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    Drug development and clinical trial design in pancreatico-biliary malignancies.

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    Authors
    Harrington, J
    Carter, Louise
    Basu, B
    Cook, Natalie
    Affiliation
    Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK
    Issue Date
    2018-01-08
    
    Metadata
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    Abstract
    Pancreatico-biliary (P-B) tumors arise from the pancreas, bile duct, and ampulla of Vater. Despite their close anatomical location, they have different etiology and biology. However, they uniformly share a poor prognosis, with no major improvements observed in overall survival over decades, even in the face of progress in diagnostic imaging and surgical techniques, and advances in systemic and loco-regional radiation therapies. To date, cytotoxic treatment has been associated with modest benefits in the advanced disease setting, and survival for patients with stage IV disease has not exceeded a year. Therefore, there is a pressing need to identify better treatments which may impact more significantly. Frequently, encouraging signals of potential efficacy for novel agents in early phase clinical trials have been followed by disappointing failures in larger phase III trials, raising the valid question of how drug development can be optimized for patients with pancreatic adenocarcinoma and biliary tract malignancies. In this article we summarize the current therapeutic options for these patients and their limitations. The biological context of these cancers is reviewed, highlighting features that may make them resistant to standard chemotherapeutics and could be potential therapeutic targets. We discuss the role of early phase clinical trials, defined as phase I and non-randomised phase II trials, within the clinical context and current therapeutic landscape of P-B tumors and postulate how translational studies and trial design may enable better realization of emerging targets together with a proposed model for future patient management. A detailed summary of current phase I clinical trials in P-B tumors is provided.
    Citation
    Drug development and clinical trial design in pancreatico-biliary malignancies. 2018, Curr Probl Cancer
    Journal
    Current Problems in Cancer
    URI
    http://hdl.handle.net/10541/620859
    DOI
    10.1016/j.currproblcancer.2018.01.003
    PubMed ID
    29402439
    Type
    Article
    Language
    en
    ISSN
    1535-6345
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.currproblcancer.2018.01.003
    Scopus Count
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