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Rofo 2026; 198(01): 85-92
DOI: 10.1055/a-2544-9085
Breast

Radiological Tumor Signs of Breast Cancer in UICC Stage I: Subanalysis of the Randomized Controlled Trial TOSYMA

Article in several languages: deutsch | English

Authors

  • Stefanie Weigel 

    1   Clinic for Radiology and Reference Center for Mammography Münster, University of Münster Faculty of Medicine, Münster, Germany (Ringgold ID: RIN98883)

  • Hans Werner Hense 

    2   Institute of Epidemiology and Social Medicine, University of Münster Faculty of Medicine, Münster, Germany (Ringgold ID: RIN98883)

  • Veronika Weyer-Elberich

    3   Institute of Biostatistics and Clinical Research, University of Münster Faculty of Medicine, Münster, Germany (Ringgold ID: RIN98883)

  • Joachim Gerss 

    3   Institute of Biostatistics and Clinical Research, University of Münster Faculty of Medicine, Münster, Germany (Ringgold ID: RIN98883)

  • Walter Heindel 

    1   Clinic for Radiology and Reference Center for Mammography Münster, University of Münster Faculty of Medicine, Münster, Germany (Ringgold ID: RIN98883)


Supported by: Deutsche Forschungsgemeinschaft HE 1646/5-1,HE 1646/5-2

Clinical Trial:

Registration number (trial ID): NCT03377036, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: RCT


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Abstract

Purpose

The randomized controlled, multicenter TOSYMA study showed a superiority of the combination of digital breast tomosynthesis and synthetic mammography (DBT+SM) over digital mammography (DM) in the detection rate of invasive breast cancer at stage UICC I. In this subanalysis, we compared the mammographic tumor signs of UICC I stage breast cancers detected in each study arm and stratified according to histological grade.

Materials and Methods

This subanalysis included 49,462 women in the DBT+SM arm and 49,669 women in the DM arm after 1:1 randomization from July 2018 to December 2020. The mammographic abnormalities documented at the consensus conference were collected for breast cancers in stage UICC I based on various tumor signs (such as masses, microcalcifications, architectural distortions, or their combinations). The detection rates (per 10,000 screened women) were calculated with differentiation of grade 1 and grade 2 or 3 cancers.

Results

Grade 1 cancers were detected using DBT+SM in 6.5/10,000 screened women only by masses (+1.5/10,000 versus DM), in 2.4/10,000 (+1.6/10,000) by architectural distortions, and in 1.2/10,000 (+0.8/10,000) by microcalcifications. Combinations of tumor signs were present in 7.9/10,000 (+6.1/10,000) screened women. Grade 2 or 3 cancers were detected by DBT+SM in 13.7/10,000 by masses (+2.6/10,000 versus DM), in 4.9/10,000 by microcalcifications (+2.3/10,000), and in 3.6/10,000 by architectural distortions (+2.0/10,000). Combinations were present in 10.1/10,000 (+6.3/10,000) screened women.

Conclusion

In DBT+SM screening, the detection rate of UICC I breast cancers is higher compared to DM: both, individual tumor signs and their combinations contribute to this finding. The detection rate of UICC I grade 2 or 3 cancers is higher in DBT+SM screening than in DM screening mainly due to the combination of tumor signs.

Key Points

  • DBT+SM detects more grade 2 or 3-UICC I breast cancers than DM.

  • This increase in detection rate results mainly from a combination of tumor signs.

  • Nearly half of the increase relates to individual signs: masses, microcalcifications, and architectural distortions.

Citation Format

  • Weigel S, Hense HW, Weyer-Elberich V et al. Radiological Tumor Signs of Breast Cancer in UICC Stage I: Subanalysis of the Randomized Controlled Trial TOSYMA. Rofo 2026; 198: 85–92

Keywords

breast - digital radiography - screening - breast cancer - digital breast tomosynthesis - digital mammography


Publication History

Received: 02 September 2024

Accepted after revision: 17 February 2025

Article published online:
26 March 2025

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