Agreement between digital breast tomosynthesis and pathologic tumour size for staging breast cancer, and comparison with standard mammography

Abstract Purpose Tomosynthesis is proposed to improve breast cancer assessment and staging. We compared tomosynthesis and mammography in estimating the size of newly-diagnosed breast cancers. Methods All pathologically-confirmed cancers detected in the STORM-2 trial (90 cancers, 85 women) were retrospectively measured on tomosynthesis by two independent readers. One reader also measured cancers on mammography. Relative mean differences (MDs) and 95% limits of agreement (LOA) with pathology were estimated for tomosynthesis and mammography within a single reader (Analysis 1) and between two readers (Analysis 2). Results Where cancers were detected and hence measured by both tests, tomosynthesis overestimated pathologic size relative to mammography (Analysis 1: MD 5% versus 1%, Analysis 2: 7% versus 3%; P  = 0.10 both analyses). There was similar, large measurement variability for both tests (LOA range: −60% to +166%). Overestimation by tomosynthesis was attributable to the subgroup with dense breasts (MDs = 12–13% versus 4% for mammography). There was low average bias for both tests in the low-density subgroup (MDs = 0–4%). LOA were larger in dense breasts for both tomosynthesis and mammography ( P  ≤ 0.02 all comparisons). Cancers detected only by tomosynthesis were more frequently in dense breasts (60–68%): for those tumours size was estimated with increased measurement variability (LOA ranging from −75% to +293%). Conclusions On average, tomosynthesis overestimates pathologic tumour size in women with dense breasts; that difference is more likely to impact management in women with larger tumours. The main advantage of tomosynthesis appears to be detecting mammographically-occult cancers; however tomosynthesis less accurately measured those cancers in dense breasts (large measurement variability).