“We need to carefully evaluate the treatment parameters to determine whether to design a clinical trial based on this case,” said Theraclion CEO David Caumartin. “Theraclion is dedicated to solving complex medical problems, and breast cancer treatment is a natural progression from our successful breast fibroadenoma application.”In the reported patient, physicians applied local anesthesia, cooled the skin to 12 to 14 ℃, and then raised the ablation temperature in the target region to 80 ℃ during treatment. The tumor was visualized using ultrasound guidance, and the team noted that it became hyperechoic during the ablation.
See High Focused Ultrasound in a Case of Previously Untreated Breast Cancer in Clinical Medical Reviews and Case Reports >
Although the Model JC system manufactured by Chongqing Haifu has been approved in Europe, Russia, and China for the treatment of breast cancer, clinical trials are still underway for other systems around the world. Learn more about the sytems and locations on the Focused Ultrasound Foundation website >
To learn more about this specific case, the scientific team at Theraclion interviewed one of the authors, Dr. Hans Christian Kolberg from Marienhospital Bottrop:
Could you please tell us more about the case described in your report?This 48-year-old female patient was diagnosed 17 months earlier with node positive, hormone-receptor positive, HER2-negative breast cancer. She refused, despite contrary advice, all state-of-the-art treatment, but specifically requested high-intensity focused ultrasound (HIFU) treatment. Because this was a last resort alternative for her and after repeatedly recommending state-of-the-art treatment and discussing the case in our interdisciplinary breast tumor boards, we decided to perform the treatment. Because the patient refused any standard medical therapy (especially endocrine therapy or surgery) the treatment was performed without any other adjuvant pharmaceutical or device concomitant methods.
How did the patient react to the treatment?
A: Ten months after the HIFU treatment, the breast tumor showed a complete remission by ultrasound assessment and the involved axillary lymph node showed a more than 50% reduction in size.
What does this mean?
We are remaining very cautious, as this is the interpretation of a single case, but the substantial shrinkage of the untreated involved axillary lymph node suggests a systemic - possibly immunologic - effect originating from the local therapy of the primary HIFU treated tumor. This will need further investigation in prospective trials, optimally in combination with immune therapies.