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    Advanced intrahepatic cholangiocarcinoma: post-hoc analysis of the ABC-01, -02 and -03 clinical trials

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    Authors
    Lamarca, Angela
    Ross, P
    Wasan, H
    Hubner, Richard A
    McNamara, Mairead G
    Lopes, A
    Manoharan, Prakash
    Palmer, D
    Bridgewater, J
    Valle, Juan W
    Affiliation
    Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester
    Issue Date
    2019
    
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    Abstract
    BACKGROUND: The incidence of intrahepatic cholangiocarcinoma (iCCA) is increasing. The aim was to provide reference survival data for patients with advanced iCCA treated with first-line cisplatin-gemcitabine chemotherapy (current standard of care). METHODS: Individual data from patients with iCCA recruited into the prospective, randomised Advanced Biliary tract Cancer (ABC)-01, -02 and -03 studies were retrieved. The prevalence and survival of liver-only iCCA was also assessed. Survival analysis was performed using univariate and multivariable Cox Regression. All statistical tests were two-sided. RESULTS: Of 534 patients recruited into the ABC-01, -02 and -03 studies, 109 (20.4%) had iCCA. Most patients (n?=?86; 78.9%) had metastatic disease at the time of recruitment; 52 patients (47.7%) had liver-only disease. Following randomisation, 66 (60.6%) iCCA patients received cisplatin/gemcitabine. The median progression-free (PFS) and overall survival (OS) was 8.4 months (95%confdence interval [CI] = 5.9-8.9) and 15.4 months (95%CI = 11.1-17.9), respectively. Of these 66 patients, 34 patients (51.5%) had liver-only disease. Following chemotherapy, 30 (45.5%) and 21 (31.8%) were progression free at 3 and 6 months from chemotherapy commencement, respectively. Median OS for patients with liver-only iCCA at diagnosis, and after 3 and 6 months of chemotherapy was 16.7 months (95% confidence interval [CI] = 8.7-20.2), 17.9 (95%CI = 11.7-20.9) and 18.9 (95%CI = 16.7-25.9) months, respectively. Multivariable analysis confirmed that iCCA had a longer OS compared to other non-iCCA BTCs (hazard ratio = 0.58, 95%CI = 0.35-0.95; p-value = 0.03); liver-only iCCA patients also showed longer OS even though findings did not reach statistical significance (hazard ratio = 0.65, 95%CI = 0.36-1.19; p-value = 0.16). CONCLUSIONS: Patients diagnosed with advanced iCCA have a better OS compared to other BTCs; similar trend was identified for patients diagnosed with liver-only iCCA. These findings are to be considered for future clinical trial design.
    Citation
    Lamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, et al. Advanced intrahepatic cholangiocarcinoma: post-hoc analysis of the ABC-01, -02 and -03 clinical trials. J Natl Cancer Inst. 2019.
    Journal
    Journal of the National Cancer Institute
    URI
    http://hdl.handle.net/10541/621905
    DOI
    10.1093/jnci/djz071
    PubMed ID
    31077311
    Additional Links
    https://dx.doi.org/10.1093/jnci/djz071
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1093/jnci/djz071
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