title: A novel approach to brachytherapy in hepatocellular carcinoma using a phosphorous32 (32P) brachytherapy delivery device--a first-in-man study.
abstract: OBJECTIVE
  While potentially very useful, percutaneously delivered brachytherapy of inoperable intra-abdominal solid tumors faces significant technical challenges. This first-in-man study is designed to determine the safety profile and therapeutic efficacy of a novel phosphorous (32P) brachytherapy device (BrachySil) in patients with unresectable hepatocellular carcinoma.
  
  
  METHODS
  Patients received single percutaneous and transperitoneal implantations of BrachySil under local anesthesia directly into liver tumors under ultrasound or computed tomographic guidance, at an activity level of 4 MBq/cc of tumor. Toxicity was assessed by the nature, incidence, and severity of adverse events (Common Toxicity Criteria scores) and by hematology and clinical chemistry parameters. Target tumor response was assessed with computed tomographic scans at 12 and 24 weeks postimplantation using World Health Organization criteria.
  
  
  RESULTS
  Implantations were successfully carried out in 8 patients (13-74 MBq, mean 40 MBq per tumor) awake and under local anesthesia. Six of the 8 patients reported 19 adverse events, but no serious events were attributable to the study device. Changes in hematology and clinical chemistry were similarly minimal and reflected progressive underlying hepatic disease. All targeted tumors were responding at 12 weeks, with complete response (100% regression) in three lesions. At the end of the study, there were two complete responses, two partial responses, three stable diseases, and one progressive disease.
  
  
  CONCLUSIONS
  Percutaneous implantation of this novel 32P brachytherapy device into hepatocellular carcinoma is safe and well tolerated. A significant degree of antitumor efficacy was demonstrated at this low dose that warrants further investigation.
authors.affiliation: Department of Nuclear Medicine, Singapore General Hospital, Singapore.
authors.forename: Anthony Soon-Whatt
authors.initials: AS
authors.lastname: Goh
authors.forename: Alexander Yaw-Fui
authors.initials: AY
authors.lastname: Chung
authors.forename: Richard Houa-Gong
authors.initials: RH
authors.lastname: Lo
authors.forename: Te-Neng
authors.initials: TN
authors.lastname: Lau
authors.forename: Sidney Wing-Kwong
authors.initials: SW
authors.lastname: Yu
authors.forename: May
authors.initials: M
authors.lastname: Chng
authors.forename: Somanesan
authors.initials: S
authors.lastname: Satchithanantham
authors.forename: Susan Li-Er
authors.initials: SL
authors.lastname: Loong
authors.forename: David Chee-Eng
authors.initials: DC
authors.lastname: Ng
authors.forename: Beng-Choo
authors.initials: BC
authors.lastname: Lim
authors.forename: Stephen
authors.initials: S
authors.lastname: Connor
authors.forename: Pierce Kah-Hoe
authors.initials: PK
authors.lastname: Chow
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006528:Carcinoma, Hepatocellular / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D010761:Phosphorus Radioisotopes / Q000627:therapeutic use*; D015641:Radiography, Interventional; D011879:Radiotherapy Dosage; D017655:Silicon Compounds / Q000008:administration & dosage; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D010761:Phosphorus Radioisotopes; D017655:Silicon Compounds