Randomized clinical trial of risk-based versus annual breast cancer screening

Individual breast cancer risk can guide screening initiation, frequency, use of supplemental imaging, and preventive measures to improve breast cancer screening by shifting resources from low-risk women to high-risk women. The WISDOM randomized clinical trial in the United States investigated whether risk-based breast cancer screening (n=14,212) is a feasible alternative to annual mammography (n=14,160). Risk assessment included sequencing of 9 susceptibility genes, polygenic risk score, and the Breast Cancer Surveillance Consortium version 2 model. Risk-based screening was noninferior to annual screening (rate difference, -18.0 per 100,000 person-years. Women in the highest risk category, assigned to screen every 6 months, had no stage ≥ IIB cancers; no overall reduction in biopsies was observed, but the rates for cancer detection, biopsy, and mammograms increased with rising risk in the risk-based group. The authors conclude that risk-based breast cancer screening is safe and acceptable, offering an opportunity to modernize screening in the precision medicine era (visual abstract).