title: Evaluation of the safety and pathological effects of neoadjuvant full-dose gemcitabine combination radiation therapy in patients with biliary tract cancer.
abstract: OBJECTIVE
  This study aimed to evaluate the safety of neoadjuvant gemcitabine combination radiation therapy in the treatment of biliary tract cancer and to investigate the pathological effects of chemoradiation therapy and its impact on survival.
  
  
  METHODS
  Chemoradiation therapy entailed three cycles of full dose of gemcitabine (1000 mg/m(2) at days 1, 8, and 15, every 4 weeks) with 50-60 Gy radiation (2 Gy/day) at the main tumor and the regional and para-aortic lymph nodes. The present study included 25 patients.
  
  
  RESULTS
  All of the patients were pathologically diagnosed before treatment. The relative dose intensity of gemcitabine was 84 %. The average dose of radiation was 53.8 Gy. Sixty percent of the patients underwent pancreatoduodenectomy, and 32 % underwent hemi-hepatectomy due to bile duct cancer (n = 24) or gall bladder cancer (n = 1). During neoadjuvant therapy, 21 patients (84 %) suffered from adverse events. The common hematological adverse events were leukopenia (44 %) and thrombocytopenia (32 %). It was necessary to exchange the plastic biliary stent in 11 patients (44 %). An R0 resection was achieved in 96 % of the patients, with pathological lymph node metastasis noted in 16 %. Moderate or marked histological changes were noted in 32 % of the patients. The 3-year overall survival rate after the first treatment was 74.6 %, with a 3.2-year observation period.
  
  
  CONCLUSIONS
  Neoadjuvant therapy was feasible and is expected to improve survival by controlling regional extension.
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan. s-kobayashi@umin.ac.jp.
authors.forename: Shogo
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Tomokuni
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Kunihito
authors.initials: K
authors.lastname: Gotoh
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Akita
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Marubashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Terumasa
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Department of Surgery and Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Teruki
authors.initials: T
authors.lastname: Teshima
authors.affiliation: Department of Surgery and Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Kinji
authors.initials: K
authors.lastname: Nishiyama
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Yano
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ohigashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishikawa
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Nakamichi 1-3-3, Higashinari-ku, Osaka City, Osaka, 537-8511, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Sakon
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D001661:Biliary Tract Neoplasms / Q000601:surgery / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D003248:Constipation / Q000209:etiology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: Biliary tract cancer; Chemoradiation; Feasibility; Neoadjuvant