Nine hundred ninety-eight patients with breast cancer were diagnosed between January 1, 1999, and August 31, 2005, and 491 (49%) of them were classified as BI-RADS 5. Overall survival and disease-free survival were estimated with the Kaplan-Meier method and compared across the two groups (BI-RADS 5 versus BI-RADS 0-4) using the log-rank test. Univariate and multivariate analyses were used to identify the prognostic factors.
The median follow-up time was 81.8 months. Kaplan-Meier analysis showed a significant difference between the two subgroups in five-year overall survival (P = 0.001) and five-year disease-free survival (P < 0.0001). On univariate analysis, the mammographic findings (BI-RADS 5 versus BI-RADS 0-4) were statistically significantly associated with five-year overall survival and disease-free survival, as were tumor size, lymph-node status, tumor grade, estrogen-receptor status, progesterone-receptor status, and HER-2 status. On multivariate analysis, only the mammographic findings, lymph-node status, HER-2 status, and tumor grade were significant factors related to five-year overall survival and disease-free survival.
The BI-RADS classification is a reliable prognostic and predictive factor. Patients with BI-RADS 5 breast cancer showed a worse pattern of relapse than that of BI-RADS 0-4 breast cancer patients.