High-intensity focused ultrasound for symptomatic breast fibroadenoma

In a case series of 42 women (51 fibroadenomas) treated by high-intensity focused ultrasound (HIFU), 63% (29 out of 46) of the fibroadenomas had reduced in size by 30% at 2 months, 67% (32 out of 48) had reduced by 50% at 6 months and 87% (40 out of 46) had reduced by 60% at 12 months. In a non-randomised controlled study of 40 women, in which 20 were treated by HIFU and 20 were in a control group, fibroadenoma size was statistically significantly reduced by 17% at 2 weeks (standard deviation [SD] 19%, p=0.021) and by 31% at 3 months (SD 53%, p=0.022) in the HIFU group. In the same study, fibroadenoma size reduction was statistically significantly different in women treated by HIFU (44%, SD 39%, p=0.016) compared with women in the control group (5%, SD 46%, p=0.53) at 6‑month follow-up; complete fibroadenoma reduction was reported in 33% (4 out of 20) of women in the HIFU group at 12‑month follow-up. In a case series of 10 patients treated by HIFU, fibroadenoma diameter was reduced by 50% in 100% (10 out of 10) of patients at 3‑month follow-up. In a case series of 9 patients treated by magnetic resonance-guided HIFU, fibroadenomas size was reduced to 1.3 cm³ (mean, SD 1.1 cm³) from a baseline of 1.9 cm³ (mean, SD 1.5 cm³) in 50% (6 out of 12) of treatments at 6‑month follow-up. In a case series of 20 patients, fibroadenoma size was statistically significantly reduced in patients treated only once by HIFU from 0.78 ml (0.35 ml to 2.24 ml) at baseline to 0.35 ml (0.06 ml to 1.21 ml, p<0.001) at 2‑year follow-up, and in patients treated twice from 2.66 ml (0.52 ml to 3.01 ml) to 0.21 ml (0.09 ml to 1.66 ml, p=0.003) at 2‑year follow-up.

In the non-randomised controlled study of 40 women, 10% (2 out of 20) of fibroadenomas treated by HIFU did not change in size at 6‑month follow-up.

In the case series of 9 patients treated by magnetic resonance-guided HIFU, technical failure was reported in 42% (5 out of 12) of fibroadenoma treatments.

In the case series of 42 women, 61% (31 out of 51) of the fibroadenomas had caused discomfort before the procedure, which had resolved in 100% of the women at 12‑month follow-up. In the same study, at baseline, 35% (18 out of 51) of fibroadenomas were associated with pain, which had resolved in 100% of patients at 12‑month follow-up. In the non-randomised controlled study of 40 women, complete pain reduction was reported by 75% (6 out of 8) of women treated by HIFU at 6‑month follow-up.

In the case series of 20 patients treated by HIFU, for symptom disappearance, 45% (9 out of 20) of patients were completely satisfied, and satisfaction was high in 50% (10 out of 20) and low in 5% (1 out of 20) of patients. In the same case series, for cosmetic results, 95% (19 out of 20) of patients were completely satisfied and satisfaction was high in 5% (1 out of 20) of patients.

The specialist advisers listed key efficacy outcomes as reduction in lesion size, relief or resolution of symptoms, cost effectiveness, recurrence of symptoms in the short and long term, and time taken to do the procedure.