title: A retrospective analysis of the clinical effects of neoadjuvant combination therapy with full-dose gemcitabine and radiation therapy in patients with biliary tract cancer.
abstract: OBJECTIVE
  This study aims to evaluate survival and the objective response to neoadjuvant combination therapy with gemcitabine and radiation therapy in patients with biliary tract cancer.
  
  
  METHODS
  The chemoradiation therapy regimen consisted of 3 cycles of full-dose gemcitabine (1000 mg/m2at days 1, 8, and 15, every 4 weeks) with 50-60 Gy radiation. We compared 27 patients who received neoadjuvant chemoradiation therapy and 79 patients who were treated without neoadjuvant therapy. Hemi-hepatectomy or pancreatoduodenectomy was planned for all of the patients in the study population. CT-based staging was used to adjust for the pre-treatment characteristics of the patients.
  
  
  RESULTS
  After confirming the reproducibility of CT-based staging, we analyzed the survival of the patients. The multivariate analysis showed that the absence of arterial invasion on CT, the absence of lymph node swelling, and neoadjuvant therapy were independent prognostic factors. The three-year recurrence-free survival (RFS) rates in patients treated with and without neoadjuvant therapy were 78% and 58%, respectively (P = 0.0263). The adjusted overall survival (OS) (determined by the inverse probability of treatment weighting method using the inverse propensity score) was improved by neoadjuvant therapy (P = 0.00187); the hazard ratio was 0.3505.
  
  
  CONCLUSIONS
  Neoadjuvant chemoradiation therapy might have the potential to improve RFS and OS.
  
  
  BACKGROUND
  UMIN-CTR UMIN000015450.
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan. Electronic address: s-kobayashi@umin.ac.jp.
authors.forename: S
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Tomokuni
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Gotoh
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Akita
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Marubashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Teshima
authors.affiliation: Center for Cancer Control & Statistics, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Fukui
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Sakon
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D001661:Biliary Tract Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D018281:Cholangiocarcinoma / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005706:Gallbladder Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D006498:Hepatectomy; D006801:Humans; D018285:Klatskin Tumor / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D016577:Pancreaticoduodenectomy; D012189:Retrospective Studies; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: Biliary tract cancer; Chemoradiation; Neoadjuvant; Survival