Tomosynthesis plus digital mammography detects 90% more cancers than digital mammography alone, with similar recall rate. This higher detection may have a beneficial impact on cancer prognosis.

Purpose

To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial.

Materials and Methods

For this trial, eligible women (45–70 years old) who previously participated in the Reggio Emilia screening program were invited for mammography. Consenting women were randomly assigned 1:1 to undergo DBT+DM or DM (both of which involved two projections and double reading). Women were treated according to the decision at DBT+DM. Sensitivity, recall rate, and positive predictive value (PPV) at baseline were determined; the ratios of these rates for DBT+DM relative to DM alone were determined.

Results

From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; −12 [95% CI: −68, 141]; for invasive cancers < 10 mm, 10–19 mm, and ≥ 20 mm, respectively).

Conclusion

DBT+DM depicts 90% more cancers in a population previously screened with DM, with similar recall rates.

© RSNA, 2018

Online supplemental material is available for this article.

References

  • 1. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 2012;380(9855):1778–1786. Crossref, MedlineGoogle Scholar
  • 2. European Commission Initiative on Breast Cancer. Recommendations on breast cancer screening. http://ecibc.jrc.ec.europa.eu/recommendations/list/3. Accessed May 24, 2017. Google Scholar
  • 3. Dibden A, Offman J, Parmar D, et al. Reduction in interval cancer rates following the introduction of two-view mammography in the UK breast screening programme. Br J Cancer 2014;110(3):560–564. Crossref, MedlineGoogle Scholar
  • 4. Vedantham S, Karellas A, Vijayaraghavan GR, Kopans DB. Digital breast tomosynthesis: state of the art. Radiology 2015;277(3):663–684. LinkGoogle Scholar
  • 5. Ciatto S, Houssami N, Bernardi D, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol 2013;14(7):583–589. Crossref, MedlineGoogle Scholar
  • 6. Skaane P, Bandos AI, Gullien R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology 2013;267(1):47–56. LinkGoogle Scholar
  • 7. Skaane P, Bandos AI, Gullien R, 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):2061–2071. Crossref, MedlineGoogle Scholar
  • 8. Gilbert FJ, Tucker L, Gillan MG, 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 Assess 2015;19(4):i–xxv, 1–136. CrossrefGoogle Scholar
  • 9. 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;26(1):184–190. Crossref, MedlineGoogle Scholar
  • 10. Lång K, Nergården M, Andersson I, Rosso A, Zackrisson S. False positives in breast cancer screening with one-view breast tomosynthesis: an analysis of findings leading to recall, work-up and biopsy rates in the Malmö Breast Tomosynthesis Screening Trial. Eur Radiol 2016;26(11):3899–3907. Crossref, MedlineGoogle Scholar
  • 11. Bernardi D, Macaskill P, Pellegrini M, 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):1105–1113. Crossref, MedlineGoogle Scholar
  • 12. US Food and Drug Administration. Premarket approval. SENOCLAIRE. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P130020S001. Accessed May 24, 2017. Google Scholar
  • 13. McDonald ES, Oustimov A, Weinstein SP, Synnestvedt MB, Schnall M, Conant EF. Effectiveness of digital breast tomosynthesis compared with digital mammography: outcomes analysis from 3 years of breast cancer screening. JAMA Oncol 2016;2(6):737–743. Crossref, MedlineGoogle Scholar
  • 14. Oeffinger KC, Fontham ETH, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 guideline update from the American Cancer Society. JAMA 2015;314(15):1599–1614. Crossref, MedlineGoogle Scholar
  • 15. Siu AL; U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2016;164(4):279–296. Crossref, MedlineGoogle Scholar
  • 16. Campari C, Giorgi Rossi P, Mori CA, et al. Impact of the introduction of digital mammography in an organized screening program on the recall and detection rate. J Digit Imaging 2016;29(2):235–242. Crossref, MedlineGoogle Scholar
  • 17. Puliti D, Duffy SW, Miccinesi G, et al. Overdiagnosis in mammographic screening for breast cancer in Europe: a literature review. J Med Screen 2012;19(Suppl 1):42–56. Crossref, MedlineGoogle Scholar
  • 18. Ronco G, Segnan N. HPV testing for primary cervical cancer screening. Lancet 2007;370(9601):1740–1742. Crossref, MedlineGoogle Scholar
  • 19. American College of Radiology. Breast Imaging and Reporting Data System. 5th ed. Vol A. Reston, Va: American College of Radiology, 2004. Google Scholar
  • 20. Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies: improving the management of early breast cancer—St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol 2015;26(8):1533–1546. Crossref, MedlineGoogle Scholar
  • 21. Bucchi L, Ravaioli A, Foca F, et al. Incidence of interval breast cancers after 650,000 negative mammographies in 13 Italian health districts. J Med Screen 2008;15(1):30–35. Crossref, MedlineGoogle Scholar
  • 22. Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology 2006;241(1):55–66. LinkGoogle Scholar
  • 23. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas 1960;20(1):37–46. CrossrefGoogle Scholar
  • 24. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 2014;311(24):2499–2507. Crossref, MedlineGoogle Scholar
  • 25. 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(1):9. Crossref, MedlineGoogle Scholar
  • 26. Lourenco AP, Barry-Brooks M, Baird GL, Tuttle A, Mainiero MB. Changes in recall type and patient treatment following implementation of screening digital breast tomosynthesis. Radiology 2015;274(2):337–342. LinkGoogle Scholar
  • 27. Perry N, Broeders M, de Wolf C, et al. European Commission. European guidelines for quality assurance in breast cancer screening and diagnosis. 4th ed. Luxembourg: European Communities, 2006. Google Scholar
  • 28. Hofvind S, Ponti A, Patnick J, et al. False-positive results in mammographic screening for breast cancer in Europe: a literature review and survey of service screening programmes. J Med Screen 2012;19(Suppl 1):57–66. Crossref, MedlineGoogle Scholar
  • 29. Hodgson R, Heywang-Köbrunner SH, Harvey SC, et al. Systematic review of 3D mammography for breast cancer screening. Breast 2016;27:52–61. Crossref, MedlineGoogle Scholar
  • 30. Ernster VL, Barclay J, Kerlikowske K, Grady D, Henderson C. Incidence of and treatment for ductal carcinoma in situ of the breast. JAMA 1996;275(12):913–918. Crossref, MedlineGoogle Scholar
  • 31. Cuzick J, Sestak I, Pinder SE, et al. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. Lancet Oncol 2011;12(1):21–29. Crossref, MedlineGoogle Scholar
  • 32. Duffy SW, Dibden A, Michalopoulos D, 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):109–114. Crossref, MedlineGoogle Scholar
  • 33. Bernardi D, Ciatto S, Pellegrini M, et al. Application of breast tomosynthesis in screening: incremental effect on mammography acquisition and reading time. Br J Radiol 2012;85(1020):e1174–e1178. Crossref, MedlineGoogle Scholar
  • 34. Dang PA, Freer PE, Humphrey KL, Halpern EF, Rafferty EA. Addition of tomosynthesis to conventional digital mammography: effect on image interpretation time of screening examinations. Radiology 2014;270(1):49–56. LinkGoogle Scholar

Article History

Received: Sept 24 2017
Revision requested: Nov 8 2017
Revision received: Jan 24 2018
Accepted: Jan 24 2018
Published online: June 05 2018
Published in print: Aug 2018