Primary clinical use of sonodynamic therapy (SDT) for advanced breast cancer

12029 Background: There are increasing data showing that sonodynamic therapy (SDT), which refers to a synergistic effect of drugs and ultrasound, is a promising new modality for cancer treatment. Recently a new sonosensitizing agent has been developed by SonneMed, LLC. It is extremely sensitive to ultrasound. As with photodynamic sensitizers, it is specifically absorbed into tumor cells and produces singlet oxygen upon interaction with the right frequency and intensity of ultrasound. The singlet oxygen is able to create cellular necrosis. Our animal studies showed that SDT with SF1 inhibits growth of mouse S-180 sarcoma. Here we report initial clinical data using SDT with SF1 for advanced breast cancer. Methods: Three patients with metastasized pathologically proven breast carcinoma were studied. Their carcinoma failed to respond to conventional therapy and spread to the whole body. The SDT agent was provided through lingual absorption. After 24h, light and ultrasound was applied, irradiating the tumour area for 20 minutes daily for 4 days and repeated every two weeks. Results: Case 1 had breast carcinoma which spread to the whole body. She had surgery, chemo, RT, hormone, Herceptin, Zometa etc, but all failed. The tumor kept growing until she multiple acute symptoms. After 3 SDT treatments her symptom improved significantly and windpipe spile, gastric and urine catheter were all taken off. PET/CT scans showed a positive partial result (PR). Case 2 had left breast carcinoma with multi-organ metastases. After 2 treatments PET/CT scan showed very positive PR. PET/CT taken 28 months after treatment showed no signs of tumor in any cavity of the body. Case 3 had left breast carcinoma. All conventional treatments failed. Her carcinoma metastases broadly and her marrow function was very poor. After 2 cycle treatments PET/CT scan showed PR. Conclusions: Primary clinical data shows that SDT with SF1 is well tolerated and has a significant therapeutic effect for some patients with advanced breast cancer. Even a terminally ill patient can be treated safely and effectively. Sonodynamic therapy with SF1 has significant merit for further investigation. No significant financial relationships to disclose.