title: Concurrent gemcitabine and high-intensity focused ultrasound therapy in patients with locally advanced pancreatic cancer.
abstract: This phase II trial was conducted to evaluate the safety and efficacy of concurrent gemcitabine and high-intensity focused ultrasound (HIFU) therapy in patients with locally advanced pancreatic cancer. Patients with localized unresectable pancreatic adenocarcinoma in the head or body of the pancreas received gemcitabine (1000 mg/m) intravenously over 30 min on days 1, 8, and 15, and concurrent HIFU therapy on days 1, 3, and 5. The treatment was given every 28 days. Thirty-seven (94.9%) of the 39 patients were assessable for response, and two cases of complete response and 15 cases of partial response were confirmed, giving an overall response rate of 43.6% [95% confidence interval (CI), 28.0-59.2%]. The median follow-up period was 16.5 months (range: 8.0-28.5 months). The median time to progression and overall survival for all patients were 8.4 months (95% CI, 5.4-11.2 months) and 12.6 months (95% CI, 10.2-15.0 months), respectively. The estimates of overall survival at 12 and 24 months were 50.6% (95% CI, 36.7-64.5%) and 17.1% (95%CI, 5.9-28.3%), respectively. A total of 16.2% of patients experienced grade 3/4 neutropenia. Grade 3 thrombocytopaenia was documented in two (5.4%) patients. Grade 3 nausea/vomiting and diarrhea were observed in three (8.1%), and two (5.4%) patients, respectively. Grade 1 or 2 fever was detected in 70.3% of patients. Twenty-eight patients (71.8%) complained of abdominal pain consistent with tumor-related pain before HIFU therapy. Pain was relieved in 22 patients (78.6%). In conclusion, concurrent gemcitabine and HIFU is a tolerated treatment modality with promising activity in patients with previously untreated locally advanced pancreatic cancer.
authors.affiliation: Clinical HIFU Therapy Center, Huadong Hospital affiliated to Fudan University, No. 221 West Yan'an Road, Shanghai, People's Republic of China. drhong.zhao.md@gmail.com
authors.forename: Hong
authors.initials: H
authors.lastname: Zhao
authors.forename: Guowang
authors.initials: G
authors.lastname: Yang
authors.forename: Daoyuan
authors.initials: D
authors.lastname: Wang
authors.forename: Xiangrong
authors.initials: X
authors.lastname: Yu
authors.forename: Yu
authors.initials: Y
authors.lastname: Zhang
authors.forename: Junqiu
authors.initials: J
authors.lastname: Zhu
authors.forename: Yongle
authors.initials: Y
authors.lastname: Ji
authors.forename: Baoliang
authors.initials: B
authors.lastname: Zhong
authors.forename: Wenshuo
authors.initials: W
authors.lastname: Zhao
authors.forename: Zhong
authors.initials: Z
authors.lastname: Yang
authors.forename: Fahad
authors.initials: F
authors.lastname: Aziz
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine