Clinical Scorecard: Response to Editorial Inquiry: Comparing Radiation Risks and Screening Outcomes of Digital Breast Tomosynthesis and Mammography—Insights from the TOSYMA Trial Related to Breast Density

At a Glance

Key Highlights

• DBT + SM delivers higher breast radiation doses than DM but may offer improved cancer detection and survival benefits in women with dense breasts.
• Radiation risk assessment in the study is based on the linear no-threshold (LNT) model and lifetime attributable risk (LAR) estimations per BEIR VII guidelines.
• TOSYMA is a large pragmatic randomized controlled trial using multiple certified mammography devices, enhancing real-world applicability and informing national dose reference levels.

Guideline-Based Recommendations

Diagnosis

• Use DBT + SM as an alternative to DM for breast cancer screening, especially in women with dense breasts, to improve detection rates.

Management

• Consider the benefit-risk ratio favoring DBT + SM despite higher radiation doses due to potential survival benefits.
• Incorporate synthetic 2D mammography images reconstructed from DBT data to avoid additional radiation exposure.

Monitoring & Follow-up

• Ongoing evaluation of interval cancer rates and cumulative breast cancer incidence, including advanced cancers, is necessary to assess long-term outcomes.

Risks

• Apply the precautionary principle using the LNT model for radiation risk estimation, acknowledging uncertainties at low doses.
• Recognize variability in radiation exposure across different mammography devices and vendors.

Patient & Prescribing Data

Women participating in breast cancer screening programs, stratified by breast density and age

DBT + SM may increase radiation dose but offers improved cancer detection; synthetic mammography avoids double exposure; economic evaluations and risk-adapted screening strategies are needed for implementation.

Clinical Best Practices

• Adopt DBT + SM screening protocols for women with dense breasts to optimize detection while monitoring radiation exposure.
• Use synthetic mammography images derived from DBT data to minimize radiation dose.
• Support ongoing research on interval cancer rates and advanced cancer incidence to validate screening benefits.
• Consider device variability in radiation dose and apply national dose reference levels for quality assurance.
• Integrate emerging technologies such as artificial intelligence to improve screening efficiency and resource allocation.

References

• BEIR VII Committee Risk Models