title: Combined modality treatment in unresectable extrahepatic biliary carcinoma.
abstract: OBJECTIVE
  Cancers of the extrahepatic biliary tract are rare. Surgical resection is considered the standard treatment, but is rarely feasible. Several reports of combined modality therapy, including external beam radiation, often combined with chemotherapy and intraluminal brachytherapy, have been published. The purpose of this study was to evaluate the effect of chemoradiation plus intraluminal brachytherapy on response, local control, survival, and symptom relief in patients with unresectable or residual extrahepatic biliary carcinoma.
  
  
  METHODS
  From February 1991 to December 1997, 20 patients (14 male, 6 female; mean age 61 +/- 12 years; median follow-up 71 months) with unresectable (16 patients) or residual (4 patients), nonmetastatic extrahepatic bile tumors (common bile duct, 8; gallbladder, 1; Klatskin, 11) received external beam radiation (39.6-50.4 Gy); in 19 patients, 5-fluorouracil (96-h continuous infusion, days 1-4 at 1,000 mg/m(2)/day) was also administered. Twelve patients received a boost by intraluminal brachytherapy using (192)Ir wires of 30-50 Gy, prescribed 1 cm from the source axis.
  
  
  RESULTS
  During external beam radiotherapy, 8 patients (40%) developed grade 1-2 gastrointestinal toxicity. Four patients treated with external-beam plus intraluminal brachytherapy had a clinical response (2 partial, 2 complete) after treatment. For the total patient group, the median survival and time to local progression was 21.2 and 33.1 months, respectively. Distant metastasis occurred in 10 (50%) patients. Two patients who received external beam radiation plus intraluminal brachytherapy developed late duodenal ulceration. Two patients with unresectable disease survived more than 5 years.
  
  
  CONCLUSIONS
  Our data suggest that chemoradiation plus intraluminal brachytherapy was relatively well-tolerated, and resulted in reasonable local control and median survival. Further follow-up and additional research is needed to determine the ultimate efficacy of this regimen. New chemoradiation combinations and/or new treatment strategies (neoadjuvant chemoradiation) may contribute, in the future, to improve these results.
authors.affiliation: Cattedra di Radioterapia, Universita' Cattolica del Sacro Cuore, Roma, Italy.
authors.forename: A G
authors.initials: AG
authors.lastname: Morganti
authors.forename: L
authors.initials: L
authors.lastname: Trodella
authors.forename: V
authors.initials: V
authors.lastname: Valentini
authors.forename: P
authors.initials: P
authors.lastname: Montemaggi
authors.forename: G
authors.initials: G
authors.lastname: Costamagna
authors.forename: D
authors.initials: D
authors.lastname: Smaniotto
authors.forename: S
authors.initials: S
authors.lastname: Luzi
authors.forename: P
authors.initials: P
authors.lastname: Ziccarelli
authors.forename: G
authors.initials: G
authors.lastname: Macchia
authors.forename: V
authors.initials: V
authors.lastname: Perri
authors.forename: M
authors.initials: M
authors.lastname: Mutignani
authors.forename: N
authors.initials: N
authors.lastname: Cellini
mesh_terms: D000328:Adult; D000368:Aged; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017734:Bile Ducts, Extrahepatic / Q000473:pathology; D001918:Brachytherapy / Q000379:methods; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D017211:Treatment Failure