title: Photodynamic therapy in patients with non-resectable hilar cholangiocarcinoma: 5-year follow-up of a prospective phase II study.
abstract: BACKGROUND
  Median survival of patients with non-resectable hilar cholangiocarcinoma is 3 to 6 months, even after biliary drainage. Therefore, a single-arm phase II study was conducted (July 1996 to October 1998) to investigate the effect of local photodynamic therapy; a significant improvement in survival (74%) was noted at 6 months. The present study is an analysis of the long-term follow-up for patients enrolled in that phase II study.
  
  
  METHODS
  Five-year follow-up data for the 23 patients enrolled in the original prospective study were analyzed by using Kaplan-Meier log-rank analysis.
  
  
  RESULTS
  Median survival after treatment was 11.2 months for patients without distant metastases (M0) and 9.3 months for all patients (M0+M1). The 1-year, 2-year, 3-year, and 4-year survival rates were estimated to be 47%, 21%, 11% and 5%, respectively, for patients with stage M0 cholangiocarcinoma, and 39%, 17%, 9%, and 4%, respectively, for patients with stages M0 and M1. Of the patients who died, 73.9% (n=17) were because of tumor progression; 26.1% (n=6) died as a result of cholangitis (n=4), septic shock (n=1), or appendicitis/peritonitis (n=1). For all patients, except one with diffuse liver metastases, there was improvement in cholestasis, performance, and quality of life, which was maintained for an extended period.
  
  
  CONCLUSIONS
  This 5-year follow-up study confirms that photodynamic therapy is safe and effective for non-resectable hilar cholangiocarcinoma, although it does not prevent progression of the disease.
authors.affiliation: Department of Internal Medicine II, University of Leipzig, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiedmann
authors.forename: Frieder
authors.initials: F
authors.lastname: Berr
authors.forename: Ingolf
authors.initials: I
authors.lastname: Schiefke
authors.forename: Helmut
authors.initials: H
authors.lastname: Witzigmann
authors.forename: Kay
authors.initials: K
authors.lastname: Kohlhaw
authors.forename: Joachim
authors.initials: J
authors.lastname: Mössner
authors.forename: Karel
authors.initials: K
authors.lastname: Caca
mesh_terms: D000328:Adult; D000368:Aged; D001650:Bile Duct Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D001663:Bilirubin / Q000097:blood; D018281:Cholangiocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D001663:Bilirubin