title: Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer: a meta-analysis.
abstract: OBJECTIVE
  To investigate the efficacy and safety of gemcitabine (Gem)-based combination chemotherapies for the treatment of advanced biliary tract cancer.
  
  
  METHODS
  Clinical trials were identified by searching scientific literature databases (PubMed, EMBASE and the Cochrane Library) for studies published between 1975 and 2013. Two reviewers independently evaluated the relevant studies and manually searched references from these reports to locate additional eligible studies. The disease response and control rates, progression-free and overall survivals, and the grade 3-4 toxicities were evaluated by a meta-analysis. Odds-ratios (ORs) of the disease response and control rates and grade 3-4 toxicities, and the mean difference (MD) of both progression-free and overall survivals were calculated and used for statistical analysis.
  
  
  RESULTS
  Seven randomized trials with a total of 858 patients were selected and included in the final analysis. The studies were divided into subgroups based on the chemotherapy regimens, including Gem-based and non-Gem-based chemotherapies. The overall analyses revealed that the patients treated with Gem-based combination chemotherapy had significantly higher disease response rates [OR = 1.69, 95% confidence interval (CI): 1.17-2.43; P = 0.01], a longer progression-free survival (MD = 1.95, 95%CI: 0.90-3.00; P = 0.00) and a longer overall survival (MD = 1.85, 95%CI: 0.26-3.44; P = 0.02). A higher incidence of grade 3-4 hematological toxicities, including leukopenia (OR = 2.98, 95%CI: 1.44-6.20; P = 0.00), anemia (OR = 2.96, 95%CI: 1.79-4.92; P = 0.00) and neutropenia (OR = 2.80, 95%CI: 1.39-5.64; P = 0.00) was found in the Gem-based combination chemotherapy group compared with the Gem monotherapy and non-Gem-based chemotherapy groups.
  
  
  CONCLUSIONS
  Gem-based combination chemotherapy is a potential first-line treatment for advanced biliary tract cancer as a result of improved survival, though with additional toxicity.
authors.affiliation: Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
authors.forename: Heng
authors.initials: H
authors.lastname: Liu
authors.affiliation: Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
authors.forename: Qi-Di
authors.initials: QD
authors.lastname: Zhang
authors.affiliation: Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
authors.forename: Zheng-Hong
authors.initials: ZH
authors.lastname: Li
authors.affiliation: Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
authors.forename: Qing-Qing
authors.initials: QQ
authors.lastname: Zhang
authors.affiliation: Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
authors.forename: Lun-Gen
authors.initials: LG
authors.lastname: Lu
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016009:Chi-Square Distribution; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D006801:Humans; D016017:Odds Ratio; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: Biliary tract cancer; Combination chemotherapy; Gemcitabine; Meta-analysis; Randomized trial