % recall rate women • 2D compared to 2D/3D Rose AJR 2013 13.000 vs 9.500 4.0 vs 5.4 8.7 vs 5.5 * -37% • Compare different cohorts with 2D and 2D/3D Friedewald JAMA 2014 270.000 vs 174.000 4.2 vs 5.4 * 11 vs 9.1 * -17% Haas Radiology 2013 13.100 vs 6.100 5.2 vs 5.7 12 vs 8.4 * -30% • Different time periods McCarthy JNCI 2014 10.700 vs 15.500 4.6 vs 5.5 10.4 vs 8.8 * -15% Greenberg AJR 2014 54.600 vs 23.100 4.9 vs 6.3 * 16.2 vs 13.6 -16% • Annual screening Lourenco Radiol 2015 12.921 vs 12.577 5.4 vs 4.6 9.3 vs 6.4 * -45% • No specified inclusion criteria McDonald JAMA Onc 44.468 (repeated DBT 4.6 vs 5.5, 5.8, and 10.4 vs 8-9 * -23 to -34% 2016 screens) year 0-3 6.1 Rose AJR 2013 Haas Radiology 2013 Conant Br Res Treat 2016 142.883 vs. 55.998 5.9 vs 4.4* 10.4 vs 8.7* -20% McCarthy JNCI 2014 Greenberg AJR 2014 Lourenco Radiol 2015 McDonald JAMA Onc 2016 Conant Br Res Treat 2016 * Statistically significant Zuckerman Radiol 2016 (Synthetic 2D+DBT) 7
6/7/2017 Retrospective studies – DM vs DM+DBT Outline • + Large studies ① Prospective trials- results and differences ② Retrospective studies – added value? • - Selection bias ③ DBT and density • Not organized screening ④ What evidence is needed to switch to • None or small effect on detection rates tomoscreening? • Higher base-line recall rates (8-16%) -> large reductions with DBT Rose AJR 2013 Haas Radiology 2013 McCarthy JNCI 2014 Greenberg AJR 2014 Lourenco Radiol 2015 McDonald JAMA Onc 2016 Conant Br Res Treat 2016 Zuckerman S 2016 (Synthetic 2D + DBT) 68-y-old asymptomatic woman (screening)) CC MLO Cancer detection by density in MBTST (n=7,500) Breast density BIRADS Detected DBT total Detected DBT Detected DM Detected 4th alone total DM alone Fatty (<25%) 7 (10) 3 (14) 4 (9) Scattered (25-50%) 17 (25) 5 (24) 12 (26) Heterogeneous (51-75%) 33 (49) 10 (48) 24 (51) 1 (100) Dense (>75%) 10 (15) 3 (14) 7 (15) 38% in non-dense breasts Lång K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2016 Jan;26(1):184-90. 8
6/7/2017 3D 2D Pathology: 1.0 cm ductal carcinoma gr 1 Interim report of ASTOUND (Tagliafico et al JCO 2016) Interim report of ASTOUND (N=3,231) Prof Nehmat Houssami Prof Nehmat Houssami Italian population-based: recruitment from 5 Italian � Detected 24 additional BCs centres with dedicated � 12 detected on tomosynthesis & ultrasound breast imaging facilities � 1 dx only on tomosynthesis � 11 dx only on ultrasound Eligible: Asymptomatic � Incremental CDR tomosynthesis 4.0/1000 screens (1.8–6.2) versus ultrasound 7.1/1000 women self-referring to screens (4.2–10.0), P=0.006 screening � Incremental FPR 3.33% * Breast density 3-4 Age ≥ 38 years Tagliafico et al JCO 2016 * Live density reporting to action tomosynthesis acquisition at same breast compression 9
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