TABLE 3:
Summary of Comparative Impact of Supplemental Screening Beyond 2D Mammography for Women With Dense Breasts and Surrogate Endpoint Validation
| Screening Modality | No. of Patients | Incremental CDRa | Incremental Invasive CDRa | Node-Negative Invasive Cancers, %b | Incremental Recall Ratea | Reduced Interval Cancers | Reduced Late-Stage Disease |
|---|---|---|---|---|---|---|---|
| DBT | 103,245c | 1.7c | 1.4d | Not evaluated | −20c | No | Not evaluated |
| US | 452,743e | 2.0–2.7e | 1.8–2.3e | 88.6 (635/717) | 76–106 | Yes | Not evaluated |
| MBIf | 4277 | 8.1 | 6.2 | 85 (23/27) | 67 | Not yet evaluated | Not yet evaluated |
| MRI | 9256g | 16.0 | 12.1 | 88 (99/112) | 104 | Yes | Yesh |
| MRI after DBT | 1444i | 9.7 | 6.9 | 94 (16/17) | 215 | Not yet evaluated | |
| CEM | 1311j | 10.7 | 8.4 | 75 (6/8) | 150j | Not yet evaluated | Not yet evaluated |
Note—CDR = cancer detection rate, DBT = digital breast tomosynthesis, US = ultrasound, MBI = molecular breast imaging, CEM = contrast-enhanced mammography.
Per 1000 women screened.
Data in parentheses are number of invasive breast cancers staged that were node negative/total number of invasive breast cancers seen only on that modality.
The CDR of DBT was 682 cancers detected among 103,245 women (6.61 cancers detected per 1000 women screened) across the four studies presented in Table 1 [13, 35, 42, 43] versus 876 cancers detected among 176,986 women (4.95 cancers detected per 1000 women screened) for 2D mammography, for a difference of 1.7 cancers detected per 1000 women screened; there were 12,280 recalls per 113,986 DBT examinations (10.8%) versus 23,727 recalls per 185,763 2D examinations (12.8%), for a difference of 2.0% or 20 recalls per 1000 examinations.
Data are from [43] only; incremental invasive CDR data were not reported in the other studies.
As summarized in Berg et al. [52], results are from 361,562 US examinations performed by physicians, 64,018 US examinations performed by technologists, and 27,163 automated screening US examinations, with an average incremental CDR of 2.0 cancers (88% of which were invasive cancers) per 1000 women screened for handheld US performed by a physician and 2.7 cancers (86% of which were invasive cancers) per 1000 women screened for US performed by a technologist, and 2.5 cancers (91% of which were invasive cancers) per 1000 women screened for automated US.
Data from three series [65, 66, 100] limited to women with dense breasts on prior or current mammogram.
Data from three of the series [54, 81, 82] summarized in Table 2. In Kuhl et al. [81], the incremental CDR for prevalence screening versus incidence screening was 22.6 cancers per 1000 women screened versus 6.9 cancers per 1000 women screened, respectively. Other findings are for prevalence screening.
Reduced late-stage disease has been shown only for women with known pathogenic BRCA1 or BRCA2 mutations screened using MRI [74].
Prevalence screening with abbreviated MRI compared with tomosynthesis [87], as described in Table 2.
Data are from two series [95, 96]. Cancer findings are shown for the 700 women with dense breasts in the series evaluated by Sung et al. [96], whereas recall rates include false-positive and true-positive recalls for all 904 women because results were not distinguished for the subset of women with dense breasts.