title: A pilot study of salvage irinotecan monotherapy for advanced biliary tract cancer.
abstract: OBJECTIVE
  To evaluate the treatment outcomes of irinotecan monotherapy for patients with advanced biliary tract cancer refractory to gemcitabine, cisplatin, and oral fluoropyrimidine.
  
  
  METHODS
  Irinotecan (100 mg/m(2)) was administered intravenously on days 1, 8, and 15, repeated every four weeks.
  
  
  RESULTS
  Thirteen patients were enrolled. The dose intensity was only 55.0%. The response rate and disease control rate were 1/13 (7.7%) and 3/13 (23.1%), respectively. The median overall survival and time-to-progression were 6.7 months (95% confidence interval=3.0-10.4 months) and 1.8 months (95% confidence interval=1.6-3.9 months), respectively. Grade 3/4 adverse events included leukopenia (7/13), neutropenia (8/13), anemia (6/13), nausea (1/13), vomiting (1/13), anorexia (2/13), diarrhea (1/13), and constipation (1/13).
  
  
  CONCLUSIONS
  Irinotecan monotherapy had a modest antitumor effect even for patients who were refractory to gemcitabine, cisplatin, and oral fluoropyrimidine. However, this regimen was not fully tolerated as third-line or fourth-line therapy. Therefore, further evaluation of a modified irinotecan regimen is necessary.
authors.affiliation: Departments of 1Gastroenterology and 2Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Naminatsu
authors.initials: N
authors.lastname: Takahara
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Satoh
authors.forename: Daiya
authors.initials: D
authors.lastname: Takai
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Natsuyo
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yatomi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D014453:Glucuronosyltransferase / Q000235:genetics; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020641:Polymorphism, Single Nucleotide; D016879:Salvage Therapy; D015996:Survival Rate; D059004:Topoisomerase I Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000099148:UGT1A1 Enzyme
chemical_list: D002166:Camptothecin; D014453:Glucuronosyltransferase; D000077146:Irinotecan; D059004:Topoisomerase I Inhibitors; D000099148:UGT1A1 Enzyme
keywords: Biliary tract cancer; cisplatin; fluoropyrimidine; gemcitabine; irinotecan; refractory