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    Lessons from the comparison of two randomized clinical trials using gemcitabine and cisplatin for advanced biliary tract cancer.

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    Authors
    Furuse, J
    Okusaka, T
    Bridgewater, J
    Taketsuna, M
    Wasan, H
    Koshiji, M
    Valle, Juan W
    Affiliation
    Department of Internal Medicine, Medical Oncology, Kyorin University School of Medicine, Shinkawa, Mitaka, Tokyo, Japan.
    Issue Date
    2011-10
    
    Metadata
    Show full item record
    Abstract
    There had been no standard chemotherapy established for advanced biliary tract cancer (BTC) until 2009, when the combination of cisplatin and gemcitabine (GC) was adopted as a first line standard chemotherapy option based on the results from two randomized studies: ABC-02, a UK investigator-initiated trial and the largest randomized phase III study in this tumor type with 410 patients; and BT22, a Japanese, industry-sponsored, randomized phase II study with 83 patients. In this review, investigators from both studies collaborated to compare protocols, patient characteristics, and outcomes of both studies including sub-analyses of study results. Although both studies showed GC combination therapy to be more effective than monotherapy, a detailed comparison revealed disparities between efficacy and safety end-points between the studies, which did not necessarily arise from different populations but from differences in protocol design. This review provides clinicians with insights for advanced BTC clinical study design and interpretation of historical studies.
    Citation
    Lessons from the comparison of two randomized clinical trials using gemcitabine and cisplatin for advanced biliary tract cancer. 2011, 80 (1):31-9 Crit Rev Oncol Hematol
    Journal
    Critical Reviews in Oncology/Hematology
    URI
    http://hdl.handle.net/10541/226172
    DOI
    10.1016/j.critrevonc.2010.10.009
    PubMed ID
    21094052
    Type
    Article
    Language
    en
    ISSN
    1879-0461
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.critrevonc.2010.10.009
    Scopus Count
    Collections
    All Christie Publications
    Medical Oncology

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