title: Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.
abstract: OBJECTIVE
  Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting.
  
  
  METHODS
  Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy.
  
  
  RESULTS
  Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%).
  
  
  CONCLUSIONS
  In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.
authors.affiliation: Eli Lilly Japan K.K., Sannomiya Plaza Bldg. 7-1-5, Isogamidori, Chuo-ku, Kobe 651-0086 Japan. okubo_sumiko@lilly.com
authors.forename: Sumiko
authors.initials: S
authors.lastname: Okubo
authors.forename: Shinichi
authors.initials: S
authors.lastname: Nishiuma
authors.forename: Noriko
authors.initials: N
authors.lastname: Kobayashi
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.forename: Hisashi
authors.initials: H
authors.lastname: Taniai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D044466:Asian People; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000378:metabolism; D014408:Biomarkers, Tumor / Q000032:analysis; D018395:CA-19-9 Antigen / Q000032:analysis; D002272:Carcinoembryonic Antigen / Q000032:analysis; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D002272:Carcinoembryonic Antigen; D003841:Deoxycytidine; D000093542:Gemcitabine