High intensity focused ultrasound: A noninvasive therapy for locally advanced pancreatic cancer

Table 1 Studies of continuous-wave high intensity focused ultrasound treatment for patients with advanced pancreatic cancer

Study	n	Patients	Treatment method	HIFU Device	Outcome and survival	Complications
Wu et al[21]	8	A phase I-II study of HIFU for advanced pancreatic cancer, unresectable. Average tumor size 5.89 cm (4.5-8 cm)	One-session HIFU monotherapy	Continuous HIFU irradiation, Model-JC HIFU System	Pain relief: 8/8 (100%); Median survival: 11.25 mo (2-17 mo)	None
Orsi et al[22]	6	Late-stage pancreatic cancer, unresectable. Average tumor size 4.6 ± 1.4 cm	One-session HIFU monotherapy	Continuous HIFU irradiation, Model-JC HIFU System	Pain relief: 6/6 (100%); Median survival: 7 mo; Overall survival: 42.9% at 12 mo and 21.4% at 24 mo	Portal vein thrombosis: 1/6 (16%)
Wang et al[24]	40	Advanced pancreatic cancer, unresectable. Average tumor size 4.3 cm (2-10 cm)	One-session HIFU monotherapy	Continuous HIFU irradiation, Model-JC HIFU System	Pain relief: 35/40 (87.5%)Median survival: 8 mo (stage III: 10 mo; stage IV: 6 mo); Overall survival: 58.8% at 6 mo and 30.1% at 12 mo	None
Sung et al[25]	46	Advanced pancreatic cancer, unresectable. Average tumor size 4.2 ± 1.4 cm (1.6-9.3 cm)	One-session HIFU monotherapy	Continuous HIFU irradiation, Model-JC HIFU System	A significant reduction of pain score (P < 0.001); Median survival: 12.4 mo; Overall survival: 52.2% at 6 mo, 30.4% at 12 mo, and 21.79% at 18 mo	Mild abdominal pain: 16/46 (34%); severe abdominal pain with vomiting: 2/46 (4%); transient fever: 3/46 (6%); 2nd-3rd skin burns: 2/46 (4%); pancreaticoduodenal fistula: 1/46 (2%),; gastric bleeding due to ulcer: 1/46 (2%)
Wang et al[26]	224	Advanced Pancreatic cancer	One-session HIFU monotherapy	Continuous HIFU irradiation, Model-JC HIFU System	Pain relief and survival data not reported	Abdominal distension, anorexia and nausea: 10/224 (4%); asymptomatic vertebral injury: 2/224 (1%); obstructive jaundice: 1/224 (1%)
Gao et al[27]	39	Locally advanced pancreatic cancer, unresectable. Tumor size unclear	One-session HIFU alone: 14 pts; HIFU + gemcitabine: 25 pts	Continuous HIFU irradiation, Model-JC HIFU System	Pain relief: 31/39 (79.5%) Median survival: 11 mo; Overall survival: 82.1% at 6 mo, and 39.5% at 12 mo	None
Zhao et al[28]	37	A phase II study of HIFU + gemcitabine for locally advanced pancreatic cancer, average tumor size 3.4 cm (1.7-8.5 cm).	Gemcitabine on days 1, 8 and 15, and multiple HIFU sessions on days 1, 3 and 5. The combined treatment repeated every 28 d	Continuous HIFU irradiation, HIFUNIT-9000 HIFU System	Overall survival: 12.6 mo (95%CI: 10.2-15.0); Pain relief: 29/37 (78%)	Fever: 26/37(70%); neutropenia: 6/37 (16%); thrombocytopenia 2/37 (5%); nausea and vomiting 3/37 (8%); diarrhea 2/37 (5%)

HIFU: High intensity focused ultrasound; pts: Patients.