Purpose: To evaluate the efficacy of extracorporeal ultrasound-guided high intensity focused ultrasound (HIFU) based upon data in controlled clinical trials in China.
Materials and methods: Data in 75 controlled trials involving in 833 cases of benign and 4559 cases of malignant diseases were re-evaluated.
Results: In uterine fibroid, ectopic pregnancy and chyluria, the efficacy of HIFU was similar to that of surgery or drugs. The survival rate of HIFU plus radiotherapy was less than that of radical surgery in operable liver cancer. In inoperable liver cancer, the survival benefit of HIFU was similar to that of radio frequency, transarterial chemoembolization or γ-knife. In pancreatic cancer, HIFU and chemotherapy produced similar survival rates, and HIFU did not improve the effect of chemotherapy or radiotherapy. HIFU did not enhance hormone therapy in prostate cancer. Preoperative HIFU increased rates of complete removal and of survival in retroperitoneal sarcoma, and increased the response rate in breast cancer. The response rate agreed with the survival benefit (κ = 0.71, p = 0.0002).
Conclusions: HIFU should be curtailed in resectable cases and be an alternative in inoperable cases; a combination regimen should not be recommended. The Response Evaluation Criteria in Solid Tumors can be applied to HIFU.
Keywords: Ultrasound-guided high intensity focused ultrasound (HIFU); benign disease; cancer; clinical benefit.