The landmark Women Informed to Screen Depending on Measures of Risk (WISDOM) randomised clinical trial provides compelling evidence for a shift in breast cancer screening strategy. The goal of risk-based screening is to personalize care. Consequently, this allows clinicians to dedicate more resources to high-risk women. It also reduces unnecessary screening in low-risk women. The trial compared an individualised, risk-based approach with the traditional annual screening regimen. This study involved over 28,000 women aged 40 to 74 across the US. For clinicians in India, these findings offer a critical perspective on potential future policy adoption, as current guidelines favour opportunistic annual screening.
Understanding Risk-Based Screening
The WISDOM trial’s risk assessment was comprehensive. Investigators used sequencing of nine key susceptibility genes, a polygenic risk score (PRS), and the Breast Cancer Surveillance Consortium (BCSC) version 2 model to determine a woman’s risk profile. Based on this, the risk-based group received one of four tailored recommendations. Highest-risk women (≥6% 5-year risk) received alternating mammography and magnetic resonance imaging (MRI) every six months. Conversely, the average-risk group was advised to undergo biennial mammography. This strategy directly addresses a core public health principle: resource optimization.
Key Findings: Noninferiority and Acceptability
The primary result established that the risk-based approach was noninferior to annual screening for detecting advanced cancers (Stage IIB or higher). Specifically, the rate was 30 per 100,000 person-years in the risk-based group, compared to 48 per 100,000 person-years in the annual screening group. This indicates the personalised regimen is just as safe as the standard practice for catching clinically significant tumours. Furthermore, biopsy rates did not differ significantly between the two arms of the trial (P=0.10). Importantly, use of risk-reducing medications more than doubled in the highest-risk group. This demonstrates the utility of genetic assessment in promoting preventive uptake. However, some outside groups, including the American College of Radiology, raised concerns about nonadherence and the intense specialist intervention required.
Implications for Indian Breast Cancer Screening Guidelines
The current standard of care in India often recommends opportunistic annual mammography for women aged 40-70 years. Nevertheless, national guidelines also emphasise tailored screening for high-risk women. This tailored screening may include starting annual mammography and MRI earlier, for instance, at age 30. The WISDOM trial strongly supports this tailored approach. It confirms the safety of de-intensifying screening for lower-risk women. Moreover, the trial validates intensified screening for higher-risk women. Consequently, incorporating risk assessment tools like genetic testing and PRS could help India efficiently allocate its limited healthcare resources, especially with the rising breast cancer incidence.
Frequently Asked Questions
Q1: What is the main conclusion of the WISDOM trial?
The trial concluded that a personalised, risk-based breast cancer screening strategy is noninferior, or as safe, as the traditional annual mammography approach for detecting advanced cancers.
Q2: How was individual risk assessed in the risk-based group?
Risk was assessed using a composite profile that included sequencing of nine high-penetrance susceptibility genes, a polygenic risk score (PRS), and the Breast Cancer Surveillance Consortium (BCSC) version 2 model.
Q3: How does the risk-based approach change screening frequency?
Women categorised as highest risk received more intense screening, such as alternating mammography and MRI every six months. Conversely, women deemed average risk were advised to receive biennial mammography, representing a de-intensification of screening.
References
- Esserman LJ et al. Risk-Based vs Annual Breast Cancer Screening: The WISDOM Randomized Clinical Trial. JAMA. 2025 Dec 12. doi: 10.1001/jama.2025.24784. PMID: 41385349.
- Indian Breast Cancer Screening Guidelines. Apollo 247.
- Breast Cancer Screening | Mammogram Recommendations | Early Detection of Breast Cancer. Kauvery Hospital.
- WISDOM Study Finds Personalized Breast Screening Viable For Some Women. Prisma Media.
- Study highlights risk-based breast cancer screening; ACR responds. AuntMinnie.
- Trial Makes the Case for Replacing Annual Breast Cancer Screening. MedPage Today.
- Breast Screening Recommendation from Breast Imaging Society, India. NAMS Annals.