High Intensity Focused Ultrasound Therapy In Combination With Gemcitabine For Unresectable Pancreatic Carcinoma

Background: Pancreatic carcinoma is one of the most common malignant tumors of digestive system which contains 1%~2% of common malignant tumors. The prevalence of pancreatic carcinoma has dramatically increased over the past decades. The prognosis is very poor. The 5-year survival rate is less than 5% and median survival time (MST) of late-stage patients is only 4~6months. It is very difficult to diagnose pancreatic cancer in the early stage, and more than 80% patients are at late stage when diagnosed. Chemotherapy is the major treatment for unresectable pancreatic carcinoma, and gemcitabine (GEM) has been formally approved for the first-line treatment of advanced pancreatic cancer by FDA. High-intensity focused ultrasound (HIFU) is a new palliative physical method for tumor which provides a effective and safe choice for pancreatic cancer. GEM and HIFU can both increase the survival time, survival rate and disease control rate and improve life quality. HIFU is much better than GEM in the clinical benefit rate, and the rate of adverse effect is low. But the curative effect of HIFU and GEM is not perfect.Purpose: Analysis retrospectively the MST, 6-month and 12-month survival rate, DCR, CBR and the adverse effect of HIFU group, GEM group, and HIFU-GEM group, and compare the clinical curative effect, and select the best treatment for unresectable pancreatic carcinoma.Methods: Systematicly review the clinical case of 84 unresectable pancreatic carcinoma patients diagnosed by pathology and/or clinical manifestation. There are 20 cases in HIFU group, the output power of FEP-BY02 high-intensity focused ultrasound tumor therapy equipment is 0.5～2kW, effective therapy depth is 4～15cm, a firing system located in a tank filled with degassed water, treated 3～10 times, the average is 5 times. There are 20 cases in GEM group, treated with GEM (1000mg/m2) alone weekly for 7weeks followed by a 2-week rest, then received cycles of 3-week administration with 1-week rest. There are 28 cases in HIFU-GEM group, the treatment of HIFU is the same as HIFU group and the treatment of GEM is the same as GEM group, and start HIFU at the first day of GEM. SPSS 13.5 statistical software was used for processing data. The MST, 6-month and 12-month survival rates were calculated by Kaplan-Meier method. Clinical benefit response (CBR) and toxicity were also assessed.Results: (1) CBR: CBR of HIFU group, GEM group and HIFU-GEM group were 61.1%, 30.0% and 83.3% respectively, p<0.05. CBR of HIFU-GEM group is higher than GEM and HIFU group, p<0.05, CBR of HIFU is higher than GEM group, p< 0.05. (2) DCR: DCR of HIFU group, GEM group and HIFU-GEM group were 72.2%, 60.0%, and 82.1% respectively, p>0.05. (3) OS: MST, 6-month and 12-month survival rates of HIFU group were 7.9 months, 58.2% and 19.1%; MST, 6-month and 12-month survival rates of GEM group were 6.4 months, 52.3% and 17.3%; MST, 6-month and 12-month survival rates of HIFU-GEM group were 10.04 months, 73.8% and 35.2%; HIFU-GEM group is higher than GEM and HIFU group, p<0.05, but between HIFU group and GEM group, p< 0.05. (4) adverse effect: there was no important complication such as organ perforated, bleeding, the pancreas fistulae, biliary fistulae, pancreatitis or peritonitis. 35 cases had abdominal pain during treatment, and released after treatment. 12 cases had abdominal pain after treatment, giving no drugs, and released after 3 days. 3 cases had skin burn of I grade, giving no treatment. 5 cases had fever( 37.7~38.5℃),back to normal body temperature by physical method in 3 days. The rate of leucopenia, thrombocytopenia and anemia( III~IV) in GEM group were 15.0%, 20.0%, 10.0%, the rate of leucopenia, thrombocytopenia and anemia( III~IV) in HIFU- GEM group were 10.7%, 17.9%, 7.1%, p<0.05.Conclusion: MST, 6-month and 12-month survival rates and CBR of HIFU-GEM group is higher than GEM and HIFU group, and CBR of HIFU group is higher than GEM group.There is no difference between the adverse effect of HIFUgroup, GEMgroup and HIFU-GEM group. So HIFU in combination with GEM is supposed to an effective and safe therapy for unresectable pancreatic carcinoma.