title: Phase II study of second line gemcitabine single chemotherapy for biliary tract cancer patients with 5-fluorouracil refractoriness.
abstract: OBJECTIVE
  We conducted this phase II study in an effort to evaluate the efficacy and safety of a gemcitabine single chemotherapy as a second-line treatment for biliary tract cancer (BTC) patients who evidenced disease progression after the administration of 5-fluorouracil (5-FU)-based palliative chemotherapy.
  
  
  METHODS
  Patients treated previously with 5-FU-based palliative treatment as a BTC were enrolled in this study. Treatment consisted of gemcitabine at a dosage of 1,250 mg/m(2) administered intravenously over a 30-minute period on days 1 and 8 of each 21-day cycle until progression.
  
  
  RESULTS
  Between Feb. 2006 and July 2009, a total of 32 patients were assigned to treatment groups. 16 patients (50%) had cancers of intra-hepatic cholangiocarcinoma, 12 patients (37.5%) had gall bladder cancer, and 4 patients (12.5%) had extra-hepatic cholangiocarcinoma. In the 29 patients whose tumor responses were evaluated, two achieved a partial response, with an overall response rate of 6.9% (95% confidence interval [CI]: 0.0-16.7%). Six patients (20.7%) evidenced stable disease and 21 patients (72.4%) evidenced progression during the course of treatment. The median follow-up duration was 23.2 months (range: 3.0-53.1 months). The median time to progression (TTP) was 1.6 months (95% CI: 1.3-1.9 months), and the median overall survival (OS) time was 4.1 months (95% CI: 2.7-5.5 months). Poor performance status (ECOG 2) in patients was predictive of shorter TTP. Lower albumin levels (<3.5 g/dL) in patients were predictive of shorter TTP and OS.
  
  
  CONCLUSIONS
  Despite first salvage chemotherapy in the phase II study for patients with 5-FU refractory BTC, the results in terms of RR, TTP, and OS were lower than expected. However, selected patients with good performance status and sufficient albumin levels may have derived some survival benefits from salvage chemotherapy.
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.forename: Chi Young
authors.initials: CY
authors.lastname: Jeong
authors.forename: Soon Chan
authors.initials: SC
authors.lastname: Hong
authors.forename: Tae Hyo
authors.initials: TH
authors.lastname: Kim
authors.forename: Chang Yoon
authors.initials: CY
authors.lastname: Ha
authors.forename: Hyun Jin
authors.initials: HJ
authors.lastname: Kim
authors.forename: Gyeong-Won
authors.initials: GW
authors.lastname: Lee
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.forename: Joung Soon
authors.initials: JS
authors.lastname: Jang
authors.forename: Hyuk-Chan
authors.initials: HC
authors.lastname: Kwon
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine