Key Points
- Follow-up data from a clinical trial evaluating the efficacy of high-intensity focused ultrasound (HIFU) for treating benign breast tumors have been published.
- A single HIFU treatment significantly reduced the size of the tumors and the associated symptoms, with benefits persisting over five years.
Long-term results from a clinical trial conducted at the University Hospital of Tübingen, Germany, in the breast surgery department under the leadership of Professor Markus Hahn, MD, demonstrated that a single HIFU treatment substantially reduced the size and symptoms of breast fibroadenomas, and the effects lasted more than five years. Published in Scientific Reports, the paper emphasizes the long-term effectiveness of HIFU therapy while noting that incomplete treatment can result in tissue regrowth.
Breast fibroadenomas are non-cancerous tumors that affect 1 in 4 women, usually between the ages of 15 and 35. The majority of fibroadenomas will grow or remain stable and can cause pain and increasing anxiety over time. HIFU is a noninvasive treatment option for women living with symptomatic fibroadenomas. This is the first study to publish five-year follow-up data on HIFU therapy for this condition.
Twenty-seven women diagnosed with fibroadenomas received a single HIFU ablation, or echotherapy treatment, with Theraclion’s EchoPulse device from December 2013 through November 2014. The treated fibroadenomas were evaluated at regular intervals over a five-year period using ultrasound imaging and palpation. Participant discomfort was also assessed at each time point.
The echotherapy HIFU treatment shrunk the fibroadenomas by 85% within 12 months and by 92% after 5 years, and less than 8% were palpable after 2 years. Pain levels followed a similar pattern, dropping rapidly over the first year and remaining stable for the next four years. One participant, whose fibroadenoma was only partially ablated, experienced regrowth three years post-HIFU, underscoring the importance of thorough treatment.
“For the first time, this study demonstrates the long-term efficacy of echotherapy HIFU for fibroadenoma,” said Michel Nuta, MD, Theraclion’s chief medical officer. “HIFU offers a scar-free, outpatient alternative to surgery while providing the same benefits.”
Patients in Europe with fibroadenomas can locate treatment centers on Theraclion’s website.
A multi-center pivotal clinical trial using HIFU echotherapy to treat breast fibroadenomas is ongoing in the United States. Researchers are also exploring the use of the EchoPulse system to treat breast cancer by combining it with immunotherapy.
Read “Five-year follow-up after a single US-guided high intensity focused ultrasound treatment of breast fibroadenoma” in Scientific Reports (open source).
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