Objective: To assess the agreement between Quantra™ (Hologic Inc., Bedford, MA) and Breast Imaging Reporting and Data Systems (BI-RADS®) and the performance of Quantra at reproducing BI-RADS mammographic breast density (MBD) assessment. Methods: MBD assessment was performed using Quantra and BI-RADS. BI-RADS assessment was performed in two phases (1314 and 292 cases, respectively). Kappa was used to assess the interreader agreement and the agreement between Quantra and BI-RADS, and receiver-operating characteristics analysis was used to assess the performance of Quantra at reproducing BI-RADS rating. In Phase 1, Quantra demonstrated 93.2% sensitivity and 86.1% specificity for BI-RADS on a two-grade scale (1-2 vs 3-4). In Phase 2, it demonstrated 91.3% sensitivity and 83.6% specificity on a two-grade scale. Conclusion: Quantra is limited in reproducing BI-RADS rating on a four-grade scale; however, it highly reproduces BI-RADS assessment on a two-grade scale. Advances in knowledge: Quantra (v. 2.0) is a poor predictor of BI-RADS assessment on a four-grade scale, but well reproduces BI-RADS rating on a two-grade scale. Therefore, it should be considered a tool for two-grade scale MBD classification.
INTRODUCTIONBreast density is associated with breast cancer risk, interval breast cancer and mammographic sensitivity. 1,2 It has been shown that 30% reduction in breast cancer mortality is partly attributable to improved knowledge of its risk factors and advances in early detection and treatment strategies. 3,4 Breast density refers to the proportion of the breast that is composed of fibroglandular tissue 5 and is related to established breast cancer risk factors such as genetics, hormonal agents and lifestyle characteristics. 6,7 Most importantly, breast density reduction has been shown to be a prognostic marker of response to adjuvant tamoxifen therapy in post-menopausal females. 8,9 Therefore, adding breast density information to existing breast cancer riskprediction models may improve the stratification of breast cancer risk, 10 which may lead to earlier adoption of prevention and control measures. Breast density information can also be used for tailoring clinical decisions such as screening intervals for females who are asymptomatic and the selection of more appropriate imaging pathways such