Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma

Abstract

Background: To assess the long term efficacy and tolerability of one or two ultrasound (US)-guided high-intensity focused ultrasound (HIFU) treatment in patients with breast fibroadenoma (FA).

Methods: Twenty patients with 26 FA were selected for US-guided HIFU. The therapy was performed in one or two sessions. FA volume was assessed before and followed up to 24 months after the last HIFU. After each treatment, adverse events were evaluated.

Results: In 19/26 FA (73.1%) one HIFU was performed (group 1), whereas 7/26 FA (26.9%) received second HIFU (group 2) 6-9 months (median, 7 months) after the first session. In group 1 and 2, FA volume decreased significantly at 1-month (p < 0.001) and 3-month follow-up (p = 0.005), respectively, and continued to reduce until 24-month follow-up (p < 0.001 and p = 0.003, respectively). At 24 months, mean volume reduction was 77.32% in group 1 and 90.47% in group 2 (p = 0.025). Mild subcutaneous edema was observed in 4 patients and skin erythema in 3 patients.

Conclusions: US-guided HIFU represents a promising non-invasive method with sustainable FA volume reduction and patient's tolerability. Although one treatment is highly efficient, the volume reduction can be increased with second treatment.

Trial registration: NCT01331954. Registered 07 April 2011.

Keywords: Ablation techniques; Breast fibroadenoma; High-intensity focused ultrasound (HIFU); Interventional ultrasonography; Ultrasound (US) guidance.

Fig. 1

Breast support and immobilization system SenoPad (Theraclion, Paris, France)

Fig. 2

Fibroadenoma volume reduction in patients treated with one HIFU session. *p < 0.001 compared with the initial value before treatment (repeated measures analysis of variance test)

Fig. 3

Radial scan of left breast fibroadenoma in 27-years old woman treated with one HIFU session. a baseline US shows an oval-shaped hypoechoic well-defined lesion of 1.87 ml of volume; b 6 months after the treatment 64.6% of volume reduction was found; c at 12-month follow-up the volume reduction was 73%; d the tendency continued up to 24 months with 78.6% of total volume reduction

Fig. 4

Fibroadenoma volume reduction in patients treated with two HIFU sessions. *p < 0.01 compared with the initial value before treatment (repeated measures analysis of variance test)

Fig. 5

Anti-radial scan of right breast fibroadenoma in 39-years old woman treated with two HIFU sessions. a baseline US shows an oval-shaped hypoechoic well-defined lesion with volume of 10.87 ml; b 6 months after the first HIFU ablation 58.2% of volume reduction was observed, but the FA was still large (4.35 ml); c 6 months after the second HIFU ablation the volume reduction was 96.5% from baseline; d the reduction progressed at 12 months up to 98.7%; e at 24-month follow-up the total volume reduction was 99.1%