# Clinical outcomes of ultrasound-guided mammotome vacuum-assisted excision for benign breast tumors and its impact on serum tumor markers

## TL;DR

This study shows that ultrasound-guided vacuum-assisted excision for benign breast tumors is effective and does not raise cancer-related blood markers in the short term.

## Contribution

The study provides new evidence that VAE does not increase serum tumor markers like CA15-3, CEA, or CA125 up to 3 months post-procedure.

## Key findings

- Technical success rate was 98.8% with minimal complications.
- No significant increase in CA15-3, CEA, or CA125 was observed at 3 months.
- Lesion volume reduced by 93% and patient satisfaction was high at 3 months.

## Abstract

Ultrasound-guided vacuum-assisted excision (VAE) is widely used for benign breast lesions, but its systemic impact is unclear. We tested whether VAE increases serum CA15-3 at 3 months and described clinical outcomes.

In this prospective single-center cohort of 80 consecutive women with BI-RADS 3/4a lesions ≤ 30 mm undergoing Mammotome® VAE, serum cancer antigen (CA)15 − 3, carcinoembryonic antigen (CEA), and CA125 were measured pre-op, 24 h, 1 month, and 3 months. Outcomes included technical success, 30-day complications, BREAST-Q satisfaction (1/3 months), 1-month lesion-volume change, and 12-month local recurrence. Primary endpoint: paired CA15-3 change at 3 months; noninferiority margin + 2 U/mL.

Technical success was achieved in 79/80 cases (98.8%, 95% CI: 93.3%–99.9%). Mean procedure time was 18 ± 5 min; Clavien-Dindo I–II complications occurred in seven patients (8.8%). Baseline CA 15 − 3 was 12.0 ± 4.0 U/mL and 11.7 ± 3.8 U/mL at 3 months (mean Δ − 0.3 U/mL, 95% CI: − 0.8 to 0.2, p = 0.24), satisfying the predefined non-inferiority margin. CEA and CA 125 likewise showed no clinically relevant change; the slight CA 125 decline (–1.0 U/mL, p = 0.040) lost significance after Bonferroni correction. Lesion-volume reduction at 1 month averaged 93% ± 6%, and BREAST-Q satisfaction at 3 months was 90 ± 7. One local recurrence (1.4%) was detected during 12-month surveillance.

Mammotome® VAE achieved high technical success, low morbidity, excellent cosmesis, and no increase in serum CA15-3, CEA, or CA125 through 3 months. Twelve-month local control was favorable. Longer follow-up and multicenter studies with broader biologic measures are needed to confirm long-term systemic neutrality and external validity.

The online version contains supplementary material available at 10.1186/s12893-025-03293-x.