Breast cancer screening with digital breast tomosynthesis: Is independent double reading still required?

Abstract

Purpose

The European guidelines recommend independent double reading in mammography screening programs. The prospective randomized controlled trial TOSYMA tested the superiority of digital breast tomosynthesis and synthetic mammography (DBT+SM) over digital mammography (DM) for invasive breast cancer detection. This sub-analysis compares the true-positive readings of screening-detected breast cancers resulting from independent double readings in the two trial arms.

Materials and Methods

The 1:1 randomized TOSYMA trial was executed in 17 screening units between 07/2018 and 12/2020. This sub-analysis included 49,762 women in the test arm (DBT+SM) and 49,796 women in the control arm (DM). The true-positive reading results (invasive breast cancers and ductal carcinoma in situ) from 83 readers were determined and merged in a double reading result.

Results

DBT+SM screening detected 416 women with breast cancer and DM screening detected 306. Double readings of DBT+SM examinations led to a single true-positive together with a single false-negative result in 26.9 % of cancer cases (112/416), and in 22.2 % of cases (68/306) in the DM examinations. The cancer detection rate with discordant reading results was 2.3 per 1,000 women screened with DBT+SM and 1.4 per 1,000 with DM. Discordant reading results occurred most often for invasive breast cancers [DBT+SM 75.9 % (85/112), DM 67.6 % (46/68)], category T1 [DBT+SM 67.9 % (76/112), DM 55.9 % (38/68)], and category 4a [DBT+SM: 67.6 % (73/112); DM: 84.6 % (55/68)].

Conclusion

The higher breast cancer detection rate with DBT screening includes a relevant percentage of breast cancers that were only detected by one reader in an independent double reading. As in digital mammography, independent double reading continues to be justified in screening with digital breast tomosynthesis.

Key Points

• The percentages of discordant cancer reading results were 26.9 % and 22.2 % for DBT+SM and DM, respectively.

• The single true-positive detection rate was 2.3 ‰ for DBT+ SM and 1.4 ‰ for DM.

• A relevant proportion of screening-detected cancers resulted from a single true-positive reading.

Citation Format

• Weigel S, Hense HW, Weyer-Elberich V et al. Breast cancer screening with digital breast tomosynthesis: Is independent double reading still required?. Fortschr Röntgenstr 2024; 196: 834 – 842

Keywords

breast cancer - digital breast tomosynthesis - independant double reading - screening

Publication History

Received: 25 August 2023

Accepted: 15 November 2023

Article published online:
31 January 2024

• References

• 1 Lauby-Secretan B, Scoccianti C, Loomis D. et al. Breast-cancer screening – viewpoint of the IARC Working Group. N Engl J Med 2015; 372: 2353-2358
• 2 Marmot MG, Altman DG, Cameron DA. et al. The benefits and harms of breast cancer screening: an independent review. Br J Cancer 2013; 108: 2205-2240
• 3 Waldmann A, Hübner J, Katalinic A. Trends Over Time in Breast-Cancer-Specific Mortality in Germany. Dtsch Arztebl Int 2021; 118: 538-539
• 4 Perry N, Broeders M, de Wolf C. et al. European guidelines for quality assurance in breast cancer screening and diagnosis, 4th edn. Luxembourg: Office for Official Publications of the European Communities; 2006
• 5 Heindel W, Bock K, Hecht G. et al. Systematic and quality-assured early diagnosis of sporadic breast cancer: Update on screening effects and scientific studies. Radiologe 2021; 61: 126-136
• 6 Chong A, Weinstein SP, McDonald ES. et al. Digital breast tomosynthesis: concepts and clinical practice. Radiology 2019; 292: 1-14
• 7 Weigel S, Gerss J, Hense HW. et al. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial. BMJ Open 2018; 14 (05) e020475
• 8 Heindel W, Weigel S, Gerß J. et al. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol 2022; 23: 601-611
• 9 Weigel S, Heindel W, Hense HW. et al. Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis. Radiology 2023; 306 (02) e221006
• 10 Weigel S, Heindel W, Decker T. et al. Digital Breast Tomosynthesis versus Digital Mammography for Detection of Early-Stage Cancers Stratified by Grade: A TOSYMA Subanalysis. Radiology 2023; 309 (03) e231533
• 11 DʼOrsi CJ, Mendelson EB, Ikeda DM. et al. Breast Imaging Reporting and Data System: ACR BI-RADS – breast imaging atlas, 4th ed. Reston, VA: American College of Radiology; 2003
• 12 DʼOrsi CJ, Sickles EA, Mendelson EB. et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System, 5th ed. Reston, VA: American College of Radiology; 2013
• 13 Hofvind S, Geller BM, Rosenberg RD. et al. Screening-detected breast cancers: discordant independent double reading in a population-based screening program. Radiology 2009; 253: 652-660
• 14 Martiniussen MA, Sagstad S, Larsen M. et al. Screen-detected and interval breast cancer after concordant and discordant interpretations in a population based screening program using independent double reading. Eur Radiol 2022; 32: 5974-5985
• 15 Thurfjell EL, Lernevall KA, Taube AA. Benefit of independent double reading in a population-based mammography screening program. Radiology 1994; 191: 241-244
• 16 Ciatto S, Del Turco MR, Morrone D. et al. Independent double reading of screening mammograms. J Med Screen 1995; 2: 99-101
• 17 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: 2061-2071
• 18 Euler-Chelpin MV, Lillholm M, Napolitano G. et al. Screening mammography: benefit of double reading by breast density. Breast Cancer Res Treat 2018; 171: 767-776
• 19 Weigel S, Decker T, Korsching E. et al. Calcifications in digital mammographic screening: improvement of early detection of invasive breast cancers?. Radiology 2010; 255: 738-745
• 20 Dahlblom V, Dustler M, Tingberg A. et al. Breast cancer screening with digital breast tomosynthesis: comparison of different reading strategies implementing artificial intelligence. Eur Radiol 2023; 33: 3754-3765
• 21 Raya-Povedano JL, Romero-Martín S, Elías-Cabot E. et al. AI-based Strategies to Reduce Workload in Breast Cancer Screening with Mammography and Tomosynthesis: A Retrospective Evaluation. Radiology 2021; 300: 57-65
• 22 Lång K, Josefsson V, Larsson AM. et al. Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study. Lancet Oncol 2023; 24: 936-944