HHE Radiology and imaging supplement 2018

DBT=digital breast tomosynthesis; DCIS=ductal carcinoma in situ; DM=digital mammography Flowchart of recruitment phase and study design Cancers Detected with DBT Only Potentially eligible presented for screening 33198 9662 women received the complete experimental procedure 66 received DM only*: 3 were recalled: 1 had cancer 1 had lesion of uncertain malignant Potential 49 had incomplete DBT imaging or registration*: 13 were recalled, 2 had cancer, and 1 had lesion of uncertain malignant potential 0 72 DBT + DM arm 9777 Excluded 2209 (large breasts, familial risk score update recent breast cancer in relatives, augmentation prostheses, pregnancy, randomization procedure or tomosynthesis temporary not available) Eligible 30989 8 Refusals 11429 Randomization disclorure 19560 DM arm 9783 positive 344 positive 339 cancers 84 cancers 44 negative 9433 DM to identify significantly more lesions with fewer false-positives and similar recall rates compared with DM alone continues to expand. Several large, multicentre clinical trials are currently underway that will, hopefully, answer some of the remaining questions currently preventing the greater adoption of DBT in the clinical setting. negative 9444 80 1 or 2 1 or 2 5 DCIS) 5 DCIS) in 3D years Detected in at least one (including of the 2 reading (including rounds years Interval Detected in 2D but not in 3D cancers Interval cancers DM at Next screening Round DM at Next screening Round Interval 1 or 2 Interval cancers 1 or 2 cancers years Tomosynthesis vs Digital Mammography: years Diagnostic Breast DM at Next DM at Next screening Round screening Round Detection by Cancer Size Cancers 31% Detected with 31% DBT Only DBT=digital breast tomosynthesis; DCIS=ductal carcinoma in situ; DM=digital mammography Figure 1 Flowchart of recruitment phase and study design. Control Arm Study Arm 16% 14% 14% 72 8 5% 0 Lesion size < 10 mm Lesion size ≥ 10 mm to < 20 mm DCIS 80 Detected in at least one of the 2 reading rounds in 3D Detected in 2D but not in 3D Figure 2 Cancers detected with DBT only vs Digital Mammography: Diagnostic Breast Tomosynthesis Detection by Cancer Size 31% 31% Control Arm Study Arm 16% 14% 14% 5% Lesion size < 10 mm Lesion size ≥ 10 mm to < 20 mm DCIS Figure 3 DBT vs digital mammography: Detection by cancer size for DBT + DM versus DM alone, the increase was related to positive studies, suggesting it resulted from the need to review multiple images, not the interpretation itself. Variability between readers was similar in both arms. 17 “Our data confirms the excellent results of 3D mammography, previously evidenced in other European prospective studies carried out on large-popula tion screening programs,” said the lead investigator, Pierpaolo Pattacini, MD. “But our results go a step further: only randomised trials can evaluate the effectiveness of a new screening technology, like whether it can save more lives.” Conclusions The body of evidence as to the ability of DBT + 13 HHE 2018 | hospitalhealthcare.com References 1 EUCAN. Estimated incidence and mortality from breast cancer, 2012. International Agency for Research on Cancer. World Health Organization 2017. 2012; http://eco.iarc.fr/eucan (accessed July 2018). 2 Ferlay J et al. GLOBOCAN 2012 v1.1, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2014. http://globocan. iarc.fr (accessed July 2018). 3 Altobelli E, Lattanzi A. Breast cancer in European Union: an update of screening programmes as of March 2014 (review). Int J Oncol 2014;45(5):1785–92. 4 Paap E et al. A remarkable reduction of breast cancer deaths in screened versus unscreened women: a case-referent study. Cancer Causes Control 2010;21(10):1569–73. 5 Tabar L et al. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology 2011;260(3):658–63. 6 Paci E, Group EW. Summary of the evidence of breast cancer service screening outcomes in Europe and first estimate of the benefit and harm balance sheet. J Med Screen 2012;19 Suppl 1:5–13. 7 Nelson HD et al. Harms of breast cancer screening: Systematic review to update the 2009 U.S. Preventive Services Task Force Recommendation. Ann Intern Med 2016;164(4):256–67. 8 Vedantham S et al. Digital breast tomosynthesis: State of the art. Radiology 2015;277(3):663–84. 9 Dabbous FM et al. Impact of a false-positive screening mammogram on subsequent screening behavior and stage at breast cancer diagnosis. Cancer Epidemiol Biomarkers Prev 2017;26(3):397–403. 10 Skaane P et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology 2013;267(1):47–56. 11 Gilbert FJ et al. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technol Asses. 2015;19(4):i-xxv, 1–136. 12 Caumo F et al. Incremental effect from integrating 3D-mammography (tomosynthesis) with 2D-mammography: Increased breast cancer detection evident for screening centres in a population-based trial. Breast (Edinburgh, Scotland) 2014;23(1):76–80. 13 Friedewald SM, Rafferty EA, Conant EF. Breast cancer screening with tomosynthesis and digital mammography-reply. JAMA 2014;312(16):1695–6. 14 Skaane P et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology 2014;271(3):655–63. 15 Sardanelli F et al. Position paper on screening for breast cancer by the European Society of Breast Imaging (EUSOBI) and 30 national breast radiology bodies from Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Israel, Lithuania, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland and Turkey. Eur Radiol. 2017;27(7):2737–43. 16 European Commission Initiative on Breast Cancer. Recommendations on breast cancer screening. http://ecibc.jrc. ec.europa.eu/recommendations/list/3 (accessed July 2018). 17 Pattacini P et al. Digital mammography versus digital mammography plus tomosynthesis for breast cancer screening: The Reggio Emilia Tomosynthesis Randomized Trial. Radiology 2018:172119. 18 Skaane P et al. Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration. Eur Radiol 2013;23(8):2061–71. 19 Lang K et al. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol 2016;26(1):184–90. 20 McDonald ES et al. Effectiveness of digital breast tomosynthesis compared with digital mammography: Outcomes analysis from 3 years of breast cancer screening. JAMA Oncol 2016;2(6):737–43. 21 Destounis S, Arieno A, Morgan R. Initial experience with combination digital breast tomosynthesis plus full field digital mammography or full field digital mammography alone in the screening environment. J Clin Imaging Sci 2014;4:9. 22 Bernardi D et al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population- based prospective study Lancet Oncol 2016;17(8):1105–13. 23 Barrio AV, Van Zee KJ. Controversies in the treatment of DCIS. Annu Rev Med 2017;68:197–211. 24 Duffy SW et al. Screen detection of ductal carcinoma in situ and subsequent incidence of invasive interval breast cancers: a retrospective population-based study. Lancet Oncol 2016;17(1):109–14.

HHE Radiology and imaging supplement 2018 | Page 13