Gemcitabine alone or in combination with cisplatin in patients with advanced or metastatic cholangiocarcinomas or other biliary tract tumours: A multicentre randomised phase II study- the UK ABC-01 Study

J. W. Valle, H. Wasan, P. Johnson, E. Jones, L. Dixon, R. Swindell, S. Baka, A. Maraveyas, P. Corrie, S. Falk, S. Gollins, F. Lofts, L. Evans, T. Meyer, A. Anthoney, T. Iveson, M. Highley, R. Osborne, J. Bridgewater

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background:We assessed the activity of gemcitabine (G) and cisplatin/gemcitabine (C/G) in patients with locally advanced (LA) or metastatic (M) (advanced) biliary cancers (ABC) for whom there is no standard chemotherapy.Methods:Patients, aged 18 years, with pathologically confirmed ABC, Karnofsky performance (KP) 60, and adequate haematological, hepatic and renal function were randomised to G 1000 mg m 2 on D1, 8, 15 q28d (Arm A) or C 25 mg m 2 followed by G 1000 mg m 2 D1, 8 q21d (Arm B) for up to 6 months or disease progression.Results:In total, 86 patients (A/B, n44/42) were randomised between February 2002 and May 2004. Median age (64/62.5 years), KP, primary tumour site, earlier surgery, indwelling biliary stent and disease stage (LA: 25/38%) are comparable between treatment arms. Grade 3-4 toxicity included (A/B, % patients) anaemia (4.5/2.4), leukopenia (6.8/4.8), neutropenia (13.6/14.3), thrombocytopenia (9.1/11.9), lethargy (9.1/28.6), nausea/vomiting (0/7.1) and anorexia (2.3/4.8). Responses (WHO criteria, % of evaluable patients: A n31 vs B n36): no CRs; PR 22.6 vs 27.8%; SD 35.5 vs 47.1% for a tumour control rate (CRPRSD) of 58.0 vs 75.0%. The median TTP and 6-month progression-free survival (PFS) (the primary end point) were greater in the C/G arm (4.0 vs 8.0 months and 45.5 vs 57.1% in arms A and B, respectively).Conclusion:Both regimens seem active in ABC. C/G is associated with an improved tumour control rate, TTP and 6-month PFS. The study has been extended (ABC-02 study) and powered to determine the effect on overall survival and the quality of life. © 2009 Cancer Research UK.
    Original languageEnglish
    Pages (from-to)621-627
    Number of pages6
    JournalBritish Journal of Cancer
    Volume101
    Issue number4
    DOIs
    Publication statusPublished - 18 Aug 2009

    Keywords

    • Biliary tract
    • Chemotherapy
    • Cholangiocarcinoma
    • Cisplatin
    • Gallbladder cancer
    • Gemcitabine

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