Feng Wu MD, PhD, Presenter: Nothing to Disclose

Zhi-Biao Wang MD,PhD, Abstract Co-Author: Nothing to Disclose

Hui Zhu MS, Abstract Co-Author: Nothing to Disclose

Wenzhi Chen MD, Abstract Co-Author: Nothing to Disclose

Jian-Zhong Zou MD, Abstract Co-Author: Nothing to Disclose

Jin Bai MD, Abstract Co-Author: Nothing to Disclose

Ke-Quan Li, Abstract Co-Author: Nothing to Disclose

Cheng-Bing Jin, Abstract Co-Author: Nothing to Disclose

Fang-Lin Xie MD, Abstract Co-Author: Nothing to Disclose

Hai-Bing Su, Abstract Co-Author: Nothing to Disclose

et al, Abstract Co-Author: Nothing to Disclose

High intensity focused ultrasound (HIFU) is a noninvasive ablative technique for the treatment of solid malignancies. The current study was to explore the safety, efficacy, and feasibility of ultrasound-guided HIFU in the treatment of patients with breast cancer.

From March 1998 to April 2001, 45 patients with biopsy-proven breast cancer were enrolled in phase II and phase III clinical trials. In the phase II trial 23 patients (TNM staging: I in 2 and II in 21) underwent HIFU ablation prior to surgical resection for pathologic study. The remaining 22 patients (TNM staging: I in 4, II in 17, and IV in 1) received HIFU treatment combined with chemotherapy, radiation and tamoxifen in the phase III trial. They were followed up to observe long-term efficacy. Tumor size ranged from 2 to 4.8 cm. Pathological examinations were performed in the phase II trial, and in the phase III trial outcome measures included radiological and pathologic assessment of the treated tumor, cosmesis, and local recurrence. A cumulative survival rate was calculated by using the Kaplan-Meier method.

No severe side effects were observed in all patients treated with HIFU. Pathological examination showed that HIFU induced coagulation necrosis of targeted lesion including a tumor and 1.5-2 cm surrounding normal mammary tissue. Small vascular vessels were severely damaged. Post-procedural radiological images revealed absence of tumor vascular supply and the regression of treated lesions. Follow-up biopsy revealed the subsequent replacement of treated tumor by fibroblastic tissue. After a median follow-up of 54.8 months, 1 patient died, 1 was lost to follow-up, and 20 were still alive. Two of 22 patients developed local recurrence. Five-year disease-free survival and recurrence-free survival were 95% and 89%, respectively. Cosmetic result was judged as good to excellent in 94% of 24 patients.

Ultrasound-guided HIFU treatment is safe, effective, and feasible for patients with breast cancer.

F.W.,Z.W.,W.C.,J. .,J.B.: Financial interest of all authors is detailed below: Dr. Feng Wu is a shareholder in the Chongqing Haifu Technology Limited Company and a consultant to the same; Dr. Zhi-Biao Wang is a shareholder in the Chongqing Haifu Technology Limited Company and is a full-time employee of the same. Dr. Wen-Zhi Chen is a shareholder in the Chongqing Haifu Technology Limited Company and is a consultant to the same. Dr. Jian-Zhong Zou is a shareholder in the Chongqing Haifu Technology Limited Company and is a consultant to the same. Dr. Jin Bai is a shareholder in the Chongqing Haifu Technology Limited Company and is a consultant to the same.

Wu, F, Wang, Z, Zhu, H, Chen, W, Zou, J, Bai, J, Li, K, Jin, C, Xie, , Su, , et al, , Clinical Phase II and Phase III Trials Using High Intensity Focused Ultrasound Treatment for Patients with Breast Cancer.  Radiological Society of North America 2005 Scientific Assembly and Annual Meeting, November 27 - December 2, 2005 ,Chicago IL. http://archive.rsna.org/2005/4408529.html