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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.