Early detection of disease is hailed as a positive step in healthcare, but what happens when it uncovers “too much?” While early diagnosis can boost recovery chances, it can also bring unintended consequences.

The world’s largest randomized diagnostic superiority study on early breast cancer detection, known as TOSYMA, has explored the implications of the digital breast tomosynthesis (DBT) plus synthetic 2D mammography (SM) method and has once again highlighted the advantages of this approach over the standard screening procedures.

TOSYMA is a groundbreaking project focused on improving the systematic early detection of invasive breast cancer. Researchers at the Germany-based University of Münster, led by Walter Heindel, MD, director of the clinic for radiology at the University Hospital Münster, have published new results in the journal Radiology, showcasing the benefits of the innovative diagnostic approach.

The study, involving nearly 100,000 participants, utilized a combination of DBT and SM. Comparing this DBT+SM approach with conventional digital mammography, the researchers found a significant increase in the detection of invasive breast cancers.

However, the critical question is whether this enhanced detection actually improves women’s health or leads to overdiagnosis. In an exploratory subanalysis, Heindel, professor Stefanie Weigel, MD, and professor Hans-Werner Hense identified that DBT+SM screening can detect relevant tumors, those that could potentially reduce breast cancer mortality compared to less aggressive variants.

“From the results of the subanalysis, we conclude that the higher rate of early tumor stages of tumor grades 2 and 3 using DBT+SM could increase the screening effect with regard to breast cancer mortality,” Weigel says, adding another “plus point” for DBT+SM.

The next phase of research is already underway, the researchers say. Data from two German the cancer registries will be analyzed to further examine the screening effect of DBT+SM compared to the previous standard. 

The TOSYMA project, which commenced in 2016 and comprises 17 screening units in Germany, receives financial support from the German Research Foundation, with the current funding period running until 2025.