title: A multicenter phase II study of S-1 for gemcitabine-refractory biliary tract cancer.
abstract: OBJECTIVE
  Gemcitabine (GEM)-based chemotherapy has been used worldwide as the first-line treatment for advanced biliary tract cancer (BTC). However, no standard regimens have been established yet for patients with GEM-refractory BTC. A previous phase II trial of S-1 as a first-line treatment in patients with advanced BTC revealed promising activity of this drug. The present study was conducted to evaluate the efficacy and safety of S-1 in patients with GEM-refractory BTC.
  
  
  METHODS
  The subjects were patients with pathologically proven BTC who had shown disease progression while receiving GEM-based chemotherapy. Each treatment cycle consisted of administration of S-1 orally at the dose of 40 mg/m(2) twice daily for 28 days, followed by a rest period of 14 days. The primary endpoint of this study was objective response, and the secondary endpoints were the toxicity, progression-free survival (PFS), and overall survival (OS).
  
  
  RESULTS
  Forty patients were assessed for efficacy and safety from 8 hospitals in Japan between June 2007 and September 2008. There were 3 cases of confirmed partial response (7.5 %) and 22 patients (55 %) of stable disease. The median PFS and OS were 2.5 and 6.8 months, respectively. Toxicity was generally mild, and the most common grade 3 or 4 toxicities were anorexia (10.0 %), anemia (7.5 %), mucositis (7.5 %), hypoalbuminemia (5.0 %), and pneumonia (5.0 %). There were no treatment-related deaths.
  
  
  CONCLUSIONS
  Monotherapy with S-1 was well tolerated, but showed modest efficacy in patients with GEM-refractory BTC.
authors.affiliation: Department of Internal Medicine, Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo 181-8611, Japan. eisuzuki@ks.kyorin-u.ac.jp
authors.forename: Eiichiro
authors.initials: E
authors.lastname: Suzuki
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ikeda
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Shoji
authors.initials: S
authors.lastname: Nakamori
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohkawa
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Nagakawa
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagimoto
authors.forename: Tosiya
authors.initials: T
authors.lastname: Sato
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine