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Background <p>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.</p> Methods <p>In this prospective single-center cohort of 80 consecutive women with BI-RADS 3/4a lesions ≤ 30&#xa0;mm undergoing Mammotome<sup>®</sup> VAE, serum cancer antigen (CA)15 − 3, carcinoembryonic antigen (CEA), and CA125 were measured pre-op, 24&#xa0;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.</p> Results <p>Technical success was achieved in 79/80 cases (98.8%, 95% CI: 93.3%–99.9%). Mean procedure time was 18 ± 5&#xa0;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, <i>p</i> = 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, <i>p</i> = 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.</p> Conclusions <p>Mammotome<sup>®</sup> 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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月21日

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  • Yong He,
  • Qiong Sun,
  • Chang Zhou,
  • Rong Liu,
  • Lu-Lu Zou,
  • Hua Chen

摘要

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.