@article{3078402,
    title = "First line gemcitabine/pazopanib in locally advanced and/or metastatic biliary tract carcinoma. A hellenic cooperative oncology group Phase II study",
    author = "Sgouros, J. and Aravantinos, G. and Koliou, G.-A. and Pentheroudakis, G. and Zagouri, F. and Psyrri, A. and Lampropoulou, D.I. and Demiri, S. and Pectasides, D. and Razis, E. and Fountzilas, G. and Samantas, E.",
    journal = "ANTICANCER RESEARCH",
    year = "2020",
    volume = "40",
    number = "2",
    pages = "929-938",
    publisher = "International Institute of Anticancer Research",
    issn = "0250-1291",
    doi = "10.21873/anticanres.14026",
    keywords = "gemcitabine;  pazopanib;  antineoplastic agent;  deoxycytidine;  gemcitabine;  pazopanib;  pyrimidine derivative;  sulfonamide, acute kidney failure;  adult;  advanced cancer;  aged;  Article;  bile duct carcinoma;  bleeding;  brain ischemia;  clinical article;  disease control;  disease free survival;  fatigue;  female;  human;  human tissue;  hypertension;  lung abscess;  male;  multicenter study;  overall survival;  phase 2 clinical trial;  priority journal;  progression free survival;  quality of life;  bile duct cancer;  clinical trial;  metastasis;  middle aged;  treatment outcome;  very elderly, Aged;  Aged, 80 and over;  Antineoplastic Combined Chemotherapy Protocols;  Bile Duct Neoplasms;  Deoxycytidine;  Female;  Humans;  Male;  Middle Aged;  Neoplasm Metastasis;  Pyrimidines;  Sulfonamides;  Treatment Outcome",
    abstract = "Background/Aim: The efficacy of gemcitabinebased chemotherapy in locally advanced/metastatic biliary tract carcinoma is limited. The aim of this trial was to assess the activity of a novel gemcitabine-pazopanib combination in such patients. Patients and Methods: In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m2 of gemcitabine on days 1 and 8 every 21 days and 800 mg of pazopanib once daily continuously for 8 cycles, followed by pazopanib maintenance. The primary endpoint was objective response rate (ORR). Results: A total of 29 patients (median age; 69 years) were enrolled between June 2013 and March 2018. The ORR was 13.8% in the intent-to-treat and 19.1% in the per protocol population. The median progression-free and overall survival were 6.3 and 10.4 months, respectively. Conclusion: The low response rate precludes further testing of the combination in patients with biliary tract carcinoma. © 2020 International Institute of Anticancer Research. All rights reserved."
}