title: An analysis of a second-line S-1 monotherapy for gemcitabine-refractory biliary tract cancer.
abstract: OBJECTIVE
  Gemcitabine is widely used as a first-line therapy for biliary tract cancer (BTC). However, few studies have been conducted to analyze second- line therapies.
  
  
  METHODS
  From 33 patients who had been administered gemcitabine following resection between May 2005 and August 2007, we retrospectively analyzed the safety and efficacy of S-1 in 11 cases who received S-1 as second-line therapy due to recurrence or relapse of the primary disease.
  
  
  RESULTS
  Among the adverse events (AEs) observed during S-1 administration, the most common was a decrease in the concentration of hemoglobin, followed by thrombocytopenia. No Grade 4 AEs or worse were detected. In addition, the AEs and their respective severity strongly resembled those of gemcitabine used as a first-line therapy. There were 7 cases that could be evaluated according to RECIST criteria, of which 1 was considered in the partial response and 3 as stable disease. The medians of time to progression after S-1 administration and survival after S-1 administration were 5.6 months and 31 months, respectively.
  
  
  CONCLUSIONS
  S-1 could be taken safely as a second-line therapy without provoking severe AEs. By preventing the cessation of S-1 administration due to its AEs, more continued S-1 administration could lead to a better prognosis for BTC.
authors.affiliation: Tohoku University Graduate School of Medicine, Sendai, Japan. y2.katayo@surg1.med.tohoku.ac.jp
authors.forename: Yu
authors.initials: Y
authors.lastname: Katayose
authors.forename: Hideo
authors.initials: H
authors.lastname: Ohtsuka
authors.forename: Yo
authors.initials: Y
authors.lastname: Kitamura
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Masuda
authors.forename: Kei
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Kuniharu
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yoshida
authors.forename: Tohru
authors.initials: T
authors.lastname: Onogawa
authors.forename: Fuyuhiko
authors.initials: F
authors.lastname: Motoi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Naitoh
authors.forename: Toshiki
authors.initials: T
authors.lastname: Rikiyama
authors.forename: Shin-Ichi
authors.initials: S
authors.lastname: Egawa
authors.forename: Michiaki
authors.initials: M
authors.lastname: Unno
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D001662:Biliary Tract Surgical Procedures; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; 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