Extracorporeal high intensity focused ultrasound treatment for patients with breast cancer.
OBJECTIVE
To investigate the safety, efficacy and feasibility of using high-intensity focused ultrasound (HIFU) as a non-invasive treatment for patients with breast cancer.


METHODS
Twenty-two patients with breast cancer were enrolled into this non-randomized prospective trial. Disease TNM stage was classified as stage I in 4 patients, stage II(A) in 9 patients, stage II(B) in 8 patients, and stage IV in 1 patient. Tumor size ranged from 2 to 4.8 cm in diameter (mean 3.4 cm). All patients received chemotherapy, radiation and tamoxifen, following HIFU for the primary lesions. Outcome measures included radiological and pathologic assessment of the treated tumor, cosmesis, and local recurrence. A cumulative survival rate is calculated by using the Kaplan-Meier method.


RESULTS
No severe complications were encountered after HIFU. Post-operative imaging demonstrated positive response and regression of all treated lesions. Follow-up biopsy revealed coagulation necrosis of target tumor and subsequent replacement 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 patients.


CONCLUSIONS
HIFU treatment is safe, effective, and feasible for patients with breast cancer. But, large-scale, multiple-center clinical trials will be needed to determine the future role of this novel modality.
Wu
Feng
F
Institute of Ultrasonic Engineering in Medicine, Chongqing University of Medical Sciences, Box 153, 1 Medical College Road, Chongqing 400016, China. mfengwu@yahoo.com
Wang
Zhi-Biao
ZB
Zhu
Hui
H
Chen
Wen-Zhi
WZ
Zou
Jian-Zhong
JZ
Bai
Jin
J
Li
Ke-Quan
KQ
Jin
Cheng-Bing
CB
Xie
Fang-Lin
FL
Su
Hai-Bing
HB
D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011446:Prospective Studies; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods*; D014463:Ultrasonography