After a major study suggests risk-based breast cancer screening could be a safe alternative to annual mammography, the American College of Radiology says the data do not justify changes to existing screening recommendations.
The American College of Radiology (ACR) has issued a statement responding to results from the WISDOM study, published in JAMA, in which the authors reported that “[r]isk-based breast cancer screening is safe and acceptable, offering an opportunity to modernize screening in the precision medicine era.”
The WISDOM trial was designed to evaluate whether risk-based breast cancer screening could serve as a feasible alternative to annual mammography. While the ACR acknowledges the researchers’ efforts to explore alternative screening approaches, the organization says that “the study design and results do not provide adequate information to support changes to present screening policies.”
ACR Cites Study Limitations
In its statement, the ACR cites several limitations that it says make it difficult to draw meaningful conclusions about the effectiveness of risk-based screening compared with annual mammography. According to the organization, participant adherence to screening was low across the study, limiting the ability to assess screening outcomes. Both the “annual” screening group and the “risk-based” group had nearly identical and relatively low mammography use, meaning the trial did not meaningfully compare distinct screening strategies. In fact, the ACR notes that “no group had an annual mammogram over the study period.”
The ACR also points to limited use of supplemental imaging. Among participants classified as highest risk, the mean number of breast MRIs over seven years was less than one, and MRI use in other groups occurred outside the structure of the trial. Accrual was lower than expected, and the overall number of cancers detected was small, which the organization says may not be representative of the broader population. Fewer than 300 participants were included in the highest-risk category.
In addition, the trial focused its outcome reporting on cancers staged IIB or higher, the ACR points out, saying this approach excludes many earlier-stage, non-palpable cancers that are a key target of annual mammography, effectively limiting the ability to assess the benefit of early detection through routine screening. The organization also notes that the study required intensive involvement from breast health specialists—an approach that may be difficult to replicate in many clinical settings—yet still resulted in poor adherence to risk-reduction strategies.
The ACR further cites variability in the composition of polygenic risk scores used in the trial and noted that risk assessment models, in general, have only moderate ability to discriminate risk, introducing additional uncertainty.
The organization emphasizes that it continually reviews peer-reviewed evidence from multiple sources to evaluate whether screening recommendations should be updated. Based on its assessment of the WISDOM trial, the ACR says the study does not demonstrate that a risk-based approach is superior to current screening recommendations.
The ACR’s existing breast cancer screening guidelines for average-risk and high-risk women remain in place.
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