Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions (PROCEM): A Randomized Controlled Trial.
Anna Gardfjell, Lisa Rydén, Emma Niméus et al.
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In 30 seconds
This prospective, multicenter randomized controlled trial evaluated whether preoperative contrast-enhanced mammography (CEM) adds value to standard imaging for staging early-stage breast cancer in women eligible for primary surgery. Among 415 participants, CEM findings changed treatment in 17 of 202 women (8.4%; 95% CI: 5.3, 13.1), below the prespecified 10% primary endpoint. Mastectomy and reoperation rates did not differ between groups. CEM estimates of malignant extent agreed most closely with histopathology, with a bias of 3.5 mm, compared with 4.8 mm for mammography and/or tomosynthesis and 10.7 mm for US.
Key findings
- CEM changed treatment in 17 of 202 participants (8.4%; 95% CI: 5.3, 13.1), not reaching the 10% primary endpoint.
- Mastectomy rates were 17% [35 of 202] with CEM and 18% [39 of 213] with control (P = .78).
- Reoperation rates were 7.9% [16 of 202] with CEM and 10% [22 of 213] with control (P = .39).
- Extent-estimation bias was 3.5 mm for CEM, 4.8 mm for mammography and/or tomosynthesis, and 10.7 mm for US.
Why it matters
Preoperative imaging estimates of malignant extent can inform surgical planning. This trial suggests CEM may provide a closer estimate of histopathologic extent than conventional imaging, while showing no evidence of lower mastectomy or reoperation rates. The distinction is clinically relevant: improved measurement accuracy did not translate into demonstrated differences in these surgical outcomes in this study.
What to keep in mind
The trial enrolled women with early-stage breast cancer eligible for primary surgery at two Swedish breast centers, limiting direct generalization to other populations and settings.