title: Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study.
abstract: OBJECTIVE
  Complications from biliary drainage in biliary tract cancer (BTC) may influence the relative dose intensity of chemotherapy or increase adverse events during chemotherapy. BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III trial in non-Japanese that demonstrated the effectiveness of gemcitabine plus cisplatin combination therapy (GC) in BTC. The purpose of this exploratory analysis of the BT22 study was to identify the possible effects of biliary drainage on the efficacy and safety of GC or gemcitabine monotherapy (G).
  
  
  METHODS
  The 83 BTC patients who received GC or G in BT22 were retrospectively analysed in two subgroups dependent upon whether biliary drainage was performed before study entry. Efficacy and safety of treatment (GC vs. G) were compared in these two groups.
  
  
  RESULTS
  The GC arm had a higher 1-year survival rate and longer median survival time (MST) than the G arm independent of prior biliary drainage. Patients in the drainage subgroup developed cholangitis more frequently, however, the frequency of grade 3/4 adverse events did not differ between the treatment regimens with/without drainage.
  
  
  CONCLUSIONS
  Biliary drainage before chemotherapy did not affect the therapeutic efficacy or tolerability of chemotherapy using G or GC.
authors.affiliation: Department of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan. a.fukutomi@scchr.jp
authors.forename: Akira
authors.initials: A
authors.lastname: Fukutomi
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Masaru
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.forename: Minori
authors.initials: M
authors.lastname: Koshiji
authors.forename: Yuji
authors.initials: Y
authors.lastname: Nimura
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D002761:Cholangitis / Q000209:etiology; D002945:Cisplatin / Q000008:administration & dosage; D017322:Clinical Trials, Phase II as Topic; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004322:Drainage / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine