Led by Stefanie Weigel, MD, from the University of Münster and University Hospital Münster in Germany, the study analyzed data from nearly 100,000 participants in the TOmo-synthesis plus SYnthesized MAmmography (TOSYMA) trial, conducted between 2018 and 2020. The subanalysis focused on comparing false-positive recall and biopsy rates between DBT plus SM and standard digital mammography, as well as the positive predictive values (PPV) of recalls and biopsies.
The subanalysis included 49,715 women screened with DBT plus SM and 49,762 women screened with DM. It led to the following findings:
- DBT plus synthesized mammography (SM) resulted in a lower overall recall rate (48.6 per 1,000 women) compared with digital mammography (DM) (49.9 per 1,000 women).
- The true-positive recall rate was higher with DBT plus SM (8.4 per 1,000) versus DM (6.2 per 1,000), indicating better cancer detection.
- False-positive recall rates were lower with DBT plus SM (40.2 per 1,000) than with DM (43.7 per 1,000), particularly among first-time screening participants.
- DBT plus SM slightly increased false-positive biopsy rates (7.8 per 1,000) compared to DM (6 per 1,000), but this was offset by higher cancer detection.
- The positive predictive value (PPV) of recalls was higher with DBT plus SM at 17.2% versus 12.3% for DM.
- The PPV of biopsies performed with DBT plus SM reached 51.7%.
- Interval cancers following false-positive recalls were rare in both groups.
The researchers suggested that the reduced false-positive recalls in first-round screenings with DBT plus SM may be due to fewer summation shadows, which often lead to unnecessary recalls in standard digital mammography. In subsequent rounds, comparisons with prior mammograms reduce the difference in false-positive recalls between the two methods.
Although the combined approach slightly raised benign surgical excisions (1.2 per 1,000 women screened versus 0.6 per 1,000 with DM), the gain in detected cancers offset this drawback. “The mildly higher false-positive biopsies are compensated by the increased detection of breast cancers,” the authors noted.
An
accompanying editorial by Benoît Mesurolle, MD, from France, and Mona El Khoury, MD, from Canada, emphasized that these findings support broader adoption of DBT plus synthesized mammography. They noted that replacing standard digital mammography with the combined approach could reduce radiation exposure without compromising screening effectiveness.
The subanalysis of the TOSYMA trial adds to the growing evidence that DBT, especially when paired with synthesized mammography, offers a more precise and efficient tool for population-based breast cancer screening. By lowering unnecessary recalls and enhancing cancer detection, this approach may improve the overall effectiveness and patient experience of mammography programs.
Reference:
Weigel S, Hense HW, Weyer-Elberich V, Gerß J, Heindel W; TOSYMA Screening Trial Group. False-Positive Recall and False-Positive Biopsy Rates in Mammography Screening: A TOSYMA Trial Subanalysis. Radiology. 2025 Sep;316(3):e251014. doi: 10.1148/radiol.251014. PMID: 40956160.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.