Is Risk-based Screening Justified by the WISDOM Trial?

Area of Science:

• Oncology
• Radiology
• Preventive Medicine

Background:

• Widespread mammography screening reduces breast cancer mortality but is resource-intensive.
• The WISDOM trial evaluated risk-based screening as an alternative to annual age-based screening.
• Previous reports suggested risk-based screening was safe and acceptable.

Purpose of the Study:

• To critically assess the safety and acceptability of the WISDOM trial's risk-based breast cancer screening approach.
• To evaluate the validity of the trial's conclusions regarding noninferiority and reduced biopsies.

Main Methods:

• Analysis of the WISDOM trial's primary endpoints, focusing on stage IIB+ breast cancers and biopsy rates.
• Examination of mammography and MRI compliance data within the trial's screening arms.
• Critique of the noninferiority margin and study design for comparing screening strategies.

Main Results:

• The study's primary endpoint for noninferiority was compromised by the chosen metric and weak margin.
• Significant non-compliance with screening protocols in both risk-based and age-based arms was observed.
• The secondary endpoint aiming to show fewer biopsies with risk-based screening was not met.

Conclusions:

• The WISDOM trial results do not support the conclusion that risk-based screening is safe or acceptable.
• Poor compliance and design flaws limit the ability to compare screening strategies effectively.
• Risk-based screening is labor-intensive, challenging to implement, and may miss cancers in average-risk, younger, or minority women.