title: A pilot study of S-1-based concurrent chemoradiotherapy in patients with biliary tract cancer.
abstract: OBJECTIVE
  S-1 chemotherapy is effective against advanced biliary tract cancer. The purpose was to evaluate the efficacy and safety of S-1-based concurrent chemoradiotherapy in patients with advanced biliary tract cancer.
  
  
  METHODS
  Patients with pathologically-proven advanced biliary tract cancer were eligible. S-1 was orally administered at a dose of 40 mg/m(2), twice daily from day 1 to 14 and from day 22 to 35; concurrent radiotherapy of 180-200 cGy per fraction was delivered in 25-28 fractions. After treatment completion, tumor response was evaluated by computed tomography. In the first stage of the optimal two-stage phase II design, 18 patients were required.
  
  
  RESULTS
  Twenty patients were enrolled between August 2006 and February 2009. The median age was 62.5 years (range 45-77 years). The median follow-up time was 11.6 months (range 1.9-49.1 months). Fifteen patients (75%) had extrahepatic cholangiocarcinoma, two patients (10%) had intrahepatic cholangiocarcinoma, and three patients (15%) had gallbladder cancer. After treatment, a partial response was achieved in three patients (15%), and stable disease was achieved in 14 patients (70%). The overall response rate was 15%, and the disease stabilization rate was 85%. There was no grade 4 toxicity or treatment-related death. The common grade 3 toxicities were thrombocytopenia (15%), neutropenia (10%), and nausea (10%). The median progression-free survival and median overall survival were 5.9 months (range 2.2-9.5 months) and 10.8 months (range 1.1-20.4 months), respectively.
  
  
  CONCLUSIONS
  This study shows that S-1-based concurrent chemoradiotherapy is feasible and tolerable in patients with advanced biliary tract cancer. It will be further confirmed in a following large-scale phase II study.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
authors.forename: Hee Man
authors.initials: HM
authors.lastname: Kim
authors.forename: Kyong Joo
authors.initials: KJ
authors.lastname: Lee
authors.forename: Jihye
authors.initials: J
authors.lastname: Cha
authors.forename: Moon Jae
authors.initials: MJ
authors.lastname: Chung
authors.forename: Seungmin
authors.initials: S
authors.lastname: Bang
authors.forename: Jinsil
authors.initials: J
authors.lastname: Seong
authors.forename: Si Young
authors.initials: SY
authors.lastname: Song
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D059248:Chemoradiotherapy / Q000379:methods*; D018572:Disease-Free Survival; D004338:Drug Combinations; D004354:Drug Screening Assays, Antitumor; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid