title: Impact of Itraconazole After First-line Chemotherapy on Survival of Patients with Metastatic Biliary Tract Cancer.
abstract: OBJECTIVE
  We evaluated the efficacy and safety of itraconazole after first-line chemotherapy in patients with metastatic biliary tract cancer (BTC).
  
  
  METHODS
  We retrospectively reviewed data from patients with histologically-diagnosed BTC with distant metastases who had received one or more lines of chemotherapy and subsequent itraconazole chemotherapy.
  
  
  RESULTS
  Among 28 enrolled patients, 26 (93%) received docetaxel (35 mg/m(2)), gemcitabine (1,000 mg/m(2)), and carboplatin (AUC4) on day 1 and oral itraconazole solution (400 mg) on days -2 to 2, repeated every 2 weeks. Two patients received docetaxel plus itraconazole with irinotecan. Two complete responses and 14 partial responses were observed, with a response rate of 57%. The median overall survival was 12.0 months. During 160 cycles, 21 (75%) and 17 (61%) patients had grade 3/4 neutropenia and thrombocytopenia, respectively. Two patients (7%) experienced febrile neutropenia.
  
  
  CONCLUSIONS
  Combination chemotherapy with itraconazole after first-line chemotherapy is promising for patients with metastatic BTC.
authors.affiliation: Department of Medical Oncology, Meiwa Hospital, Nishinomiya, Hyogo, Japan Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan tsuba@hyo-med.ac.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsubamoto
authors.affiliation: Department of Medical Oncology, Meiwa Hospital, Nishinomiya, Hyogo, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sonoda
authors.affiliation: Department of Surgery, Meiwa Hospital, Nishinomiya, Hyogo, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ikuta
authors.affiliation: Department of Medical Oncology, Kohnan Hospital, Higashinada-ku, Kobe, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tani
authors.affiliation: Department of Medical Oncology, Meiwa Hospital, Nishinomiya, Hyogo, Japan Department of Obstetrics and Gynecology, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
authors.forename: Kayo
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Surgery, Meiwa Hospital, Nishinomiya, Hyogo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Yamanaka
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017964:Itraconazole
keywords: biliary tract cancer; itraconazole; second-line chemotherapy