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

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.