title: Safety and long term efficacy of porfimer sodium photodynamic therapy in locally advanced biliary tract carcinoma.
abstract: BACKGROUND
  In patients with unresectable cholangiocarcinoma, photodynamic therapy (PDT) with porfimer sodium promotes biliary drainage and may improve survival and quality of life.
  
  
  OBJECTIVE
  To prospectively evaluate the safety and efficacy of PDT in patients with locally advanced biliary tract carcinoma.
  
  
  METHODS
  Eligible patients had unresectable, histologically confirmed disease, a Karnofsky performance status of ≥30% and life expectancy >12 weeks. Patients received 2mg/kg i.v. of porfimer sodium, followed by endobiliary laser activation and stent replacement 48 h later. Patients were assessed clinically and radiologically before treatment and on day 28, and followed up thereafter at three-monthly intervals until death.
  
  
  RESULTS
  36 patients were entered over an 18 months period: 14 males, 22 females, with a median age of 65 (30-79)yr and performance status of 80 (50-100). PDT was technically successful in all cases and was generally well tolerated; there was no grade 4 toxicity and no treatment-associated mortality. The median survival was 12 (1-84) months.
  
  
  CONCLUSIONS
  Porfimer sodium PDT can be delivered safely to patients with biliary tract cancer and is suitable for testing in phase III studies (UKCRN ID 1218).
authors.affiliation: UCL Institute of Liver and Digestive Health, University College London, UK. stephen.pereira@ucl.ac.uk
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Pereira
authors.forename: Guruprasad P
authors.initials: GP
authors.lastname: Aithal
authors.forename: Krish
authors.initials: K
authors.lastname: Ragunath
authors.forename: John
authors.initials: J
authors.lastname: Devlin
authors.forename: Faye
authors.initials: F
authors.lastname: Owen
authors.forename: Helen
authors.initials: H
authors.lastname: Meadows
mesh_terms: D000328:Adult; D000368:Aged; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D001663:Bilirubin / Q000097:blood; D014408:Biomarkers, Tumor / Q000097:blood; D017323:Dihematoporphyrin Ether / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D014408:Biomarkers, Tumor; D017319:Photosensitizing Agents; D017323:Dihematoporphyrin Ether; D001663:Bilirubin